Benzoyl Peroxide Research Articles

Организация профилактики и терапии угревой болезни у подростков на современном этапе.

The organization of prevention and treatment of acne in adolescents, necessary to improve the quality of medical dermatological care, has not been studied enough. The purpose of the study: аnalysis of current and potential opportunities for organizing the prevention and treatment of acne in adolescents. Results. The pathophysiological mechanisms of acne development are being reviewed, considering the characteristics of the puberty period, however, the trends in introducing new approaches to the organization of prevention and treatment of acne in adolescents are not expressed, with the exception of antiandrogen therapy. The official organization of treatment for adolescents with acne considers that any stage of acne development is multifactorial and is based on an inflammatory process. The officially recommended main method of treating acne in adolescents is the combined use of topical agents, especially the combination of benzoyl peroxide and the retinoid adapalene. In complex cases, topical treatment is supplemented with systemic therapy with retinoids (isotretinoin). Prevention of side effects of topical treatment (dry skin, hyperemia or cheilitis) is achieved through the use of moisturizing cosmetics or cream with dexpanthenol, respectively. Officially, in the field of acne prevention and therapy, such methods of influencing acne vulgaris as dermatocosmetics and corneo-or enzyme therapy are not used. The use of local and systemic pre- and probiotics for the treatment of acne has not been introduced. This reveals a connection between the development of acne and the intestinal microbiome. The use of local antiandrogens and insulin-like growth factor 1 inhibitors to control sebum production, as well as selective retinoic acid receptor agonists with a better safety profile compared to retinoid therapy for acne, may be promising for the prevention and treatment of acne in adolescents. Findings. Organization of effective treatment of acne in adolescents should include their clear instructions and correction of dietary habits. Prevention of acne today is practically not organized in the field of medical services.

Construction of a double-increasing emission fluorescent probe and its application in food detection of benzoyl peroxide and biosystem imaging

In this work, based on the Förster resonance energy transfer (FRET) mechanism strategy, a new dual-increasing emission proportional near-infrared (NIR) fluorescent probe Lay-1 was designed for fast benzoyl peroxide (BPO) detection in real food samples and biosystems. Specifically, it employed a naphthylimide derivative and a NIR fluorophore dicyanoisophorone derivative as the energy transfer donor and acceptor, respectively, and a phenylboronic acid (Ph-B(OH)2) as the responding group of BPO. In addition, the results exhibited that the fluorescence color of Lay-1 was changed from red to orange in the absence and the presence of BPO with a fast response time (∼120 s), high sensitivity, and an excellent limit of detection as low as 60.8 nM. Impressively, Lay-1 has been successfully used for BPO detection in real food samples and biosystems with satisfactory results. Therefore, Lay-1 can be a robust molecular tool to further investigate the physiological and pathological function of BPO.

Investigation of the decomposition behavior of the fluoroalkyl acrylate homopolymer and its grafted copolymers onto high-density polyethylene

In this study, the thermal degradation behavior of both poly(3,3,4,4,5,5,6,6,7,7,8,8,8-dodecafluoro-5-methyloctyl-4-(acryloyloxy) benzoate), poly(ABCF13) and its graft copolymers onto high-density polyethylene (HDPE) was investigated in detail. The homopolymers and grafted copolymers were synthesized using the bulk-melt polymerization method in the presence of benzoyl peroxide; 10% and 40% of ABCF13 were used in the graft copolymers. The combined analytical technique, Thermo Gravimetric Analysis coupled with Fourier Transform Infrared Spectroscopy (TGA/FTIR), was utilized to understand the obtained products' thermal behavior and formed decomposition chemicals. The thermal tests were carried out in both air and N2 atmospheres. The experimental results showed that the first weight loss of poly(ABCF13) in air and N2 atmospheres started at about 226°C (1.00%), and the primary and early decomposition product was determined as CO2. The weight loss pattern in graft copolymers at lower concentrations closely resembled that of the homopolymer. However, at higher concentrations, the resulting products exhibited a distinct decomposition mechanism characterized by a gradual decrease in trend. This segmented behavior may indicate the coexistence of the homopolymer and grafted copolymers within the matrix. Moreover, the findings showed that the semi-fluorinated grafted unit had a substantial retardation effect on the polymer.

