Non-inflammatory Lesions Research Articles

Efficacy of IPL therapy for the treatment of acne vulgaris: A meta-analysis.

Intense pulse light (IPL) has been adopted by numerous patients. However, no existing study has analyzed the efficiency and safety of IPL in the treatment of acne vulgaris. To assess the efficiency and safety of IPL in the treatment of acne vulgaris. Electronic databases, including Embase, Cochrane Library, and MEDLINE, were retrieved to identify related studies. In this study, the primary and secondary outcomes were the mean percentage reduction of inflammatory acne lesion improvement (MPRI) and the mean percentage reduction of noninflammatory acne lesion improvement (NMPRI), respectively. Between-study heterogeneities were assessed using theI2 statistic. Eight randomized controlled trials (RCTs) including 450 patients were enrolled into the present analysis. With regard to MPRI, the result of IPL group was poorer than that of control group [mean deviation (MD)=-4.37 (95% confidence interval CI: -7.83, -0.91), P=.01]. In addition, the efficiency of IPL was poor among African and Asian populations [MD=-3.87 (95% CI: -7.36, -0.37), P=.03; MD=-28.37 (95% CI: -52.26, -4.18), P=.02]. Meanwhile, difference in the efficiency between IPL and 1064nm Nd:YAG was not statistically significant [MD=-3.25 (95% CI: -7.01, -0.51). P=.09]. Besides, the efficiency of IPL was lower than that of PDL [MD=-28.37 (95% CI: -52.26, -4.18), P=.02]. There was no statistically significant difference in the efficiency between IPL and other treatments for NMPRI. With regard to adverse effects, erythema (46.73%) and pain (39.13%) were the most common. IPL is not so efficient as other supplementary therapies. For inflammatory acne lesions, the efficiency of IPL is poorer than that of PDT. Difference in geographic regions may affect the IPL efficiency. However, the results obtained in this study should be cautiously interpreted due to the heterogeneities and the lack of studies with a large sample size.

Evaluation of Efficacy and Safety of AHPL/AYCAP/0413 Capsule and AHPL/ AYTOP/0213 Cream in Patients Suffering from Acne Vulgaris

Background: Available treatments for acne vulgaris are associated with various adverse effects, which necessitate patients to opt for alternative treatment options. Objectives: To evaluate efficacy and safety of AHPL/AYCAP/0413 capsule and AHPL/AYTOP/0213 cream in subjects suffering from Acne Vulgaris. Method: A total of 62 subjects completed the study. Subjects were advised to take 2 capsules of AHPL/AYCAP/0413 twice daily orally after meals with water and apply AHPL/AYTOP/0213 cream all over the face twice a day for two months or complete resolution of acne whichever was earlier. The primary objective was to assess changes in total number of inflammatory acne lesions on face. Secondary objectives were to assess changes in total numbers of noninflammatory acne lesions, total lesion count (inflammatory and non-inflammatory), acne severity, acne scarring, signs and symptoms, skin lightening effect, post acne dark spots, adverse events and laboratory investigations. Results: The mean inflammatory acne lesion count reduced significantly from 7.94 ± 5.91 (baseline visit) to 1.89 ± 3.06 (p=0.001) at the end of treatment. Significant reduction in total numbers of non-inflammatory acne lesions, total lesion count, acne severity and signs and symptoms of acne were observed at the end of treatment. Also improvement in skin colour, severity of post acne dark spot and reduction in numbers of post acne dark spots were observed at the end of treatment. Laboratory parameters were within normal limits both at pre and post treatment. Conclusion: AHPL/AYCAP/0413 capsule and AHPL/AYTOP/0213 cream is safe and significantly effective for treatment of acne vulgaris.

Once-Daily Polymeric Tazarotene 0.045% Lotion for Moderate-to-Severe Acne: Pooled Phase 3 Analysis by Sex.

