Search

Objective: We sought to compare the efficacy and safety of encapsulated benzoyl peroxide (E-BPO) cream, 5%, versus vehicle in subjects <65 years of age versus subjects ≥65 with moderate to severe papulopustular rosacea., Methods: This analysis used pooled results from two 12-week, randomized, vehicle-controlled Phase III trials (NCT03564119, NCT03448939) of E-BPO cream, 5%. These trials included 733 subjects randomized 2:1 to E-BPO or vehicle. The primary endpoints were success in the Investigator's Global Assessment (IGA) score and reduction in mean inflammatory lesion count at Week 12., Results: Our analysis shows that E-BPO cream, 5%, was significantly superior to vehicle in achieving IGA success and reducing inflammatory lesions in both age groups. IGA success was achieved in 48.3% of subjects who received E-BPO versus 25.4% for vehicle in the intent-to-treat population. The E-BPO and vehicle IGA success percentages for subjects <65 were 45.7% and 23.8%, respectively, and those for subjects ≥65 were 60.0% and 28.1%, respectively. The absolute reduction from baseline in inflammatory lesions was -19.3 for subjects who received E-BPO versus -11.4 for those who received vehicle. The E-BPO and vehicle absolute reduction values for subjects <65 were -19.6 and -11.2, respectively, and 17.5 and -10.4 for subjects ≥65. There were no significant differences in the frequencies of adverse events or cutaneous tolerability., Limitations: E-BPO was not compared to nonencapsulated BPO., Conclusion: This combined analysis of results from the two Phase III, randomized, double-blind controlled studies of E-BPO cream, 5%, showed it was efficacious, tolerable, and safe, regardless of age., Competing Interests: DISCLOSURES: Dr. Baldwin is an investigator, advisor, and speaker for Galderma; an investigator, advisor, and speaker for Bausch Health, and an investigator and advisor for Sol-Gel Technologies Ltd. Dr. Bhatia is an advisor, consultant, and investigator for Galderma and Sol-Gel Technologies Ltd. Dr. Green is an investigator, speaker, and consultant for Galderma and Ortho Dermatologics. Dr. Sugarman is a consultant for Sol-Gel Technologies Ltd., Galderma, and Bausch Health., (Copyright © 2024. Matrix Medical Communications. All rights reserved.)

Objective: We sought to evaluate changes in microbiome biodiversity and physical properties of the skin after eight weeks of once-daily topical microencapsulated benzoyl peroxide (E-BPO) compared to vehicle cream in participants with rosacea., Methods: This was a randomized, double-blind, crossover, single-center, vehicle-controlled evaluation of E-BPO on the skin microbiome in rosacea. Participants had facial rosacea with global severity of 3 or 4 on the Investigator Global Assessment (IGA) scale. In the Treatment 1-2 group, participants received E-BPO for eight weeks then switched to vehicle cream for four weeks. In the Treatment 2-1 group, participants received vehicle cream for eight weeks, then E-BPO for four weeks., Results: Thirty-one participants were enrolled and randomly assigned to either group. Demographic characteristics were comparable between the treatment groups. After eight weeks of E-BPO treatment, there was a marked reduction in the relative abundance of Staphylococcus accompanied by an increase in Cutibacterium . At the species level, there was an increase in the relative abundance of C. acnes and a decrease in abundance of S. epidermidis . No noticeable difference was detected at the genus or species level at Week 8 in the 2-1 group. Sebum level, IGA, lesion counts, facial erythema, and inflammatory scores were improved with E-BPO versus vehicle cream. Adverse events were mild or moderate in severity., Limitations: The study included a small number of subjects and only surface-swabs were used for microbiome sampling., Conclusion: E-BPO shifted the skin microbiome in rosacea and demonstrated improvements in clinical symptoms and skin physical properties and a well-tolerated safety profile. US National Library of Medicine; Trial ID: NCT05675501]; URL: clinicaltrials.gov., Competing Interests: DISCLOSURES: Dr. Sivamani serves as a scientific adviser for LearnHealth, Arbonne, and Codex Labs and as a consultant to Burt’s Bees, Novozymes, Nutrafol, AbbVie, Sanofi, Fotona, Incyte, Leo, UCB, Novartis, Bristol Myers Squibb, Lilly, Sun, Pfizer, Almirall, and Regeneron Pharmaceuticals. Dr. York is an employee of Galderma Laboratories, L.P. Dr. Sugarman is a consultant and speaker for Pfizer, Regeneron, Sanofi, and Incyte; a consultant for Bausch Heath and Sol-Gel; and a medical safety monitor for Galderma clinical research trials. Dr. Gallo is a co-founder, scientific advisor, consultant and has equity in MatriSys Biosciences. Dr. Levy-Hacham and Ms. Mizrahi are employees of Sol-Gel Technologies., (Copyright © 2024. Matrix Medical Communications. All rights reserved.)

