This is a phase 2b, randomized, double-blind, vehicle-controlled clinical trial evaluating the efficacy, safety, and tolerability of B244 compared to vehicle in the treatment of moderate to severe acne vulgaris in adolescents and adults. Participants who meet the study entry criteria will be randomized in a 1:1 ratio to receive twice daily topical doses of B244 O.D. 5.0 or vehicle (control) for 12 weeks.
Males and females age 12 years and older
Participants (and/or parents or guardians) willing and able to provide informed consent/assent and to comply with the study protocol
IGA 3-4, and;
≥20 to ≤100 inflammatory lesions (papules, pustules, nodules), and;
Use of topical acne treatments, including benzoyl peroxide within 2 weeks prior to randomization to end of follow-up, retinoids (e.g., tretinoin, tazarotene, adapalene, trifarotene) within 4 weeks prior to randomization to end of follow up, antibiotics (e.g., clindamycin, erythromycin, dapsone), and combinations thereof, within 2 weeks prior to randomization to end of follow-up
Use of oral/systemic acne treatments, including antibiotics (e.g., minocycline, doxycycline, tetracycline, erythromycin, trimethoprim sulfamethoxazole, dapsone) within 4 weeks prior to randomization to end of follow-up, retinoid (e.g., isotretinoin or its derivatives) within 6 months prior to randomization to end of follow-up, vitamin A (retinol) supplements greater than 10,000 units/day within 4 weeks prior to randomization to end of follow-up, and zinc within 4 weeks prior to randomization to end of follow-up
Use of oral/systemic androgen receptor blockers (such as spironolactone, flutamide, cyproterone acetate, or bicalutamide) within 3 months prior to randomization to end of follow-up
Use of topical androgen receptor blockers (such as clascoterone) within 4 weeks prior to randomization to end of follow-up
Parallel
B244
Biological/VaccineB244 suspension
Vehicle
Biological/VaccineVehicle suspension
Proportion of participants with IGA success, defined as IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement
The Investigator Global Assessment (IGA) is a validated 5-point static scale (0 = Clear to 4 = Severe) used to rate the overall severity of facial acne vulgaris at each assessment timepoint.
Mean change in log inflammatory lesion count
Inflammatory lesions are defined as papules, pustules, and nodules (cysts are excluded from eligibility). The inflammatory lesion count provides a continuous, objective, quantitative measure of disease activity that is sensitive to treatment effects and endorsed by the FDA as a co-primary or key secondary endpoint in acne drug development. The mean change in log-transformed lesion count corresponds to a geometric mean ratio, which can be interpreted as a proportional reduction in inflammatory burden.
Mean change in absolute lesion count
Absolute lesion count changes complement the log-transformed analysis by providing directly interpretable counts of lesion reductions.
Mean change in log inflammatory lesion count
Inflammatory lesions are defined as papules, pustules, and nodules (cysts are excluded from eligibility). The inflammatory lesion count provides a continuous, objective, quantitative measure of disease activity that is sensitive to treatment effects and endorsed by the FDA as a co-primary or key secondary endpoint in acne drug development. The mean change in log-transformed lesion count corresponds to a geometric mean ratio, which can be interpreted as a proportional reduction in inflammatory burden.
Percent change in inflammatory lesion count
Inflammatory lesions are defined as papules, pustules, and nodules (cysts are excluded from eligibility). The inflammatory lesion count provides a continuous, objective, quantitative measure of disease activity that is sensitive to treatment effects and endorsed by the FDA as a co-primary or key secondary endpoint in acne drug development. The mean change in log-transformed lesion count corresponds to a geometric mean ratio, which can be interpreted as a proportional reduction in inflammatory burden.
Mean change in absolute and log total lesion count
Lesion count data are log-transformed prior to analysis to normalize the characteristically right- skewed distribution of count data. The mean change in log-transformed lesion count corresponds to a geometric mean ratio, which can be interpreted as a proportional reduction in inflammatory burden. Absolute lesion count changes complement the log-transformed analysis by providing directly interpretable counts of lesion reductions.
Percent change in total lesion count
The total lesion count is the sum of total inflammatory and total non-inflammatory lesion counts.
Mean change in absolute and log non-inflammatory lesion count
Absolute lesion count changes complement the log-transformed analysis by providing directly interpretable counts of lesion reductions. Non-inflammatory lesion counts capture comedone burden, which is an important component of acne pathophysiology that may respond differently to treatment than inflammatory lesions.
Percent change in non-inflammatory lesion count
Non-inflammatory lesion counts capture comedone burden, which is an important component of acne pathophysiology that may respond differently to treatment than inflammatory lesions. Non-inflammatory lesions: open comedones (blackheads) and closed comedones (whiteheads) (counted separately; summed as total non-inflammatory lesion count).
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AOBiome LLC
Lead sponsor
bioRASI, LLC
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