Background: Two identical phase 3 randomized, double-blind, vehicle-controlled, 12-week studies (NCT03168321 and NCT03168334) demonstrated the efficacy and safety of tazarotene 0.045% lotion in participants with moderate-to-severe acne. Data from these studies were pooled and analyzed post hoc to evaluate outcomes by sex. Methods: Patients aged ≥9 years with moderate-to-severe acne (score 3 or 4 on the Evaluator's Global Severity Score [EGSS]) were randomized (1:1) to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Outcomes comprised inflammatory/noninflammatory lesion counts, treatment success (proportion of participants achieving ≥2-grade reduction from baseline in EGSS and score of 0 [“clear”] or 1 [“almost clear”]), and treatment-emergent adverse events (TEAEs). Results: A total of 1,064 females and 550 males were included in this analysis. For both sexes, least-squares mean percent changes from baseline to week 12 in lesion counts were significantly greater with tazarotene 0.045% lotion versus vehicle (inflammatory: females, -60.1% vs -52.1%; males, -53.6% vs -39.8%; noninflammatory: females, -57.6% vs -44.9%; males, -52.9% vs -36.5%; P<0.001, all). The percentage of participants achieving treatment success at week 12 was also significantly higher with tazarotene 0.045% lotion versus vehicle in females and males (P<0.001, both). Compared with tazarotene-treated males, tazarotene-treated females had significantly greater changes from baseline in inflammatory and noninflammatory lesions and a greater proportion achieved treatment success at week 12 (P<0.05, all). TEAE rates were similar between tazarotene- and vehicle-treated males; rates were higher for tazarotene-treated females than vehicle-treated females. Conclusions: Tazarotene 0.045% lotion was efficacious and well tolerated in the treatment of moderate-to-severe acne in female and male participants. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5249

Tolerability of tretinoin lotion 0.05% for moderate to severe acne vulgaris: a post hoc analysis in a black population.

Acne vulgaris (acne) is the most common dermatologic disorder seen in black patients. However, data are lacking on the effects of treatments, such as topical retinoids. Acne in black patients is frequently associated with postinflammatory hyperpigmentation (PIH), which can be of greater concern than the patient's acne and often is the main reason these patients seek a dermatologist consultation. Retinoids can treat both acne and PIH. However, the potential for retinoids to induce an irritant contact dermatitis, which could lead to PIH, is a concern. A lotion formulation of tretinoin was developed to provide an important alternative option to treat acne in black patients who may be sensitive to the irritant effects of other tretinoin formulations or where PIH is a concern.

Novel Polymeric Tazarotene 0.045% Lotion for Moderate-to-Severe Acne: Pooled Phase 3 Analysis by Race/Ethnicity

Background: Acne vulgaris and inflammation-associated sequelae are highly prevalent in black and Hispanic populations. In a phase 2 study, a novel polymeric emulsion formulation of tazarotene 0.045% lotion had relatively fewer adverse events than tazarotene 0.1% cream, but with comparable efficacy. The objective was to evaluate tazarotene 0.045% lotion by race and ethnicity in the pivotal trials. Methods: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants with moderate-to-severe acne were randomized 1:1 to tazarotene 0.045% lotion or vehicle lotion (N=1,614). This pooled, post hoc analysis included subsets of participants that self-identified as white (n=1191) or black (n=262) and Hispanic (n=352) or non-Hispanic (n=1262). Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment success (defined as at least a 2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 'clear' or 'almost clear'). Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were evaluated. Results: At week 12, tazarotene 0.045% lotion led to significantly greater percent reductions in inflammatory and noninflammatory lesions compared with vehicle in white, Hispanic, and non-Hispanic participants (P<0.05, all). Black participants had significantly greater reductions in noninflammatory lesions following treatment with tazarotene 0.045% versus vehicle (P<0.05). Treatment success rates in all subpopulations were higher with tazarotene 0.045% lotion (29.4-34.1%) versus vehicle (16.4-23.1%). TEAE rates were similar across tazarotene-treated groups and most were mild-to-moderate in severity. The incidence of hyperpigmentation decreased in black tazarotene-treated participants from baseline to week 12. Conclusions: Tazarotene 0.045% lotion demonstrated efficacy and was well tolerated across racial and ethnic subpopulations in this pooled analysis. J Drugs Dermatol. 2020;19(7) doi:10.36849/JDD.2020.5125.

Topical Minocycline Foam 4%: A Review in Acne Vulgaris.