Background: Benzoyl peroxide and tretinoin are commonly prescribed acne treatments. Historically, they have been difficult to combine in a single formulation due to chemical instability, and both medications are potentially irritating. Microencapsulation helps overcome these challenges., Objective: Examine efficacy, safety, and tolerability of encapsulated BPO/encapsulated tretinoin (E-BPO/T) cream, 3%/0.1%., Methods: Subjects ≥9 years old with moderate to severe acne were enrolled in 2 multicenter, double-blind, vehicle-controlled, parallel trials and randomized (2:1) to 12 weeks of once-daily E-BPO/T (n = 571) or vehicle cream (n = 287)., Results: E-BPO/T was significantly superior to vehicle in both studies, with more subjects achieving IGA success with E-BPO/T (38.5%/25.4%) versus vehicle (11.5%/14.7%; P < .001/P = .017). The change from baseline in inflammatory lesion count for E-BPO/T was -21.6 versus -14.8 for vehicle (P < .001) in study 1 and -16.2 versus -14.1 (P = .018) in study 2. The changes from baseline in noninflammatory lesions for E-BPO/T were -29.7 versus -19.8 for vehicle (P < .001) and -24.2 and -17.4 (P < .001) in studies 1 and 2, respectively. E-BPO/T was well tolerated in both studies., Limitations: Long-term data are not available., Conclusion: E-BPO/T provided statistically significant and clinically relevant improvements in IGA and inflammatory and noninflammatory lesion counts and was well tolerated in subjects with moderate to severe acne., Competing Interests: Conflicts of interest Drs Del Rosso, Green, Lain, and Stein Gold each conducted the clinical trial research represented in this manuscript and received appropriate compensation for such. Dr Sugarman was the medical monitor. Dr Levy-Hacham and Ms. Mizrahi are employees of Sol-Gel Technologies, Ltd., (Copyright © 2023 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: A new formulation of benzoyl peroxide (E-BPO cream, 5%) entraps benzoyl peroxide (BPO) in silica microcapsules. This study assesses the efficacy, safety, and tolerability of E-BPO cream, 5%, in rosacea in two Phase III clinical trials., Methods: In two 12-week, randomized, double-blind, vehicle cream-controlled Phase III trials, 733 subjects at least 18 years old with moderate to severe rosacea were randomized (2:1) to once-daily E-BPO cream, 5%, or vehicle., Results: In Study 1, the proportion of subjects achieving IGA clear/almost clear at Week 12 was 43.5 percent for E-BPO cream, 5%, and 16.1 percent for vehicle. In Study 2, the respective values were 50.1 percent and 25.9 percent. In Study 1, the decrease in lesion count from baseline to Week 12 was -17.4 for E-BPO cream, 5%, versus -9.5 for vehicle. In Study 2, the respective values were -20.3 and -13.3 (all P <0.001). The difference was also significant at Week 2. There were no treatment-related serious adverse events; 1.4 percent of subjects (1.8% E-BPO cream, 5%, 0.4% vehicle) discontinued due to adverse events. Assessed local tolerability was found to be similar among subjects in both E-BPO and vehicle., E-BPO was not compared with unencapsulated BPO., Conclusion: E-BPO is an effective and well tolerated treatment for rosacea. Clinicaltrials.gov Identifiers: NCT03564119, NCT03448939., Competing Interests: DISCLOSURES: Dr. Baldwin is a consultant, investigator, and/or advisory board member for Galderma, Bausch Health, Almirall, Sun Pharma, La Roche Posay, and EPI. Dr. Bhatia is a consultant, investigator, and/or advisory board member for Abbvie, Almirall, Arcutis, Beiersdorf, Biofrontera, BMS, BI, Cara, Dermavant, EPI Health, Ferndale, Galderma, InCyte, ISDIN, J&J, LaRoche-Posay, Leo, Lilly, Ortho, Pfizer, Regeneron, Sanofi, SunPharma, and Verrica. Dr. Green is an investigator, speaker, and consultant for EPI Health, Galderma, Ortho Derm, and Sun Pharma. Drs. Levy-Hacham, Nov, and Ram report no conflicts of interest relevant to the content of this article. Dr. Stein Gold is an advisor, investigator, and speaker for Galderma, Ortho derm, Sun Pharma, and Almirall. Dr. Sugarman is a consultant for Sol Gel and Galderma. Dr. Werschler is a consultant, investigator, and advisory board member for Galderma., (Copyright © 2023. Matrix Medical Communications. All rights reserved.)