Formation of polymers in the presence of dispersed mineral phase

The adsorption of oligomeric peroxide of sebacic acid on aerosols was studied. The parameters of the adsorption process were found. The effect of aerosil on the polymerization of styrene (ST), methyl acrylate (MA), butyl acrylate (BA), methyl methacrylate (MMA) and butyl methacrylate (BMA) was studied. The initiators used were oligomeric sebacic acid peroxide (OPSA), benzoyl peroxide (BP), lauryl peroxide (PL) and didecanoyl diperoxy adipinate (DP). The mineral filler increases the polymerization rate of MMA, BMA, MA, BA initiated by OPSA. Under the same conditions, the polymerization rate of ST decreases with an increase in the aerosil content in the polymerization system. BP practically does not affect the polymerization rate of vinyl monomers in the presence of aerosil. The reaction of thermal decomposition of OPSA, DP, PL and BP in styrene in the presence of aerosol was studied. An increase in the content of aerosil leads to an increase in the effective decomposition constant of OPSA, DP, PL. in the case of BP, aerosil has practically no effect on the decomposition rate.

Rosacea in Older Adults and Pharmacologic Treatments.

Rosacea is a chronic inflammatory skin condition that is often more severe in older patients. The main clinical features are erythema, telangiectasia, and inflammatory lesions of the face. The pathogenesis of this condition is not fully understood but certainly multifaceted. Immune and inflammatory dysregulation, genetics, neurogenic dysregulation, microbiome dysbiosis, and systemic disease have all been implicated in rosacea pathogenesis. As we better understand the various pathways that lead to rosacea, we acknowledge that the different symptoms may have unique underlying triggers and mechanisms. Aging also impacts rosacea diagnosis and treatment. Older adults have more severe rosacea symptoms while also having more sensitive and fragile skin than younger patients; therefore, rosacea treatments for older patients require a balance between delivering adequate potency while also minimizing skin irritation and other adverse effects. Until recently, rosacea diagnoses were based on concrete subtypes that did not necessarily capture each patient's manifestation of rosacea. There is now an emphasis on more personalized phenotype-based diagnoses and treatments, which allows for more emphasis on treating individual symptoms and accounting for the unique characteristics of older patients. Centrofacial erythema is best treated with brimonidine and oxymetazoline, while phymatous change and telangiectasia are best treated with surgery and laser ablation. Treatment for rosacea papules and pustules ranges from topicals, such as azelaic acid, ivermectin, metronidazole, minocycline, and encapsulated benzoyl peroxide, to systemics, such as doxycycline and isotretinoin. It is important to understand these treatments in relation to adverse effects and drug interactions that may specifically arise in older populations to provide optimal care. As we advance in understanding rosacea's pathogenesis and adopt personalized phenotype-based approaches, optimizing care for older patients becomes crucial. Continued research into novel treatments is essential to address their unique needs.

A review of the topical management of acne and its associated sequelae in the Asia-Pacific region with a spotlight on trifarotene.

Acne, a highly prevalent skin disease, can be particularly bothersome for patients of Asian background because of its impact on self-confidence and social interactions. In addition to active acne lesions, some patients may develop sequelae such as scarring, macular/postinflammatory hyperpigmentation, or erythema. The tendency of Asian skin to develop sequelae because of its increased susceptibility to irritation, cultural preferences for lighter skin phototypes, and differences in skincare regimens may all contribute to the increased burden of acne. Moreover, many Asia-Pacific countries do not have their own guidelines for acne management, and those that do often have no schedule in place for regular updates. In this article, we provide a critical review of the published guidance for the management of acne and its sequelae in the Asia-Pacific region, identifying gaps in current recommendations that could be addressed to enhance standards of acne care in Asia-Pacific countries. Along with highlighting the importance of a comprehensive skincare regimen to increase treatment efficacy and adherence, we discuss topical retinoids and retinoid combination options in the acne armamentarium that may be beneficial for sequelae prevention and management, such as adapalene 0.3% ± benzoyl peroxide 2.5%, tretinoin 0.05%, tazarotene 0.1%, and trifarotene 0.005%. In particular, trifarotene 0.005% has been observed to significantly reduce acne scar counts in a Phase 4 study. The recent data highlight the need to establish up-to-date guidance for acne and acne sequelae management in Asia-Pacific countries to provide optimal care to Asian patients.

