Topical Salbutamol Cutaneous Gel Is Safe in a Double-Blind, Placebo-Controlled, Randomized Trial of Scarring from Sutured Wound Margins on the Arms of Healthy Human Volunteers

Aloe Kanti, a natural anti-aging gel, modulates exogenous insult- and aging-induced aberrations in keratinocytes, dermal fibroblasts, melanocytes, and protects Caenorhabditis elegans from UVB photoaging.

Introduction: Inflammation and oxidative stress play key roles in the pathogenesis of various musculoskeletal and soft tissue disorders. Conventional pharmacologic therapies, such as Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), are associated with several adverse effects, prompting interest in safer, biologically active alternatives. Trypsin and bromelain are proteolytic enzymes known for their anti-inflammatory activity, while rutoside exhibits potent antioxidant and vascular protective properties. Glucosamine, commonly used for joint health, contributes to cartilage repair and has shown mild anti-inflammatory effects. The combination of these agents in a topical gel formulation may offer synergistic benefits in managing inflammation and oxidative stress locally. Aim: The present study examined the anti-inflammatory and antioxidant properties of trypsin, bromelain, rutoside, and glucosamine combination. Materials and Methods: The present in-vitro study was conducted at Gold lab, Department of Pharmacology, Saveetha Dental College and Hospital, Chennai, Tamil Nadu, India, from January to August 2024. The chemicals involved in the process were sourced from SISCO Research Laboratories private limited. The active pharmacological ingredients like trypsin, bromelain, rutoside and glucosamine were mixed and tested. The anti-inflammatory and antioxidant properties of both the formulations were investigated. Albumin denaturation assay for anti-inflammatory activity and 1,1-Diphenyl-2-Picrylhydrazyl (DPPH) assay for antioxidant activity were performed. Student t-test was performed to determine the significance, where p-value less than 0.05 were considered statistically significant. Results: The combination gel exhibited a dose-dependent increase in both anti-inflammatory and antioxidant activities. Anti-inflammatory activity, assessed via the albumin denaturation assay, increased from 51.74% at 20 µg/mL to 85.02% at 100 µg/ mL, closely approaching the inhibition shown by the standard drug diclofenac sodium (94.53%). Similarly, in the DPPH assay, antioxidant activity rose from 41.26% at 20 µg/mL to 95.98% at 100 µg/mL, surpassing the activity of ascorbic acid (86.86%) at the highest concentration. Statistical analysis confirmed that these increases were highly significant (p<0.05). Conclusion: The in-vitro findings demonstrated that the trypsin, bromelain, rutoside, and glucosamine combination gel possessed strong, concentration-dependent anti-inflammatory and antioxidant properties. These results suggest its potential as a topical therapeutic alternative to conventional NSAIDs for localised treatment of musculoskeletal and inflammatory conditions. Further in-vivo and clinical studies are recommended to validate its safety, efficacy, and therapeutic applicability

Introduction: Inflammation and oxidative stress play key roles in the pathogenesis of various musculoskeletal and soft tissue disorders. Conventional pharmacologic therapies, such as Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), are associated with several adverse effects, prompting interest in safer, biologically active alternatives. Trypsin and bromelain are proteolytic enzymes known for their anti-inflammatory activity, while rutoside exhibits potent antioxidant and vascular protective properties. Glucosamine, commonly used for joint health, contributes to cartilage repair and has shown mild anti-inflammatory effects. The combination of these agents in a topical gel formulation may offer synergistic benefits in managing inflammation and oxidative stress locally. Aim: The present study examined the anti-inflammatory and antioxidant properties of trypsin, bromelain, rutoside, and glucosamine combination. Materials and Methods: The present in-vitro study was conducted at Gold lab, Department of Pharmacology, Saveetha Dental College and Hospital, Chennai, Tamil Nadu, India, from January to August 2024. The chemicals involved in the process were sourced from SISCO Research Laboratories private limited. The active pharmacological ingredients like trypsin, bromelain, rutoside and glucosamine were mixed and tested. The anti-inflammatory and antioxidant properties of both the formulations were investigated. Albumin denaturation assay for anti-inflammatory activity and 1,1-Diphenyl-2-Picrylhydrazyl (DPPH) assay for antioxidant activity were performed. Student t-test was performed to determine the significance, where p-value less than 0.05 were considered statistically significant. Results: The combination gel exhibited a dose-dependent increase in both anti-inflammatory and antioxidant activities. Anti-inflammatory activity, assessed via the albumin denaturation assay, increased from 51.74% at 20 µg/mL to 85.02% at 100 µg/ mL, closely approaching the inhibition shown by the standard drug diclofenac sodium (94.53%). Similarly, in the DPPH assay, antioxidant activity rose from 41.26% at 20 µg/mL to 95.98% at 100 µg/mL, surpassing the activity of ascorbic acid (86.86%) at the highest concentration. Statistical analysis confirmed that these increases were highly significant (p<0.05). Conclusion: The in-vitro findings demonstrated that the trypsin, bromelain, rutoside, and glucosamine combination gel possessed strong, concentration-dependent anti-inflammatory and antioxidant properties. These results suggest its potential as a topical therapeutic alternative to conventional NSAIDs for localised treatment of musculoskeletal and inflammatory conditions. Further in-vivo and clinical studies are recommended to validate its safety, efficacy, and therapeutic applicability

