Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Status: | Completed |
---|---|
Conditions: | Acne, Acne, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 9 - Any |
Updated: | 1/12/2018 |
Start Date: | October 29, 2015 |
End Date: | March 20, 2017 |
A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, 2-Arm, Parallel Group
Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in
the Treatment of Acne Vulgaris
Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in
the Treatment of Acne Vulgaris
Key Inclusion Criteria:
- Male or female at least 9 years of age and older
- Written and verbal 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
Key Exclusion Criteria:
- 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, gram-negative folliculitis
- 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
We found this trial at
37
sites
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