Topical minocycline foam4% (Amzeeq™) is approved in the USA for the treatment of inflammatory lesions of non-nodular, moderate to severe acne vulgaris (acne) in patients aged ≥ 9years. It was developed to minimize systemic minocycline absorption and toxicity, and its high lipid content allows efficient drug movement through sebum and into affected sites. The favorable in vitro resistance profile of oral minocycline seen in Cutibacterium acnes (C. acnes) isolates was maintained with topical minocycline foam4%. In 12-week, phaseIII clinical trials, once-daily topical minocycline foam4% significantly improved both inflammatory and noninflammatory lesions relative to foam vehicle in patients aged ≥ 9years with moderate to severe acne and was reported by most patients to be satisfactory or highly satisfactory to use. Extension trial data indicated that topical minocycline foam4% continued to be effective for up to 52weeks' therapy. Topical minocycline foam4% was generally well tolerated in these patients, with most adverse events (AEs) and all serious AEs considered to be unrelated to treatment. Cutaneous AEs were uncommon, and findings from a dermal safety study showed that topical minocycline foam4% did not have any effects related to phototoxicity, photoallergy, skin sensitization and skin irritation. Topical minocycline foam 4% is thus a useful addition to available treatment options for the management of inflammatory lesions of non-nodular, moderate to severe acne in adult and pediatric patients aged ≥ 9 years.

New Polymeric Once-Daily Tazarotene 0.045% Lotion Formulation for Moderate-to-Severe Acne: Pooled Phase 3 Pediatric Analysis

Background: Acne vulgaris affects approximately 85% of adolescents. Topical tazarotene is efficacious and safe for acne treatment but irritation limits its use. The objective was to evaluate efficacy, safety, and tolerability of a new tazarotene 0.045% lotion formulation in patients aged 10-13 and 14-17 years with moderate-to-severe acne. Methods: In two phase 3, double-blind, vehicle-controlled 12-week studies, patients with moderate-to-severe acne (N=1,614) were randomized (1:1) to receive tazarotene 0.045% lotion or vehicle once-daily. Efficacy assessments included changes from baseline in inflammatory/noninflammatory lesions and treatment success (≥2-grade reduction in Evaluator's Global Severity Score [EGSS] and a clear/almost clear score). Quality of life (QoL) and adverse events (AEs) were also assessed. Results: Patients aged 10-13 years (n=136) and 14-17 years (n=548) were pooled. At week 12, mean percent reductions in inflammatory and noninflammatory lesion counts were significantly greater with tazarotene versus vehicle in both age groups (least-squares mean inflammatory 10-13 years: -55.6 vs -37.0%; 14-17 years: -53.3 vs -41.2%; noninflammatory 10-13 years: -47.7 vs -28.2%; 14-17 years: -52.7 vs -32.9%; P<0.01 all). More patients achieved treatment success with tazarotene versus vehicle in both age groups (P<0.05, both). There were no significant differences between tazarotene-treated age groups in lesion counts or treatment success. Acne-QoL scores at week 12 in both age groups were numerically improved in most domains with tazarotene 0.045% lotion versus vehicle. Most treatment-emergent AEs with tazarotene or vehicle were of mild or moderate severity in both age groups. Conclusions: Tazarotene 0.045% lotion was efficacious and well tolerated in pediatric patients with moderate-to-severe acne. J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.4959THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Prevalence and cutaneous comorbidities of hidradenitis suppurativa in the German working population

The association of hidradenitis suppurativa with other skin diseases has not yet been investigated in larger studies based on dermatological exams. The objectives of this study are to determine the prevalence and cutaneous comorbidities of hidradenitis suppurativa in the German working population. Between 2014 and 2017, 20,112 people in 343 German companies were examined for the presence of clinical features of hidradenitis suppurativa within the framework of a cross-sectional epidemiological study based on whole-body examinations. In addition, all cutaneous comorbidities were recorded. Point prevalence was calculated and the differences between individuals with and without hidradenitis suppurativa were determined by bivariate analysis. All statistical procedures were performed using SPSS 23.0 for Windows. Of 20,112 people examined, mean age was 43.6 ± 10.5 years; 52.3% were male. In total, n = 57 people (0.3%) with hidradenitis suppurativa were identified; 61.4% (n = 35) being male. In addition, non-inflammatory hidradenitis suppurativa-related lesions were found in 674 other individuals. In a bivariate comparison, patients with hidradenitis suppurativa showed significantly more frequently the following cutaneous comorbidities: acne vulgaris, psoriasis, seborrhoeic dermatitis, excoriations, and folliculitis. We determined a point prevalence of hidradenitis suppurativa of 0.3%. Since we have examined the working population, the healthy worker effect, which could have led to underestimation of prevalence, cannot be ruled out. The point prevalence of 0.3% for employed people in Germany and a prevalence of 3.0% for inflammatory and non-inflammatory hidradenitis suppurativa-related lesions show that hidradenitis suppurativa is an important disease for the whole health system.

Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne

Acne is a common, multifactorial skin condition, and treatments with novel mechanisms have been elusive. To assess the safety and efficacy of clascoterone cream, 1%, a novel topical androgen receptor inhibitor, in 2 phase 3 randomized clinical trials (CB-03-01/25 and CB-03-01/26). Two identical, multicenter, randomized, vehicle-controlled, double-blind, phase 3 studies conducted from November 2015 to April 2018 evaluated the efficacy and safety of use of clascoterone cream, 1%, in males and nonpregnant females 9 years and older with moderate or severe facial acne as scored on the Investigator's Global Assessment scale. Participants were enrolled if they had 30 to 75 inflammatory lesions and 30 to 100 noninflammatory lesions. Patients were randomized to treatment with clascoterone cream, 1%, or vehicle cream and applied approximately 1 g to the whole face twice daily for 12 weeks. Treatment success was defined as an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), and a 2-grade or greater improvement from baseline and absolute change from baseline in noninflammatory and inflammatory lesion counts at week 12. Safety measures included adverse event frequency and severity. A total of 1440 patients were randomzied in 2 studies. In CB-03-01/25, 353 participants were randomized to treatment with clascoterone cream, 1% (median [range] age, 18.0 [10-58] years; 221 [62.6%] female), and 355 participants were randomized to treatment with vehicle cream (median [range] age, 18.0 [9-50] years; 215 (60.6%) female); in CB-03-01/26, 369 participants were randomized to treatment with clascoterone cream, 1% (median [range] age, 18.0 [10-50] years; 243 [65.9%] female), and 363 participants were randomized to treatment with vehicle cream (median [range] age, 18.0 [range, 11-42] years; 221 [60.9%] female). At week 12, treatment success rates in CB-03-01/25 and CB-03-01/26 with clascoterone cream, 1%, were 18.4% (point estimate, 2.3; 95% CI, 1.4-3.8; P < .001) and 20.3% (point estimate, 3.7; 95% CI, 2.2-6.3; P < .001) vs 9.0% and 6.5% with vehicle, respectively. At week 12, in both CB-03-01/25 and CB-03-01/26, treatment with clascoterone cream, 1%, resulted in a significant reduction in absolute noninflammatory lesions from baseline to -19.4 (point estimate difference, -6.4; 95% CI, -10.3 to -2.6; P < .001) and -19.4 (point estimate difference, -8.6; 95% CI, -12.3 to -4.9; P < .001) vs -13.0 and -10.8 with vehicle, respectively, as well as a reduction in inflammatory lesions from baseline to -19.3 (point estimate difference, -3.8; 95% CI, -6.4 to -1.3; P < .001) and -20.0 (point estimate difference, -7.4; 95% CI, -9.8 to -5.1; P < .001) vs -15.5 and -12.6 with vehicle, respectively. Adverse events rates were low and mostly mild; the predominant local skin reaction was trace or mild erythema. Use of clascoterone cream, 1%, for acne treatment appears to demonstrate favorable efficacy and safety with low adverse event rates. ClinicalTrials.gov Identifiers: NCT02608450 and NCT02608476.

Efficacy of Adapalene 0.1% Versus Tretinoin 0.025% Cream as Treatment of Mild Acne Vulgaris

Abstract&#x0D; &#x0D; Introduction: Acne vulgaris (AV) is a chronic inflammatory of the pilosebaceous unit. Topical retinoid is a mainstay of mild AV first-line treatment.&#x0D; Aim of study: To assess the efficacy of topical retinoid for the treatment of mild AV.&#x0D; Method: The randomized double-blind clinical trial was conducted from June to September 2019 at Dr. Mohammad Hoesin General Hospital Palembang. A total of 70 mild AV patients who fulfilled inclusion criteria were enroled consecutively. Patients randomly treated with adapalene 0.1% cream or tretinoin 0.025% cream and evaluated every 2 weeks for 8 weeks to examine the number of AV lesion (inflammation, non-inflammation and total lesion).&#x0D; Result: There are reduction in number of inflammatory and non-inflammatory lesions at both groups but only inflammatory lesion was statistically significant (p &lt;0.05). Total lesions also decrease in adapalene and retinoin group (21.66 vs 5.75, 22.21 vs 7.96, respectively) and statistically significant (p &lt;0.05).&#x0D; Conclusion: Adapalen 0.1% cream showed non-inferiority to tretinoin 0.025% cream in efficacy, especially in the reduction of non-inflammatory and total lesions.