Skin-derived precursors (SKPs) isolated from the dermis are poorly immunogenic and capable of modulating the allogeneic immune responses. Previous studies implied mouse SKPs-derived exosomes (mSKPs-exo) might possess immunomodulatory functions. In the present study we collected mSKPs-exo using ultracentrifugation method and characterized them. We then explored mSKPs-exo's impact on acne inflammation with Cutibacterium acnes (C. acnes)-challenged murine monocyte-macrophages RAW264.7 and Sprague Dawley (SD) rats auricular acne model. The invitro studies demonstrated mSKPs-exo reduced nitric oxide, TNF-α, and IL-6 concentration in C. acnes-challenged RAW264.7 cells supernatant. mSKPs-exo also ameliorated NF-κB p65 nuclear translocation and CD86 and iNOS antigens expression in C. acnes-challenged RAW264.7 cells. The RT-PCR and Western blots revealed mSKPs-exo alleviated inflammation by regulating key genes (TLR2, TNF-α, MyD88, and IL-6) and proteins (TLR2, MyD88, IκBa, and NF-κBp65) in the TLR2/MyD88/NF-κB pathway. The anti-inflammatory effects could be synergistically enhanced by IκB/IKK inhibitor. The invivo studies validated mSKPs-exo's efficacy on acne inflammation and TLR2/MyD88/NF-κB pathway. Topical dermal injection of mSKPs-exo alleviated auricular inflammatory manifestations in SD rats. Immunohistochemistry and Western blot results indicated mSKPs-exo reduced the expression of TLR2, MyD88, MMP3, p-p38 MAPK, and NF-κB p65. The effect was comparable with topical adapalene gel application. The current study initiated mSKPs-exo research and provided theoretical support and experimental data for their potential application in inflammation regulation, acne treatment, and novel therapeutic targets identification.

The current study focuses on the creation and evaluation of a topical gel that contains the nonsteroidal anti-inflammatory medication (NSAID) naproxen, a pain reliever. Carbopol and propylene glycol were used as gelling agents to guarantee the gel's strength and as penetration enhancers to promote absorption into the skin. Physical attributes like viscosity, pH, and appearance were evaluated. Studies on skin penetration revealed effective absorption, whereas experiments using a flow-through diffusion cell showed a protracted release profile. Stability testing verified that the gel retained its properties in a range of circumstances. The results indicate that this transdermal gel formulation presents a feasible substitute for administering naproxen, improving patient compliance via non-invasive delivery. To confirm the therapeutic effectiveness and safety of this technique, more in vivo research is advised.

