Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-126 Gel in Comparison With Control Gel
Completed · Phase 1
Conditions studied: Acne Vulgaris
In brief
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.
Key facts
- Study ID
- NCT03653403
- Run by
- Bausch Health Americas, Inc.
- People needed
- 61
- Starts
- 2018-08-08
- Expected to finish
- 2019-06-19
- Last updated by the study team
- 2019-10-21
Who can join
Age: 9 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female, at least 9 years of age (at least 12 years of age for Control Gel);
- Verbal and signed written informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit);
- Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the screening and baseline visit
You may not qualify if…
- Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
- Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis, dermatitis, eczema;
- Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive;
- Subjects with a facial beard or mustache that could interfere with the study assessments;
- Subjects with more than two (2) facial nodules;
- Evidence or history of cosmetic-related acne
Where it is running
- Valeant Site 01 — Austin, Texas, United States
Full record on ClinicalTrials.gov
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