Potential of Trachyspermum ammi (ajwain) Gel for Treatment of Facial Acne vulgaris: a Pilot Study with Skin Biophysical Profile Assessment and Red Fluorescence Photography

Background and objectives: Acne vulgaris is one of the most common dermatologic conditions. The available anti-acne treatments are not satisfactory and safe. In this regard, searching for new treatments, especially natural materials with reasonable side effects and satisfactory effectiveness, could be promising. The aim of the present study was to explore the safety and efficacy of a topical formulation containing Trachyspermum ammi (ajwain) fruits essential oil in patients with facial acne. Methods: The essential oil of the fruits was extracted by hydrodistillation method and formulated as a 1% gel. In this open-labeled, uncontrolled clinical trial, 20 patients with mild to moderate acne received topical ajwain gel twice daily for 8 weeks. The outcomes of acne lesion count, red fluorescence parameters and biophysical skin profiles were evaluated at baseline, 4th and 8th weeks. Any adverse reaction was recorded during the study. Results: All patients completed the study. Two months after treatment, the mean reduction in the total (8.2±3.36; P=0.000) and non-inflammatory (7.3±4.53; p=0.000) lesions was statistically significant. Furthermore, a significant reduction in the size and quantity of red fluorescence spots was also observed. Biophysical skin profile measurements revealed a significant reduction in erythema (p=0.033) and sebum (p=0.026) and a significant increase in pH (p=0.005). No serious adverse events were reported. Conclusion: The results of this pilot study provided a basis for the effectiveness of topical ajwain gel for the treatment of mild to moderate facial acne. Conducting further double blind clinical trials are necessary to confirm the efficacy and safety of the product.

Clinical Assessment of New Topical Cream Containing Two Essential Oils Combined with Tretinoin in the Treatment of Acne.

BackgroundAcne is a frequent adolescent disease characterized by inflammatory and non-inflammatory lesions whose topical treatment very often presents adverse phenomena such as irritation or resistance to antibiotics that reduce the patient’s compliance. The purpose of this study is to compare a commercial product (Acnatac gel) based on clindamycin-tretinoin (CTG) with a galenic compound containing 2 essential oils (Myrtus communisL. and Origanum vulgare) and tretinoin (MOTC) to evaluate its anti-acne effectiveness and action on the microclimate of the skin.MethodsSixty volunteers were randomly divided into an A group using MOTC and a B group, as a positive control, using CTG. The effectiveness was assessed with non-invasive skin analysis (Sebumeter, pH meter, Tewameter and Mexameter) and the counts of the number of lesions, after 15 and 30 days.ResultsIn both groups, there is a worsening of transepidermal water loss (TEWL) due to tretinoin. MOTC has improved, starting from 15 days of treatment, the papular erythema (p = 0.0329 vs CTG) and has reduced at all times even the rashes of retinoids present in the healthy perilesional skin (p = 0.0329 and p = 0.0017, respectively, at 15 and 30 days).ConclusionMOTC has shown, compared to Acnatac, to have anti-acne efficacy and to possess an anti-inflammatory activity, due to essential oils, able to reduce in vivo erythematous lesions and those induced by retinoids.