Topical Preparations for Reducing Cutibacterium acnes Infections in Shoulder Surgery: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials

Background: Cutibacterium acnes (C acnes) is a commensal skin bacterium, primarily found in sebaceous glands and hair follicles, with a high prevalence in the shoulder region. It is the most common pathogenic organism in prosthetic joint infections after shoulder arthroplasty. Because of its low virulence, its diagnosis remains difficult. Purpose: To evaluate the relative effects of topical preparations in reducing C acnes in shoulder surgery. Study Design: Meta-analysis; Level of evidence, 1. Methods: We searched the MEDLINE, Embase, PsychINFO, and Cochrane Library databases in March 2022. Randomized controlled trials (RCTs) comparing any form of topical preparation in arthroscopic or open shoulder surgery were included. The primary outcome was a reduction in the number of positive C acnes cultures. Secondary outcomes were adverse events related to the application of topical preparations. We performed a network meta-analysis to facilitate simultaneous comparisons between multiple preparations across studies. We calculated differences between preparations using odds ratios and their 95% CIs. The risk of bias was assessed using the Cochrane risk-of-bias tool. Results: The search yielded 17 RCTs (1350 patients), of which 9 were suitable for the network meta-analysis (775 patients). Overall, 2 RCTs were deemed as having a low risk of bias, and 15 raised “some concerns” of bias. Preparations included benzoyl peroxide (BPO), BPO combined with clindamycin, chlorhexidine gluconate, hydrogen peroxide, povidone-iodine, and water with soap. Only BPO resulted in significantly lower odds of a positive C acnes culture compared with placebo or soap and water (odds ratio, 0.12 [95% CI, 0.04-0.36]). There was no statistically significant difference with all other topical preparations. The only adverse events were skin irritation from BPO and chlorhexidine gluconate in a small number of reported cases. Conclusion: BPO was the most effective topical agent in reducing the prevalence of C acnes in shoulder surgery. These results were limited by a combination of indirect and direct data. Future studies should focus on establishing the optimal frequency and duration of preoperative BPO to further reduce the burden of C acnes. Registration: CRD42022310312 (PROSPERO).

Treatments for Moderate-to-Severe Acne Vulgaris: A Systematic Review and Network Meta-analysis.

Multiple treatment options exist for the management of moderate-to-severe acne. However, the comparative effectiveness (efficacy/safety) of moderate-to-severe acne treatments has not been systematically examined. A systematic literature review (SLR) was conducted to identify randomized controlled trials of ≥4 weeks of treatment (topical, oral, physical, or combinations) for moderate-to-severe facial acne in patients aged ≥9 years. Efficacy outcomes included: percentage of patients achieving ≥2-grade reduction from baseline and “clear” or “almost clear” for global severity score (treatment success); absolute change in inflammatory (ILs reduction); and noninflammatory lesion counts (NILs reduction). A random-effects network meta-analysis (NMA) was conducted for the efficacy outcomes. Treatments were ranked with posterior rank plots and surface under cumulative ranking values.  Results: Eighty-five studies were included in the SLR/NMA. Topical triple-agent fixed-dose combination (FDC) gel (clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) and combinations of double-agent fixed-dose topical treatments with oral antibiotics (TOA3) consistently ranked in the top 3 treatments. Topical triple-agent FDC gel was numerically superior to TOA3 for treatment success (log-odds ratios: 1.84 [95% credible interval (CrI) 1.36 to 2.29]) and 1.69 (95% CrI: 1.01 to 2.32) vs placebo/vehicle). TOA3 was numerically superior to topical triple-agent FDC gel for reduction of ILs (mean difference: -8.21 [-10.33 to -6.13]) and -10.40 [-13.44 to -7.14] vs placebo/vehicle) and NILs (mean difference: -13.41 [-16.69 to -10.32] and -17.74 [-22.56 to -12.85] vs placebo/vehicle). Based on this SLR/NMA, topical triple-agent FDC gel was the most efficacious and safe treatment for moderate-to-severe acne. J Drugs Dermatol. 2024;23(4):     doi:10.36849/JDD.8148.

A Triple Shape Memory Material of Trans‐Polyisoprene/Polycaprolactone with Customizable Response Temperature Controlled by Crosslinking Density

AbstractBody‐temperature responsive shape memory polymers (SMPs) attract a lot of attention with the application in biomedicine. Multiple SMPs regulate the response temperature through the proportion of their stationary and reversible phases by changing the molecular weight of the polymer or the components of the composite. Herein, a crosslinking reaction of trans‐polyisoprene (TPI) and polycaprolactone (PCL) initiated by benzoyl peroxide gave a SMP of TPI/PCL, whose shape memory property is realized by stage‐division crystallization zone. Under the fixed ratio of TPI:PCL, the crystallization performance of TPI/PCL is controlled by the crosslinking density. The response temperatures of the components in TPI/PCL are selected for the stage‐division crystallization zone, making excellent shape memory performance at corresponding response temperatures. For the further achievement in controllable response temperature within a certain range, the relationship model between crosslinking density and response temperature is established, obtaining the customizable response temperature ranging 37–55 °C. The presented facile regulation method for response temperature will provide a new idea for the SMPs development.