Objective: We sought to assess the long-term safety and tolerability of microencapsulated benzoyl peroxide cream, 5% (E-BPO cream, 5%), in subjects with rosacea. Efficacy and tolerability have been previously demonstrated in two 12-week, randomized, double-blind, vehicle-controlled Phase III trials., Methods: In this open-label extension study (NCT03564145; clinicaltrials.gov), all subjects from the initial placebo-controlled Phase III trials could receive E-BPO cream, 5%, for up to an additional 40 weeks, up to a total of 52 weeks of E-BPO cream, 5%, exposure. If a subject was assessed at study visits as "clear" or "almost clear" using the 5-point Investigator Global Assessment (IGA) scale (IGA 0 or 1), E-BPO cream, 5%, was not dispensed. If a subject was assessed as "mild to severe" (IGA 2+), E-BPO cream, 5%, was applied daily until they reached "clear" or "almost clear.", Results: The safety and tolerability profile for E-BPO cream, 5%, was similar to that reported in the Phase III studies. Five subjects (0.9%) discontinued study drug due to treatment-related adverse events, and 17 subjects (3.2%) experienced an adverse event considered related to study drug. IGA success after 40 weeks of active treatment was 66.5 percent for subjects continuing from the Phase III vehicle group (n=172) and 67.6 percent for subjects who continued Phase III E-BPO cream, 5% (n=363). The study ended early in accordance with the protocol., Limitations: Safety and tolerability of E-BPO were not compared with those of unencapsulated BPO., Conclusion: E-BPO cream, 5%, showed a favorable safety and tolerability profile during this 40-week, open-label extension study., Competing Interests: DISCLOSURES: Dr. Sugarman is a consultant and speaker for Arcutis, Pfizer, Regeneron, Sanofi, and Incyte; a consultant for Bausch Heath and Sol-Gel; and a medical safety monitor for Galderma clinical research trials and Dermavant clinical studies. Dr. Bhatia is an advisor, consultant, investigator, and speaker for Galderma. Dr. Baldwin is a speaker at Galderma, Bausch Health, Almirall, EPI, and Sun Pharma. Dr. Green is a speaker, consultant, investigator for Galderma and Ortho Dermatologics. Mr. Ram reports no conflict of interest. Dr. Nov is an employee of Sol-Gel Technologies. Dr. Stein Gold is an investigator, speaker, and advisor for Galderma, Ortho Derm, Sun Pharma, and Almirall. Dr. Werschler, Mr. Ram, and Dr. Levy-Hacham report no conflict of interest., (Copyright © 2023. Matrix Medical Communications. All rights reserved.)

