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

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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

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
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Shelton, Connecticut 06484
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Albuquerque, New Mexico 87103
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Needham, Massachusetts 02492
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