Analisis Pengaruh Penambahan Magnesium Oksida terhadap Sifat Mekanis Bioadhesif Berbasis Kitosan-Karagenan

This study investigates the effect of magnesium oxide (MgO) as a filler in enhancing the bioadhesive properties of chitosan and carrageenan-based adhesives. The primary focus is on improving tensile strength, viscosity, solid content, and thermal properties. The results indicate that the addition of 0.75% w/v MgO significantly increased tensile strength from 9.76 kPa to 21.76 kPa and viscosity from 34.26 cP to 617 cP with a 0.5% w/v MgO addition. The solid content also increased from 9.81% to 13.19% with increased MgO concentration. The addition of benzoyl peroxide (BPO) reduced curing time, enhancing process efficiency. Scanning Electron Microscopy and Fourier Transform Infrared Spectroscopy confirmed improvements in structural and chemical stability, while Differential Scanning Calorimetry showed better curing efficiency. This study suggests MgO as a potential filler to improve mechanical properties and adhesion of bioadhesives, relevant for medical applications.

Experience with the fixed combination of benzoyl peroxide and clindamycin in acne therapy

Background. Acne is one of the most common dermatoses, affecting more than 9% of the world’s population. Acne negatively affects the patient’s quality of life and self-esteem, often leading to the development of anxiety and depression. The combination of pharmacological drugs with different mechanisms of action in one external dosage form can provide higher therapeutic efficacy.
 Aims. To evaluate the effectiveness and tolerability of a combination drug with a fixed dose of clindamycin 1% and benzoyl peroxide 5% in the treatment of patients with mild to moderate papulopustular acne.
 Methods. A single-center, open-label, observational, prospective study lasting 6 weeks was performed, which included 40 patients with mild to moderate papulopustular acne who received a gel with a fixed dose of clindamycin 1% and benzoyl peroxide 5% once a day. A clinical assessment of the effectiveness of therapy was carried out, PH, greasiness and moisture of the facial skin were measured, and the dynamics of the dermatological quality of life index was studied.
 Results. The proportion of patients who showed significant improvement at the end of 6 weeks of treatment was 32/40 (80%). The total proportion of patients who showed significant and moderate improvement at the end of therapy reached 36/40 (90%).
 Conclusion. The results obtained showed the high therapeutic effectiveness of the gel with a fixed dose of clindamycin 1% and benzoyl peroxide 5% in the treatment of mild to moderate papulopustular acne.

Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Females with Moderate to Severe Acne: Post Hoc Analysis by Age

Introduction: While acne is common in adolescents, the overall prevalence in adults is increasing, especially among females. In addition, acne in older females is associated with greater negative impacts on quality of life. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% (CAB) gel—the first fixed-dose, triple-combination topical product approved for acne—has demonstrated good efficacy, safety, and tolerability in participants with moderate-to-severe acne. The objective of this analysis is to assess the impact of age on efficacy, safety, and tolerability in females with moderate-to-severe acne.
 Methods: In one phase 2 (N=741; NCT03170388) and two identically designed phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, randomized, 12-week studies, participants aged ≥9 years with moderate-to-severe acne were randomized to receive once-daily CAB or vehicle gel; the phase 2 study included three additional dyad randomization arms (data not shown). Coprimary endpoints comprised inflammatory and noninflammatory lesion counts and treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and score of ‘clear’ or ‘almost clear’). Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were also assessed. Pooled data from these studies were analyzed post hoc from female participants categorized by age: 9-24 years (n=274) and ≥25 years (n=121).
 Results: At week 12 in both age groups, least-squares mean percent reductions from baseline were >70% in CAB-treated females versus vehicle gel for inflammatory (9-24 y: 77.8% vs 53.8%; ≥25 y: 77.8% vs 60.5%; P<0.01, both) and noninflammatory lesions (9-24 y: 72.8% vs 44.5%; ≥25 y: 73.7% vs 55.2%; P<0.001, both). Half of CAB-treated females in both age groups achieved treatment success at week 12 versus less than one-quarter with vehicle (9-24 y: 54.1% vs 15.6%; ≥25 y: 50.1% vs 22.5%; P<0.01, both). Most TEAEs were mild-to-moderate in severity, with rates similar to the overall pooled phase 2 and 3 populations. Although there were transient increases in the severity of cutaneous safety/tolerability assessments with CAB, scores generally returned to or near baseline levels for most assessments by week 12 in younger and older females. No notable age-related trends in safety were observed.
 Conclusions: With greater than 70% lesion reductions and half of participants achieving treatment success by week 12, the innovative, fixed-dose triple combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel demonstrated good efficacy, safety, and tolerability in both younger and older females with moderate-to-severe acne.
 Funding: Ortho Dermatologics