CLINICOPATHOLOGICAL STUDY OF SALIVARY GLAND SWELLING

Introduction:&#x0D; Although the salivary, sweat, apocrine, and mammary glands all have similar phylogeny and cellular phenotypes, many lesions are unique to the salivary glands. Various studies around the world reported incidence for all salivary glands tumors to be between 0.4 and 13.5 cases/100,000. Salivary gland swellings can be broadly classified into inflammatory, non- inflammatory and neoplastic swellings. Acute inflammatory conditions generally can be diagnosed by history and physical examination alone, whereas chronic inflammatory diseases and granulomatous disorders require supplemental diagnostic information including lab tests, imaging studies and biopsy. Accurate pathological diagnosis is necessary for proper management of neoplastic disorders. In this part of the world, the problem of these tumours is more troublesome in management because of their late presentation due to poor economic condition and lack of awareness of health among the general population. It is important to note that diffuse swellings usually signify disease of inflammatory nature. Discrete swelling within the gland usually indicates neoplasia and rarely replace entire gland until very late. Submandibular gland tumours are twice as likely to be malignant, compared to parotid. Sublingual gland tumours are unusual, 80% are malignant. &#x0D; Material and Methods: Patients included were those admitted to surgical wards with salivary gland swellings due to obstructions of the salivary duct and neoplasia and were willing to participate in the study for investigation and treatment. Patients, hemoglobin level, bleeding time, clotting time, urine, sugar albumin, microscopy, chest screening, ECG, Blood urea, serum Creatinine, RBS was estimated. Specific investigations like FNAC, X-rays of Mandible were done for all patients in the study group. After evaluation of the swellings by clinical examination and by specific investigations, a surgical plan was formulated. The final decision was taken per operatively by the surgeon. The required specimen was sent for histopathologocal examinations. Different modalities of treatment adopted in this study were, surgery or surgery and post-operative radiotherapy.&#x0D; Results: Age of the patients varied from 9 years to 80 years. Average age of the patient was 40.6 years. Out of 40 cases 15(35%) cases was of male and 25(65%) cases of female. 62.5% (25 cases) were found in the parotid gland, 30% cases (12) in submandibular gland and 7.5% cases (3) in the sublingual gland. Out of 40 cases, neoplastic lesions of 65.0 %( 25 cases) and non-inflammatory non neoplastic lesions of 37.5% (15 cases) were seen. Out of 25 salivary gland&#x0D; Keywords: SALIVARY GLAND, TUMOUR, MALIGNANT, BENIGN, FNAC, HISTOPATHOLOGY

A study of effectiveness and safety of topical combination therapy for acne vulgaris patients in dermatology department of a tertiary care teaching hospital

Background: Acne vulgaris is a dermatological disorder characterised by formation of comedones and inflammatory lesions. Acne is one of the most common reason for visiting a dermatologist in early adulthood. The current line of management for mild to moderate acne is topical medications with antimicrobials and retinoids. The present study assessed the effectiveness and safety of topical combination therapy for mild to moderate acne vulgaris.Methods: An observational, prospective and comparative study conducted on newly diagnosed acne vulgaris patients who were treated with topical combination therapy. Changes in the total, inflammatory and non-inflammatory lesion counts, investigator global assessment (IGA) and dermatology life quality index (DLQI) scales were recorded to check effectiveness. Treatment emergent adverse events were recorded in suspected ADR reporting form for safety assessment.Results: Participants (n=97) were treated with three topical combination treatments either clindamycin-benzoyl peroxide (group-A), clindamycin-adapalene (group-B) or benzoyl peroxide-adapalene (group C). Majority of participants (42.3%) were treated with clindamycin-benzoyl peroxide group. Reduction from baseline of total, inflammatory and non-inflammatory lesion counts were highly significant within group comparison (p&lt;0.001), but between group differences were not significant. Significant improvement in DLQI and IGA scores were noted in all three groups, but between group comparison showed no significant differences. All three groups were safe and well tolerated and equally improve participant’s quality of life.Conclusions: all three topical combination drugs for mild acne vulgaris had similar effectiveness in terms of reduction in acne lesions with similar safety profile.

Evaluating FMX-101 as a promising therapeutic for the treatment of acne

ABSTRACT Introduction Oral minocycline is a mainstay of therapy for moderate-to-severe acne; however, systemic side effects which include hepatotoxicity, lupus-like syndrome, drug hypersensitivity syndrome, autoimmune hepatitis, polyarteritis nodosa, gastrointestinal side effects and skin hyperpigmentation are of concern. Topical antibiotics commonly used in acne, such as erythromycin and clindamycin, present high P. acnes resistance rates which has opened the market for new topical antibiotics. FMX-101 is a novel topical minocycline foam that has shown promising results in phase I, II and III trials for the treatment of moderate-to-severe acne with a better safety profile than oral minocycline. Areas covered The author provides an overview FMX-101 including its clinical efficacy and safety. The author then provides their expert opinion on this treatment and its potential for the treatment option for acne. Expert opinion The topical foam formulation of FMX-101 has been shown to reduce both inflammatory and non-inflammatory lesions and to improve IGA scores in patients with moderate-to-severe acne without significant systemic absorption thus limiting associated side effects. Overall, the proven efficacy and safety profile of FMX-101, together with the low systemic absorption, high skin tolerability and cosmetically acceptable foam formulations render this novel therapy an important addition to the acne treatment armamentarium.