Background: Although Morus alba (white mulberry) has long been used in traditional skin care, the scientific evidence for its leaf extract in anti-hyperpigmentation applications remains limited, particularly regarding its incorporation into topical formulations. This study investigated the melanin-synthesis-inhibitory, tyrosinase-inhibitory, and antioxidant activities of M. alba leaf extract and evaluated its potential in a stable topical gel formulation. Methodology: Melanin suppression was assessed in IBMX-stimulated B16F10 melanocytes using microscopic observation, pellet analysis, and quantitative melanin measurement. Tyrosinase inhibition was examined with a mushroom tyrosinase assay, while antioxidant capacity was evaluated via DPPH radical scavenging. A topical gel containing M. alba extract was developed and assessed for physicochemical properties, phenolic retention, bioactivity, and stability. Result and Discussion: The extract showed strong tyrosinase inhibition (IC₅₀ = 5.70 ± 0.28 µg/mL) and antioxidant activity (IC₅₀ = 16.22 ± 0.6 µg/mL), and significantly reduced melanin synthesis in B16F10 cells without cytotoxicity (≤ 200 µg/mL). The formulated gel maintained phenolic content, exhibited moderate tyrosinase inhibition, and demonstrated stable appearance, pH, spreadability, and bioactivity during storage. Conclusion: Morus alba leaf extract possesses potent anti-melanogenic and antioxidant properties and can be successfully incorporated into a stable topical gel, supporting its potential as a natural ingredient for anti-hyperpigmentation products. However, these findings are based on in vitro assays and preliminary formulation studies; further in vivo and clinical evaluations are needed to confirm its efficacy and safety in humans.

Rosacea is a chronic inflammatory dermatosis mainly affecting the cheeks, nose, chin, and forehead. It is characterized by recurrent episodes of flushing, persistent erythema, phymatous changes, papules, pustules, and telangiectasia. Granulomatous rosacea (GR) is an uncommon variant of rosacea characterized by persistent erythema and papules usually seen in middle age women. Histopathology of GR shows granulomas in upper dermis and has a delayed therapeutic response compared to other types of rosacea. We report an atypical case of GR in a 19-year-old male. A 19-year-old male who presented with reddish dry raised lesions around mouth and nose of 3 months duration. On clinical examination diffuse shiny infiltrated plaques with ill-defined margins were seen over perioral region extending to nasolabial folds, lower forehead including glabellar region. Differential diagnosis of Granulomatous rosacea, Seborrheic dermatitis, Follicular mucinosis, Plaque sarcoidosis was considered. Histopathology showed normal epidermis, interstitial granulomatous infiltrate composed of epithelioid histiocytes, langhans giant cells, lymphocytes suggestive of GR. Patient was treated with oral minocycline 65 mg/day, broad spectrum sunscreen lotion, topical clindamycin gel daily night along with topical ivermectin once weekly resulting in marked clinical improvement after 8 weeks. Classical presentation of GR shows yellowish brown, red papules over cheeks, periorificial regions healing with scar formation. The present case had atypical clinical features presenting with infiltrated and well marginated plaques over multiple facial regions which was confirmed by histopathology and responded satisfactorily to the treatment.

Ultraviolet-B (UV-B) exposure can trigger inflammation and inhibit skin regeneration by decreasing Platelet-Derived Growth Factor (PDGF) and increasing Interleukin-6 (IL-6). Butterfly Pea (Clitoria ternatea L.) is known for its antioxidant and anti-inflammatory properties, but its effectiveness as a topical gel has not been widely studied. This study aims to evaluate the effect of Butterfly Pea (Clitoria ternatea L) extract gel on IL-6 and PDGF expression in Wistar rats exposed to UVB. This study is an in vivo experimental study with a post-test-only control group design. A total of 20 Wistar rats (200–250 g) were divided into four groups consisting of 5 rats per group: K1 (healthy control), K2 (gel base + UV-B), K3 (5% Clitoria ternatea gel + UV-B), and K4 (10% Clitoria ternatea gel + UV-B). UV-B exposure was carried out for 20 minutes/day (160 mJ/cm²) for 7 days. PDGF and IL-6 expression were analyzed by RT-qPCR. Statistical tests using Shapiro-Wilk, Levene, Kruskal-Wallis for PDGF expression, and One-Way ANOVA for IL-6 expression. Studies have shown that PDGF expression did not show significant differences between groups (p=0.455), with an average expression of K1: 1.39±0.62, K2: 1.39±0.61, K3: 1.66±0.87, and K4: 1.52±1.88. IL-6 expression was also similar (p=0.663), an average of K1: 1.02±0.18, K2: 1.11±0.33, K3: 1.22±0.23, and K4: 1.16±0.26. Conclusion: Administration of Clitoria ternatea L. extract gel did not have a significant effect on PDGF and IL-6 expression in the skin of Wistar rats exposed to UVB light. Both 5% and 10% doses showed no significant difference in the expression of the two markers; further studies with larger sample sizes, longer treatment durations, and improved topical delivery systems are needed. are recommended to better evaluate its therapeutic potential.