Efficacy and Safety of Fixed-Dose Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne Vulgaris in Children and Adolescents

Background: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the first fixed-dose triple-combination formulation approved for acne vulgaris and is indicated for use in patients aged 12 years and older. As topical acne treatment in pediatric patients may be complicated by tolerability issues and/or a perceived lack of efficacy, the objective of this post hoc analysis was to investigate the efficacy and safety of CAB in children and adolescents.
 Methods: Data were pooled from two phase 3 double-blind, randomized, 12-week studies (NCT04214639; NCT04214652). Eligible participants ≥9 years of age with moderate-to-severe acne were randomized (2:1) to once-daily CAB or vehicle gel. This analysis evaluated adolescents aged 12-17 years (CAB: n=123; vehicle: n=50). Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success), least-squares mean percent change from baseline in inflammatory/noninflammatory lesions, and treatment-emergent adverse events (TEAEs). Descriptive efficacy and safety data for five children aged 10-11 years enrolled in the study are also summarized (CAB: n=3; vehicle: n=2).
 Results: At week 12, 51.5% of CAB–treated participants aged ≥12 years achieved treatment success vs 24.9% with vehicle gel (P<0.01). CAB treatment resulted in significant reductions of >70% in inflammatory and noninflammatory lesion counts in adolescents (78.3% and 73.7%, respectively) vs vehicle (50.5% and 42.9%; P<0.001, both). Most TEAEs were of mild-to-moderate severity, and the most common (>3% in any treatment) treatment-related TEAE was application site pain. Less than 2.5% of participants withdrew due to AEs. For the 5 children aged <12 years, all 3 treated with CAB achieved treatment success, with reductions in inflammatory/noninflammatory lesions ranging from 76%-100%; neither vehicle-treated participant achieved treatment success. Only one CAB–treated younger participant experienced TEAEs (application site pain/dryness, and erythema [all mild/moderate]) and none discontinued the study.
 Conclusions: In two pooled phase 3 studies, once-daily CAB gel—the first approved fixed-dose, triple-combination topical formulation for acne vulgaris—was well tolerated and efficacious in pediatric participants with moderate-to-severe acne, with over half achieving treatment success at week 12.
 Funding: Ortho Dermatologics

Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Acne: Clinical Efficacy and Application Characteristics

Background: Triple-combination therapies for acne including an antibiotic, topical retinoid, and benzoyl peroxide (BPO) are among the most effective, with meta-analyses demonstrating greater efficacy with triple-combinations than dual-combinations or topical monotherapy. However, this benefit may be offset by reduced adherence to a complicated treatment regimen. Here, the clinical efficacy of fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% (CAB) gel is reviewed, and the ease of CAB application is compared with the layered application of its individual active ingredients.
 Methods: In a phase 2 (N=741) and two phase 3 (N=183; N=180), double-blind, randomized, 12-week studies, participants aged ≥9 years with moderate-to-severe acne were randomized to receive once-daily CAB or vehicle; the phase 2 study also included treatment arms containing dyad gels (BPO/adapalene; clindamycin phosphate/BPO; clindamycin phosphate/adapalene). Efficacy endpoints included treatment success (percentage of participants achieving ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and reductions from baseline in inflammatory (IL) and noninflammatory lesions (NIL). In a split-face study of adults with acne-prone skin (N=25), participant-application of CAB (0.3 cc) was compared to sequential, layered application of benzoyl peroxide cream, adapalene gel, and clindamycin gel (0.1 cc each). IDP-126 and clindamycin gels were compounded with pyranine, which fluoresces under blue light; photos were taken under blue light to assess evenness of product application.
 Results: In all three clinical studies at week 12, half of CAB-treated participants achieved treatment success (range: 49.6%-52.5%), significantly greater than with vehicle (8.1%-24.9%; P<0.01, all) or dyads (phase 2 study only; 27.8%-30.5%; P≤0.001, all). Reductions from baseline in both IL and NIL were also significantly greater for CAB vs vehicle (range, IL: 75.7%-80.1% vs 50.4%-59.6%; NIL: 71.0%-73.3% vs 45.8%-49.0%; P<0.001, all) and dyads (IL: 64.0%-69.2%; NIL: 58.7%-61.1%; P<0.01, all vs IDP-126). In the split-face study, 100% of Investigator and participant assessments of evenness of application favored CAB over the three layered products. In addition, all participants rated CAB as both easier and faster to apply, and most (96%) preferred CAB for use at home.
 Conclusions: Fixed-dose CAB gel applied more evenly than separate application of its three active ingredients, and demonstrated significantly greater efficacy in the treatment of moderate-to-severe acne than dyad gels or vehicle. By addressing three of the main acne pathogenic pathways in a single, easy-to-apply formulation, CAB may improve efficacy of and adherence to acne treatment.
 Funding: Ortho Dermatologics