Objective: Topical therapies remain the mainstay in treating patients with acne and rosacea. However, emerging real-world evidence demonstrates that desired treatment outcomes might not be achieved if patient satisfaction and adherence are low. Poor tolerability of active drug(s) and vehicle components and/or the drug delivery system could negatively influence adherence. Additionally, adherence might be lower with complex treatment regimens involving the application of multiple topical formulations. Optimizing vehicle tolerability and simplifying regimens that use fixed-dose combinations may improve treatment outcomes, better patient satisfaction, and reduce overall treatment costs. This qualitative review discusses several innovative drug delivery technologies and formulations aimed at improving patient satisfaction and adherence., Methods: The authors conducted a search of current and emerging topical drug delivery technologies used in clinical studies, reviewed primary literature on the chemical characteristics of topical dosage forms, and compared the impacts on treatment outcomes for acne and rosacea., Results: This article provides insight into innovative vehicles and drug delivery systems that have emerged allowing for fixed-dose combinations of incompatible active drugs and improving the tolerability of historically irritative active ingredients., Limitations: Further research is needed to fully highlight the impact of patient satisfaction and modern topical formulations on adherence and treatment outcomes., Conclusion: Drug microencapsulation is a delivery technology that has enabled development of a topical fixed-dose combination of benzoyl peroxide and tretinoin preventing the oxidation of tretinoin by benzoyl peroxide and improving the tolerability of the active ingredients., Competing Interests: DISCLOSURES: Dr. Stein Gold is an investigator, advisor, and/or speaker for Galderma, Sol Gel, Ortho Dermatologics, Sun Pharma, and Almirall. Dr. Draelos is a researcher and consultant for Galderma. Dr. Desai has served as a consultant for Galderma, and several other industry organizations in a role of a clinical investigator and/or consultant. The remaining authors have no relevant conflicts of interest to disclose related to the content of this article., (Copyright © 2023. Matrix Medical Communications. All rights reserved.)

Background: Benzoyl peroxide (BPO) has been used extensively in industry and health care for more than a century and has been approved for the treatment of acne for over 60 years. Recently, BPO received a second approved indication by the US Food and Drug Administration (FDA) for the treatment of rosacea. Topical BPO use has historically been limited by tolerability, photosensitivity, oxidation, and, uncommonly, contact allergy. Research has led to enhanced efficacy and tolerability, as well as the combination of BPO with other topical medications. These advances have allowed extended use of BPO in additional dermatologic conditions that may not have been feasible in the past. Additionally, the role of BPO in preventing antibiotic resistance cannot be underestimated. Here, we discuss the historical limitations of BPO and recent advances developed to overcome these limitations. We also describe newly approved BPO medications and their role in aiding antibiotic stewardship. J Drugs Dermatol. 2023;22(1):54-59. doi:10.36849/JDD.7150.

This phase 2, 12-week, multicenter, randomized, double-blind, active- and vehicle-controlled (VC), parallel-group trial assessed the efficacy and safety of silica encapsulated benzoyl peroxide BP (E-BP), two concentrations of silica encapsulated tretinoin (E-ATRA) and their combinations (TWIN high and low) vs VC in 726 males and females ≥9 years of age with moderate-to-severe inflammatory facial acne. The co-primary efficacy endpoints were Investigators Global Assessment (IGA) success rate ("clear" or "almost clear") and changes from baseline in inflammatory and non-inflammatory lesion counts. TWIN high and low were each significantly superior vs VC for IGA success at 12 weeks (39.7% and 27.4%, respectively, vs 12.3%, P < 0.001 and P < 0.01). TWIN high and low resulted in mean reductions in inflammatory lesions of -16.9 (64%) and -17.0 (60.8%) vs -11.5 (42%) for VC. Reductions in non-inflammatory lesions were -23.7 for TWIN low (54.9%) and -23.6 for TWIN high (53.3%) vs -13.7 (32.4%) for VC (all P < 0.001 vs VC). Results for TWIN were also numerically superior to E-BP and E-ATRA. All treatments were safe with comparable skin tolerability. The significant superiority of both combinations over VC and numerical superiority over E-BP and E-ATRA were achieved without an increase in adverse events or reduced skin tolerability.