At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 36 enrolled
Drug / intervention
B244 +1 moredrug
Likely dose
B244 spray: 10 pumps (1.4 mL) applied twice daily to entire face for 14 daysAI-extracted
Key inclusion· 4
- ✓Age 18–45 years
- ✓Good general health with normal ECG, vital signs, and clinical laboratory results
- ✓Facial acne vulgaris: ≥105 inflammatory lesions, ≥10 non-inflammatory lesions, IGA ≥2
- ✓Willing to refrain from other acne treatments on face (except non-systemic agents on back/shoulders/chest)
Key exclusion· 10
- ✕Pregnancy, lactation, or attempting to conceive; positive β-hCG at screening or pre-dose
- ✕Skin conditions interfering with safety/efficacy assessment (rosacea, seborrheic dermatitis, perioral dermatitis, corticosteroid-induced acne/folliculitis)
- ✕Active cystic acne, acne congoblata, acne fulminans, or secondary acne
- ✕Two or more active nodular lesions
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double Blind, Placebo-Controlled, Single Center, Randomized, Sequential, Ascending 14-Day Multiple Dose Study in Subjects With Acne Vulgaris to Evaluate the Safety, Tolerability and Preliminary Efficacy of B244 Delivered as a Topical Spray
In Brief
A Phase 2 clinical trial evaluating B244 and Placebo for Acne Vulgaris. Completed, enrolled 36 participants across 1 site.
Detailed Summary
This is a single center, randomized, double-blind, placebo-controlled study in subjects with acne vulgaris.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartAug 2015
First PostedJan 2016
Primary CompletionMar 2016
Study CompletionJul 2016
TodayJul 2026
First PostedJan 15, 2016
Enrollment StartAug 5, 2015
Primary CompletionMar 1, 2016
Study CompletionJul 15, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.5 years ago
Interventions
B244drug
10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days
Placebodrug
10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days