Early Acne Improvements With Fixed-Dose Clindamycin Phosphate 1.2%/ Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: What to Expect in the First 4 Weeks of Treatment

Background: Treatments with fast and substantial acne clearance are highly desirable. While a three-pronged approach may increase treatment efficacy versus monotherapy or dual-combination therapy, it is unknown if triple-combination provides more rapid improvement. CAB gel—clindamycin phosphate (clin) 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1%—is the first fixed-dose, triple-combination acne topical. Since rapid/substantial acne improvements and fewer side effects can increase adherence, the efficacy and safety of CAB in the first 4 weeks of treatment was evaluated.
 Methods: In a phase 2 (N=741; NCT03170388) and two phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, 12-week studies, participants aged ≥9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel; the phase 2 study included 3 additional dyad arms: BPO/adapalene; clin/BPO; and clin/adapalene. Efficacy assessments included least-squares mean percent change from baseline in inflammatory and noninflammatory lesions. Cutaneous safety/ tolerability assessments were graded from 0=none to 3=severe. Post hoc analyses included percentages of participants with one-third and one-half acne lesion reductions.
 Results: At week 4, CAB led to ~55% reductions from baseline in inflammatory acne lesions in the ph2 and pooled ph3 studies, significantly greater than vehicle (~40%) and its 3 dyads (ph2 range: 44.2-47.6%; P<0.05, all). The percentages of participants with one-third and one-half reductions of inflammatory lesions were significantly greater with CAB than vehicle and dyads (P<0.05, all). Similar trends were observed for noninflammatory lesions, though reductions were less pronounced. As expected for retinoids, transient increases from baseline to week 2 in scaling, erythema, itching, burning, and stinging were observed for CAB, BPO/adapalene, and clin/adapalene, with mean scores ≤0.6 (1=mild); no trends in dyspigmentation were observed. Mean scores for all cutaneous assessments were highest for BPO/adapalene, indicating that adding a third product in the fixed-dose CAB gel formulation did not worsen tolerability.
 Conclusions: Acne lesion reductions were significantly greater with clin 1.2%/ adapalene 0.15%/BPO 3.1% gel versus its dyads and vehicle gel as early as week 4. More rapid efficacy with this first fixed-dose triple-combination acne product—coupled with its optimized formulation, once-daily dosing, and tolerability—may positively impact treatment adherence.
 Funding: Ortho Dermatologics.

Apremilast for the Treatment of Psoriasis in Special Areas in Pediatric Patients in the SPROUT Study