Efficacy and safety comparison of combination of 0.04% tretinoin microspheres plus 1% clindamycin versus their monotherapy in patients with acne vulgaris: a phase 3, randomized, double-blind study

Background and objectives There is an unmet need for topical treatments with good tolerability in management of acne vulgaris. The present study aimed to evaluate efficacy and safety of a novel tretinoin (microsphere, 0.04%) formulation in combination with clindamycin (1%) gel for treatment of acne vulgaris. Materials and methods This phase 3 randomized, double-blind study included patients with moderate-to-severe acne. Patients were treated with tretinoin (microsphere, 0.04%) + clindamycin (1%) or one of the monotherapies (tretinoin, 0.025%; clindamycin, 1%). Key endpoints included percent change in lesion counts, and improvement in Investigator’s Static Global Assessment (ISGA) score. Results 750 patients were randomized (combination, n = 300; tretinoin and clindamycin, each n = 150). At week 12, reductions in inflammatory (77%), non-inflammatory (71%) and total lesions (73%) were significantly greater with combination treatment versus either monotherapy (p < .03). Proportion of patients rated ‘clear’ or ‘almost clear’ with ≥2-grade ISGA improvement was higher with combination (46%) versus monotherapies (p < .02). Adverse events occurred in 20 patients, most were mild-moderate; no deaths or serious adverse events were reported. The discontinuation rates due to adverse events with combination therapy were low (≤1%). Conclusion The once-daily, microsphere-based formulation was generally tolerable with a positive impact on therapeutic outcomes and patients’ compliance. ClinicalTrial Registration No. CTRI/2014/08/004830

Novel Polymeric Lotion Formulation of Once-Daily Tazarotene (0.045%) for Moderate-to-Severe Acne: Pooled Phase 3 Analysis.

Background: As current tazarotene formulations indicated for acne (0.1%) can cause irritation, a new tazarotene 0.045% lotion formu-lation was developed using polymeric emulsion technology. The objective was to assess efficacy, safety, and tolerability of tazarotene 0.045% lotion in patients with moderate-to-severe acne in a pooled analysis of data from two identical phase 3, double-blind, random-ized, vehicle-controlled 12-week clinical studies. Methods: Patients aged ≥9 years with moderate-to-severe acne were randomized (1:1) to tazarotene 0.045% lotion or vehicle lotion applied once daily. Inflammatory and noninflammatory lesion counts and Evaluator's Global Severity Score (EGSS) were assessed. Treatment success was defined as a ≥2-grade improvement in EGSS and a score of 'clear'/'almost clear'. Adverse events (AEs) and cutaneous safety and tolerability were also assessed. Results: In total, 1614 patients (mean age: 20.5 years) were randomized to tazarotene 0.045% lotion (n=799) or vehicle (n=815). At week 12, tazarotene 0.045% lotion demonstrated statistically significant superiority versus vehicle in reducing inflammatory and non-inflammatory lesion counts (least-squares mean percent changes from baseline: inflammatory, -57.9% vs -47.8% [P<0.001]; noninflam-matory, -56.0% vs -42.0% [P<0.001]). Treatment success at week 12 was also greater with tazarotene 0.045% lotion versus vehicle (30.4% vs 17.9%; P<0.001). The most frequent treatment-emergent AEs related to tazarotene treatment were application site pain (5.3%), dryness (3.6%), and exfoliation (2.1%). Conclusions: The new tazarotene 0.045% lotion formulated with polymeric emulsion technology demonstrated statistically signifi-cantly superior efficacy versus vehicle and was well tolerated in pediatric and adult patients with moderate-to-severe acne in this pooled analysis of 2 vehicle-controlled phase 3 studies. J Drugs Dermatol. 2020;19(3):272-279. doi:10.36849/JDD.2020.4869.

