Status and phase
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About
This is a single center, randomized, double-blind, placebo-controlled study in subjects with acne vulgaris.
Full description
After a screening visit and a one-week washout (if applicable), three sequential ascending doses of the study drug will be applied twice-daily (BID) for 14 days in three groups of subjects. Each group of subjects will be randomized to receive the planned doses of B244 or placebo BID
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male and female subjects ≥18 and ≤45 years of age
In good general health as determined by a thorough medical history and physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities, including hematology, clinical chemistry and urinalysis.
Clinical diagnosis of facial acne vulgaris defined as:
Willing to refrain from using any treatments, other than the investigational product, including antibiotics, for acne present on the face. Topical acne treatments that do not have significant or measurable systemic absorption (e.g., benzoyl peroxide, salicylic acid) are allowed for treatment of acne of the back, shoulders and chest only.
Ability to comprehend and comply with procedures
Agree to commit to participate in the current protocol
Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
36 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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