Introduction & Objective: Psoriasis in special areas is difficult to treat and causes significant disease burden. Approved systemic therapies for moderate to severe plaque psoriasis in pediatric patients are limited and require subcutaneous injection. Apremilast, a unique oral immunomodulator that inhibits phosphodiesterase-4, is approved in multiple countries for use in adults with psoriasis, regardless of severity. In this study, the efficacy of apremilast for psoriasis in special areas in pediatric patients was assessed over 16 weeks. Materials & Methods: SPROUT (NCT03701763) is a phase 3, randomized, double-blind, placebo-controlled study in patients 6-17 years with moderate to severe plaque psoriasis (Psoriasis Area and Severity Index ≥12, body surface area ≥10%, and static Physician Global Assessment [sPGA] ≥3) inadequately controlled by/inappropriate for topical therapy. Patients were stratified by age and randomized 2:1 to receive apremilast (weight-based 20 mg or 30 mg twice-a-day) or placebo for 16 weeks, then apremilast through week 52. Scalp Physician Global Assessment (ScPGA) response, modified sPGA of genitalia (sPGA-G) response, Whole Body Itch-Numeric Rating Scale (WBI-NRS) response, and change from baseline in Children’s Dermatology Life Quality Index (CDLQI) were assessed through week 16. Results: Of 245 randomized patients (apremilast: 163; placebo: 82), 101 (41.2%) were 6-11 years and 144 (58.8%) were 12-17 years; 120 (49.0%) patients weighed ≥20 to <50 kg and 125 (51.0%) weighed ≥50 kg. At baseline, 81.0% of the patients treated with apremilast and 84.1% of patients treated with placebo had moderate to severe scalp psoriasis (ScPGA ≥3). Significantly more patients achieved ScPGA response at week 16 with apremilast vs placebo (36.4% vs 18.8%; P=0.0091). At baseline, 110 patients (44.9%; 45.4% apremilast and 43.9% placebo) had moderate to severe genital psoriasis (sPGA-G ≥3). Achievement of sPGA-G response at week 16 was numerically greater with apremilast vs placebo (39.2% vs 25.0%), although not significant, possibly due to small sample size (apremilast: n=74; placebo: n=36). Significantly more patients achieved WBI-NRS response at week 16 with apremilast vs placebo (52.0% vs 32.1%; P=0.0110). Greater improvements in CDLQI were seen at week 16 with apremilast vs placebo (least-squares mean change from baseline −5.1 vs −3.2; P=0.0009). Adverse events were consistent with the known apremilast safety profile. In 21 patients vaccinated during the study (including for COVID-19, influenza, diphtheria, pertussis, tetanus, meningococcus, and hepatitis B), no new safety issues occurred. Conclusions: Apremilast significantly improved scalp psoriasis, itch, and quality of life in pediatric patients with moderate to severe psoriasis. At week 16, patients with moderate to severe genital psoriasis showed a trend toward improvement, although not significant due partially to the sample size.

Maintenance Acne Treatment With Topical Tazarotene after Oral Isotretinoin: Overview and Case Reports

Introduction: Acne vulgaris is a common dermatologic disorder that may require treatment over months or years. Acne negatively impacts quality of life, and acne of any severity increases the risk of long-term sequelae such as scarring. Common treatments for severe/nodulocystic acne include oral isotretinoin, an oral antibiotic combined with a topical (benzoyl peroxide or a retinoid), an oral combined contraceptive, or oral spironolactone (females). Though oral antibiotics and isotretinoin are not recommended for long-term use, there is scarce guidance or published research on maintenance therapy. Topical retinoids—a mainstay of initial acne treatment—may be prescribed for maintenance once initial oral treatments are complete. Additionally, some retinoids such as tretinoin and tazarotene are indicated for the treatment of fine wrinkles and certain pigmentation disorders, and some studies have shown that adapalene and tazarotene may also reduce acne-induced scarring. Tazarotene 0.045% polymeric emulsion lotion is a well-tolerated retinoid that has demonstrated efficacy in acne treatment and may reduce acne-induced post-inflammatory hyperpigmentation (PIH) and melasma. Further, tazarotene lotion provides rapid and sustained improvements in skin barrier function/moisturization. Herein is presented a report of patients with acne who received maintenance treatment with topical tazarotene 0.045% lotion after an initial course of oral isotretinoin.
 Methods: Patients with severe recalcitrant acne vulgaris were treated with once daily oral isotretinoin for at least 20 weeks until deemed clinically clear. All patients received 40 mg isotretinoin once daily for the first 30 days. The dosage was then increased to 1 mg/kg of bodyweight (treatment naïve) or 1.5 mg/kg (repeat treatment). After 20 weeks, patients who achieved clinically clear skin initiated once-daily topical tazarotene 0.045% lotion monotherapy on the day of their last isotretinoin dose. Follow up visits occurred at 6 months and 1-year post-isotretinoin treatment.
 Results: Patients (n=12) had a mean age of 17.8 years (standard deviation [SD]: 3.8) and the majority were female (58.3%) and White (66.7%). Oral isotretinoin was used for an average of 24.3 weeks (SD: 6.7), with a mean cumulative dose of 184.6 mg/kg. One patient required a repeat course of isotretinoin prior to tazarotene initiation. Post-isotretinoin, patients received tazarotene 0.045% lotion for an average of 13.0 months (SD: 6.7). No patients relapsed and all showed subjective visual improvements in acne-related scarring with tazarotene maintenance treatment. None discontinued tazarotene lotion due to adverse events. 
 Conclusions: There is little guidance or research published on acne maintenance treatment after initial oral isotretinoin or other treatments are complete. Topical tazarotene 0.045% polymeric emulsion lotion has previously demonstrated good efficacy, safety, and tolerability with acne and PIH reductions in patients with moderate-to-severe acne, as well as dyspigmentation reductions in patients with melasma and/or PIH. The case reports presented here show that tazarotene 0.045% lotion may be an effective and safe treatment to prevent relapse after initial oral isotretinoin treatment for severe recalcitrant acne.
 Funding: Ortho Dermatologics

