A 6-month, Multi-center, Double-blind, Controlled Study to Evaluate the Effect of a Biofilm Disrupting Acne Cream on Mild-to-Moderate Facial Acne in Female Volunteer Subjects.

Objectives: The primary aim of this study was to assess the change in acne lesions and severity within all treatment groups over the course of a six-month study. Methods: This was a six-month, multisite, randomized, double-blind, controlled study in female subjects with mild-to-moderate acne to assess the clinical and psychological outcomes of treatment with biofilm disrupting acne cream 2x, biofilm disrupting acne cream 1x, biofilm disrupting acne cream without salicylic acid, 2.5% benzoyl peroxide (BPO) gel, and placebo. Subjects applied the assigned product to their face twice daily and were evaluated for clinical acne and quality of life outcomes at baseline and after six, 12, 18, and 24 weeks of treatment. Results: After 24 weeks of use, subjects treated with biofilm disrupting acne cream 2x had a significantly greater improvement in the Investigator Global Assessment (IGA), compared to those treated with 2.5% BPO gel. Based on dermatologic assessments, biofilm disrupting acne cream 2x, biofilm disrupting acne cream 1x, biofilm disrupting acne cream without salicylic acid, and placebo control were associated with less erythema and dryness, compared to 2.5% BPO gel. Limitations: Assessments within this study had the potential for subjective differences due to variability between evaluators. Conclucion: Biofilm disrupting acne cream 2x and biofilm disrupting acne cream 1x provided equivalent efficacy to 2.5% BPO gel with less of the adverse effects commonly associated with BPO, such as erythema and dryness. Both the biofilm disrupting acne cream without salicylic acid and the placebo control were associated with mild improvements to acne symptoms over the course of the 24-week study. Trial Registry Information: ClinicalTrials.gov, NCT03106766.

Adhesion Evaluation of AG200-15: An Investigational Transdermal Contraceptive Delivery System.

INTRODUCTION: AG200-15, an investigational transdermal contraceptive delivery system or patch, is designed to be a low-dose, non-daily, combined hormonal contraceptive option for women. In this phase 1 study, the in vivo adhesion of the AG200-15 patch was compared to Xulane®, the only contraceptive patch available in the USA. METHODS: This phase 1, randomized, open-label, single-dose, two-treatment, two-period crossover adhesion study compared the 7-day adhesion of the AG200-15 and Xulane contraceptive patches. Eighty-three women, ages 18 to 35 years old, with body mass index (BMI) ≥ 19 kg/m2 and < 35 kg/m2, and weight ≥ 48 kg and < 90 kg were enrolled. Trained study site personnel used a five-point scale to assess patch adhesion daily. A score of 0 reflected at least 90% adhesion; while a score of 4 represented complete detachment of the patch. The primary objective was to compare the adhesion properties of the two patches; AG200-15 would be considered statistically non-inferior to Xulane if the upper 95% confidence limit (CL) of the mean difference in adhesion scores was below + 0.15. RESULTS: The overall mean (standard deviation) scores for AG200-15 (N = 78) and Xulane (N = 77) were 0.14 (0.28) and 0.39 (0.40), respectively (lower scores on the adhesion scale indicate better adhesion). The study demonstrated a difference in mean adhesion scores of - 0.24, meeting the prespecified non-inferiority criterion by demonstrating a one-sided upper CL of - 0.16. Thus, the in vivo adhesion of AG200-15 was shown to be non-inferior to that of Xulane. Most subjects experienced no skin irritation at the application site for either patch and no serious adverse event was reported in the study. CONCLUSION: The in vivo adhesion of AG200-15 is non-inferior to that of Xulane on the basis of the prespecified criterion of the upper bound of the one-sided 95% CL for the mean adhesion score difference being below + 0.15. Both patches were generally well tolerated. FUNDING: Agile Therapeutics, Inc.

Assessment of Taste and Grittiness of Riomet® ER Strawberry, Riomet® ER Grape, Riomet® Cherry, and Metformin Immediate-Release Tablets in Healthy Subjects.

OBJECTIVE: This study was conducted to evaluate the taste and grittiness of two formulations of Riomet® ER (metformin hydrochloride for extended release [ER] oral suspension 100 mg/mL) differing only in their flavoring agents (strawberry and grape) in comparison with two commercially available immediate-release (IR) formulations of metformin, Riomet® Cherry (metformin hydrochloride oral solution 500 mg/5 mL) and metformin IR tablets (metformin hydrochloride IR tablets 500 mg), in healthy human subjects aged 10-70 years. METHODS: Five comparison sets (i.e., Riomet® Cherry vs. Riomet® ER Strawberry; Riomet® Cherry vs. Riomet® ER Grape; metformin IR vs. Riomet® ER Strawberry; metformin IR vs. Riomet® ER Grape; and Riomet® Cherry vs. metformin IR) were evaluated. Riomet® ER was reconstituted as instructed on the label. Metformin IR tablets were crushed one at a time into a fine powder using a pharmaceutical pill crusher and mixed with 5 mL of water. A 2.5-mL dose of each product was administered to each subject. Subjects were instructed not to swallow any of the products. Each product in the comparison set was rated by the subjects for taste and grittiness according to a 7-point hedonic facial scale and a 5-point level of agreement scale. A comparison questionnaire was also completed by the subjects after evaluating each set. In all, 56 subjects were enrolled and 55 subjects completed the study. The taste preference was statistically evaluated. RESULTS AND CONCLUSIONS: All Riomet® formulations were significantly preferred overall to metformin IR crushed tablets. Both the strawberry and the grape flavors of Riomet® ER tended to be preferred to Riomet® Cherry.