Abstract Introduction MED3000 is an FDA-cleared, over-the-counter topical gel for erectile dysfunction (ED), offering a non-systemic alternative to pharmacologic therapies. Understanding its efficacy across varying ED durations is important for guiding clinical use. Objective To evaluate the efficacy of MED3000 in men with differing durations of ED using the International Index of Erectile Function – Erectile Function (IIEF-EF) domain scores. Methods Data were pooled from two multi-center, randomized clinical trials that enrolled men diagnosed with ED for >3 months. One trial lasted 12 weeks and the other 24 weeks. Participants were instructed to apply MED3000 before intercourse and attempt ≥4 sexual encounters per 4-week interval. IIEF-EF domain scores were collected at baseline and at 4, 8, and 12 weeks. Subjects were stratified by ED duration: <6 months, 6 to 12 months, 12 to 18 months, 18 to 24 months, and >24 months. A linear mixed effects model evaluated changes from baseline with fixed effects for ED duration subgroup, visit number, baseline (BL) IIEF-EF domain score, and repeated measures collected at each visit for each subject. Estimated marginal mean differences between BL and each treatment time point are reported, including the mean difference, standard error (SE), and the respective p-value. The proportion of men achieving ≥4-point improvement in IIEF-EF at week 12 by ED duration subgroup was analyzed by Chi-square test. Results The analysis included a modified intent-to-treat population of 290 subjects with 15.9%, 25.2%, 14.5%, 13.4%, and 31.0% having ED durations of <6 months, 6 to 12 months, 12 to 18 months, 18 to 24 months, and >24 months, respectively. There was a significant improvement from BL at 4, 8, and 12 weeks (all p<0.0001) for all ED duration subgroups at each timepoint (Table 1). With one exception, there were no significant differences in efficacy for any ED duration subgroup versus those with a duration >24 months at any time point (Table 1). Percentages of patients with a >4-point improvement in IIEF-EF domain scores also were comparable across groups (p=0.7162). Conclusions Topical MED3000 significantly improves erectile function across a wide range of ED durations. Its consistent efficacy supports its utility as an accessible, non-prescription, first-line treatment for men with ED, including those with longer-standing disease. Disclosure Yes, this is sponsored by industry/sponsor: Haleon Clarification: Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Haleon

Abstract Introduction Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD) is a rare and distressing condition characterized by unwanted genital arousal without associated sexual desire. While cases of PGAD/GPD caused by interstitial cystitis, urethritis, and urethral diverticulum have been described, PGAD/GPD secondary to bladder cancer has not yet been reported. As cases of young female patients without a significant family history of bladder cancer or smoking history are rare, the clinical presentation of these cases may not be well defined in the literature. Objective To describe the first known case of PGAD/GPD as the initial presentation of low-grade papillary urothelial carcinoma of the bladder in a young female. Methods This was a case report using retrospective chart review, a structured one-on-one interview, and validated measures to quantify PGAD/GPD-related distress and catastrophizing. Results A 26 year old healthy female presented with a three month history of constant, distressing clitoral throbbing and pain in her vulvar vestibule that began during masturbation. She also noted dysuria, urinary frequency, urgency, intermittent hematuria, and nocturia 2-3 times per night. She was displaying clinically relevant, distressing PGAD/GPD symptoms, scoring 60 out of 60 on the Persistent Genital Arousal Sensations Questionnaire (PGASQ) and 47 out of 52 on the Pain-Catastrophizing Scale (PCS). She denied any smoking history but did report a history of resin exposure in her career as an artist. She had been seen by psychotherapy, received topical lidocaine, and underwent pelvic floor physical therapy (PFPT) without relief. A urologist attempted a clitoral stretching procedure and recommended a clitoridectomy. After seeking a second opinion, she underwent a bladder ultrasound which revealed a 7 x 5 x 6 mm nonmobile lesion in the left posterior bladder wall, lateral to the ureteral orifice. Cystoscopy and pathology revealed low grade papillary (Ta) urothelial carcinoma of the bladder and trans-urethral resection of bladder tumor was performed. Symptoms had completely resolved three months after the procedure with continued use of topical lidocaine gel and PFPT. Two years later she underwent cystoscopy to evaluate recurrence of genitourinary symptoms and was found to have a large amount of squamous metaplasia in the left trigone on cystoscopy. After fulguration she continued to experience symptoms and was treated with one course of nitrofurantoin despite negative urine culture, after which her symptoms again resolved. At the time of writing, the patient is no longer displaying clinically relevant, distressing PGAD/GPD symptoms, scoring 18 out of 60 on the PGASQ and 19 out of 52 on the PCS. Conclusions This is the first known instance of bladder cancer diagnosis following presentation with PGAD/GPD. The proposed hypothesis involves stimulation of the pelvic nerves with subsequent crossed-central sensitization at the level of the sacral plexus sending efferent signals to both the pelvic nerve causing irritative voiding symptoms, and to the pudendal nerve causing clitoral and vestibular dysesthesia. Secondary hypertonic pelvic floor dysfunction may exacerbate symptoms. Further investigation is warranted to better understand the relationship between bladder tumors and PGAD/GPD. Disclosure No