Expert dialogue on topical minocycline gel in acne vulgaris: minologue India

Acne vulgaris is a common skin disorder with a global prevalence of about 9.4%. Oral antibacterials are recommended but they are associated with potential systemic side effects. Topical minocycline 4% has been recently approved by the United States Food and Drug Administration (US-FDA) for the management of moderate to severe acne. Although efficacy and safety are established, little is known of its real word usage. To review and appraise existing literature and make recommendations on the real world usage and positioning of topical minocycline 4% in acne management. The minocycline 4% consensus was developed by nine acne experts and was evidence-based on a review of recent topical minocycline 4% literature. A total of 11 questions were discussed regarding different domains like positioning of topical minocycline in acne management as monotherapy and combination therapy, safety and use in special population. Several recommendations were given regarding topical minocycline use like: no monotherapy use; consider use in combination with other anti-acne treatments like isotretinoin, adapalene and benzoyl peroxide; not recommended to be combined with systemic antibiotics; low chances for hyperpigmentation; use of sun protection measures; consider risk benefit ratio in pregnancy; use in lactation not recommended; and can be used only in children >9 years of age. This consensus has discussed and answered many real world usage questions and place in therapy for topical minocycline in acne management and finds it a useful addition to the existing armamentarium.

Cost Analysis Study of Topical Anti-Acne Drugs Currently Available in Indian Pharmaceutical Market

Acne vulgaris is a chronic inflammatory skin disease that affects approximately 90% individuals between puberty and 30 years of age at some point with peak prevalence in adolescence. According to Global Burden of Disease study conducted in 187 countries in 2010, acne is among top ten most prevalent disease worldwide and skin conditions are top cause of years lived with disability. The aim of the study was to analyze cost variations of different brands of topical medications used in Acne vulgaris in India. This analytical study was conducted in the Department of Pharmacology at Assam Medical College and Hospital over a period of 3 months. ‘‘Current Index of Medical Specialities (CIMS)’’ April - July, 2023 and “Drug Today India April –July 2023’’ drug manuals were used to compare cost of different formulations of topical acne medications. Drugs manufactured by only 1 company were excluded. Cost ratio (Maximum cost/ Minimum cost) and percentage cost variation ([{Max cost – Min cost}/ Min cost] *100) were calculated. For single preparations, the percentage cost variation was maximum for Clindamycin 1% 20 grams gel (1126.66%) with maximum cost ratio followed by Tretinoin 20 gm 0.025% (cream) 721.428. Percentage cost variation was minimum with Adapalene 0.1 % cream 15gm (32.69). Among the combination topical drugs, the percentage cost variation was maximum for Clindamycin 1% + Adapalene 0.1% 15 grams gel (1843.589) and it had maximum cost ratio of 19.43. Percentage cost variation was minimum with combination of Benzoyl Peroxide 2.5% + Clindamycin 1% 20gm gel(41.025).This study highlights price variation among different brands of drugs in CIMS, Drug Today and Pharma Sahi Daam app. Keywords Cost Analysis, Acne vulgaris, Percentage Cost­Variation, Pharma Sahi Daam

Prediction Of Raman Spectra and Adulteration Concentration of Wheat Flour Based on Neural Network Modelling

In order to quickly detect the adulteration of flour containing wheat flour quality testing, the Raman spectrum of wheat flour as the object of study, based on a number of data-based neural network to identify and determine the concentration of wheat adulteration. Firstly, the neural network system in this study borrowed the Raman wave number and Raman intensity curve from "Non-contact Detection of Benzoyl Peroxide in Flour Based on Raman Spectroscopy" as the training and testing set. Next, we created the neural network, set the training parameters, trained the network and simulated the test. Finally, the supervised learning process resulted in error analysis and comparison of results, and the Raman spectra of wheat flour and adulteration concentration were plotted visually.