Cosm-nutraceutical nanovesicles for acne treatment: Physicochemical characterization and exploratory clinical experimentation

The full exploration of the 'nutraceuticals' therapeutic potential in cosmetics has been hindered by their poor stratum corneum permeation. Therefore, the aim of the present study was to formulate a nutraceutical; quercetin, in novel vitamin C based nanovesicles (aspasomes), and to explore their beneficial effects in the treatment of acne. Aspasomes were characterized for their particle size, zeta potential, entrapment efficiency (EE%), 3-months storage stability, skin deposition/permeation, antioxidant potential, and morphology. Aspasomes antibacterial efficacy on Propionibacterium acnes using the zone of inhibition assay was also tested, whilst their safety on skin fibroblastic cells was assessed in vitro using 3T3 CCL92 cell lines. An exploratory clinical trial was conducted in acne patients, and the percentage reduction of inflammatory, non-inflammatory and total acne lesions was taken as the evaluation criterion. Results revealed that quercetin-loaded aspasomes displayed a desirable nanometer size (125-184nm), negative charge with good storage stability, and high skin deposition reaching 40%. Aspasomes managed to preserve the antioxidant activity of quercetin, and exhibited a significantly higher antibacterial effect (15±1.53mm) against Propionibacterium acnes than quercetin alone (8.25±2.08mm), and were safe on skin fibroblastic cells. Upon clinical examination in 20 acne patients (14 females, 6 males), quercetin aspasomes exhibited reduction percentages of 77.9%, 11.8% and 55.3% for inflammatory lesions, comedones and total lesions respectively. This opens vast applications of the presented formulation in the treatment of other oxidative skin diseases, and delineates the nutraceuticals and nanoformulations prepared from natural materials as promising dermatological treatment modes.

A split-face comparison of a fractional microneedle radiofrequency device and fractional radiofrequency therapy for moderate-to-severe acne vulgaris.

Radiofrequency equipment, including invasive fractional microneedle radiofrequency (FMR) and noninvasive fractional radiofrequency (FR), has facilitated progress in the field of active acne treatment, but clinical data are limited. This study aimed to compare the efficacy and safety of FMR and FR in the treatment of moderate-to-severe acne vulgaris. Ten patients with moderate-to-severe acne were enrolled in a 24-week, prospective, single-blind, randomized, comparative clinical trial with a split-face design. Fractional microneedle radiofrequency treatment was provided on one side of the face and FR on the opposite side. Three consecutive treatments were performed at 4-week interval. Objective assessment of efficacy was performed using the Acne Severity Index (ASI), and acne inflammatory lesions and noninflammatory lesions were evaluated. After the first treatment, ASI and both inflammatory and noninflammatory lesions of the FMR-treated side were improved to a greater degree than the FR-treated side. Patients' subjective satisfaction was also better regarding the FMR-treated side. After subsequent treatments, efficacy improves for both groups, and no significant differences in the above efficacy parameters between the two groups were observed. Pain scores were significantly higher for the FR-treated side than the FMR-treated side. Fractional microneedle radiofrequency is faster and more effective than FR for the treatment of moderate and severe acne after only one treatment. However, after several treatment sessions, both FMR and FR proved to be safe and effective for long-term treatment of moderate-to-severe acne. Therefore, invasive radiofrequency, such as FMR, or noninvasive radiofrequency, such as FR, can successfully treat active acne.

A Correlation between Serum Level of Alkaline Phosphatase and Acne Severity in Children and Adolescents: A Retrospective Cross-Sectional Study.

BackgroundAcne is a chronic inflammatory disease of the pilosebaceous unit and usually affects adolescents when the peak concentrations of growth hormone, insulin-like growth factor 1, and androgen are demonstrated. The activity of alkaline phosphatase (ALP), which increases physiologically in growing children and adolescents, in the pilosebaceous unit has been reported. However, the correlation between the serum level of ALP and the number of acne lesions has not been studied.ObjectiveThe present cross-sectional study was designed to evaluate the correlation between serum level of ALP and the numbers of non-inflammatory and inflammatory acne lesions in children and adolescents.MethodsFor this study, 202 pediatric and adolescent patients clinically diagnosed with acne vulgaris were included. Age, sex, serum level of ALP, number of non-inflammatory acne lesions, number of inflammatory acne lesions, and number of total acne lesions were evaluated. Additionally, the serum level of dehydroepiandrosterone sulfate was evaluated in 117 patients. Multiple regression analysis was performed. Multicollinearity was quantified using the variance inflation factor.ResultsIn the 202 patients, serum level of ALP was the only independent factor that significantly affected both the number of non-inflammatory acne lesions and of total acne lesions (regression coefficient=0.089 and 0.086, respectively, p<0.001).ConclusionThere was a significant correlation between serum level of ALP and the extent of acne (non-inflammatory acne lesions and total acne lesions).