Abstract Introduction Erectile dysfunction (ED) is prevalent in adult men, and while prescription drugs like sildenafil and tadalafil dominate treatment, interest in over-the-counter (OTC) options is growing. The recent FDA clearance of Eroxon, a topical ED gel, highlights this shift. Objective This study aims to explore the current landscape of OTC drug options available to U.S. consumers for the treatment of ED. Methods A review of sources like Drugs.com and DailyMed shows limited OTC availability. Drugs.com lists only prescription ED meds, while DailyMed identifies a few unregulated homeopathic OTC products. Major U.S. pharmacies mainly offer prescriptions, with Eroxon standing out as the only FDA-cleared OTC ED treatment. Some supplements-like L-arginine, DHEA, and ginseng-are marketed for sexual health but lack FDA evaluation. Results Viagra Connect® is available OTC in the UK, providing a noteworthy contrast to the U.S. market. Ongoing U.S. trials, like Opella, are exploring making tadalafil available without a prescription. Telehealth platforms such as hims and GoodRx Care are reshaping ED care by offering accessible, subscription-based prescription services. In 2023, 25% of Medicare beneficiaries utilized telehealth, reflecting growing demand for convenient treatment options. Conclusions While the market remains predominantly prescription-based, the increasing role of telemedicine and the gradual introduction of OTC products abroad suggest that future developments in the U.S. could shift the landscape of ED treatment. Further research is needed to explore the safety, efficacy, and regulatory status of these emerging alternatives Disclosure No

Dental home care of pets plays a critical role in preventing periodontal disease. Active methods of dental home care such as tooth brushing are recommended along with oral hygiene measures that can help reduce dental plaque. The study evaluated the effectiveness of a new topical oral gel (TOG) in controlling plaque accumulation in dogs. After scaling and polishing, 32 dogs were randomly assigned to either a control group with no further oral hygiene care or the TOG group that received an application of the oral gel once a day for 30 days. All dogs were fed the same diet during the trial. Five parameters were evaluated in 9 target teeth on days 0 and 30: periodontal disease index (PDI), calculus index (CI), gingival bleeding index (GBI), plaque index, and oral health index (OHI). On day 30, comparison between the groups showed no differences for PDI and CI. However, OHI, PDI, and GBI were significantly lower in the TOG group (P < .05). Furthermore, OHI and GBI decreased over time in the TOG group (P < .05) and not in the control group. These results show that once-daily oral applications of TOG, without mechanical action, reduced the accumulation of dental plaque in dogs.

