This will be an open-label study designed to assess the safety and plasma PK of topically applied IDP-126 Gel compared to Control Gel.
To evaluate the safety and plasma pharmacokinetics (PK) of clindamycin and adapalene in IDP-126 Gel compared with that from Control Gel in subjects with moderate to severe acne vulgaris (acne) during once daily topical application of IDP-126 Gel for 28 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Component A
gel
Valeant Site 01
Austin, Texas, United States
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
During the study, subjects will be assessed for the occurrence of new and ongoing AEs. Descriptions of AEs will include the dates of onset and resolution, maximum severity, seriousness, action taken regarding study drug, corrective treatment, outcome, and investigator's assessment of causality. Worsening of disease will not be considered an AE unless it results in discontinuation of the subject from the study or requires medical intervention prohibited by the protocol.
Time frame: All AEs will be followed from onset of the adverse event through the end of Study Day 28 visit
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