Background. The usage of topical androgens has become increasingly popular in recent years due to their availability and ease of use at home. However, a lack of awareness about the precautions to be taken when using topical gels can lead to unintended secondary exposure of third parties, including the risk of developing exogenous hyperandrogenism in children. Case Reports describe 5 patients (3 boys and 2 girls) who were examined for signs of precocious sexual development (PSD): pubic hair, enlargement of the penis or clitoris, accelerated growth, and advanced bone age. All patients showed isolated increases in blood testosterone levels, low values of gonadotropic hormones, and other indicators of the steroid profile. During a repeated proactive survey of parents, it was revealed that the patients’ fathers were using transdermal forms of testosterone and were not following the precautions to avoid exposing their children to these products. After eliminating the exogenous exposure to androgen, all patients’ blood testosterone levels returned to prepubertal levels. During follow-up, two patients developed gonadotropin-dependent PSD, necessitating the initiation of triptorelin therapy. Conclusion. These case reports highlight the need for increased awareness among physicians and patients of the potential risk of developing exogenous hyperandrogenism in children with unintentional exposure to transdermal androgens as a result of parental or guardian use of these medications and, consequently, the importance of taking precautions. Thorough collection of family and social history in children with signs of precocious puberty is essential in the timely diagnosis of an exogenous cause of hyperandrogenism and in the selection of examination and treatment.

Abstract: Inflammation is a body defense response to antigen exposure, infection, cell damage, allergens, irritants, and injury. The antibacterial activity of babadotan leaves can prevent inflammation due to microbial infections. This study aims to create and evaluate a topical gel preparation containing babadotan leaf extract (Ageratum conyzoides L.) as an anti-inflammatory agent. Babadotan leaf extract was obtained through a maceration method using 96% ethanol. The resulting gel preparation was then evaluated through various tests, including homogeneity, organoleptic properties, adhesiveness, spreadability, pH, and viscosity. The results of the study obtained a homogeneity test for all gel formulas were uniform. The organoleptic results of the gel had a distinctive odor of babadotan leaves, a thick, slightly sticky texture. The spreadability test found a range of 5.5-6.6 cm where the gel had good consistency. The adhesiveness test met the requirements of F1 5 seconds; F2 6 seconds; F3 9 seconds. The pH test F1 6.2; F2 6.0; F3 5.8. And the viscosity test F1 8.431 mPa·s; F2 8.604 mPa·s; F3 8.792 mPa·s, for aroma, F1 and F2 received a positive response (70–90% of panelists liked it). The conclusion is that the gel preparation containing babadotan leaf extract has good physical properties and shows stability during storage under various conditions.

Socket preservation (SP) with bone grafting is often used to maintain alveolar ridge dimensions following tooth extraction. However, healing in compromised patients, such as tobacco smokers and patients with type 2 diabetes mellitus (DM), is compromised. Oxygen-releasing hydrogels have emerged as potential adjuncts to enhance osseous healing by improving angiogenesis and osteogenesis. This case report presents 6-month follow-up clinical results of SP using an oxygen-releasing hydrogel dressing in a male smoker with type 2 DM. A 51-year-old male habitual cigarette smoker with a history of type-2 DM presented for the replacement of a grossly carious left maxillary second premolar. Following atraumatic extraction, the socket was irrigated with an oxygen-enriched solution and treated with a topical oxygen-releasing gel before bone grafting with a corticocancellous allograft mixed with the gel. The site was sutured with resorbable sutures, and the healing process was monitored at 2 weeks and 6 months. Clinical and radiographic evaluations were conducted to assess bone regeneration before implant placement. Healing was uneventful, and at the 6-month follow-up, a bone-level dental implant was successfully placed with adequate primary stability. The application of a topical oxygen-rich gel during SP appears to facilitate osseous healing; however, further power-adjusted, long-term randomized controlled trials and histologic investigations are needed to confirm this relationship.

Discovery of FBP1 as novel therapeutic target and asiatic acid-hydrogen sulfide donors accelerate diabetic wound healing.

Diphenyl carbonate crosslinked β-cyclodextrin nanosponge-based topically applied gel for co-delivery of baricitinib and tenoxicam in rheumatoid arthritis.

Barrier gel formulations and coated gloves to reduce skin permeation of nicotine and protect against green tobacco sickness.

A straightforward HPLC approach to testing butylated hydroxytoluene, an antioxidant, in pure and topical anti-burn gels; Evaluation of greenness, blueness, and whiteness grades