Multi-center, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study in the Treatment of Acne Vulgaris
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This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123Vehicle Lotion.
Condition or disease
Drug: IDP-123 LotionDrug: IDP-123 Vehicle Lotion
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123Vehicle Lotion. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne.
A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-123 Lotion and IDP-123 Vehicle Lotion in the Treatment of Acne Vulgaris
Actual Study Start Date :
July 1, 2017
Actual Primary Completion Date :
April 26, 2018
Estimated Study Completion Date :
July 24, 2018
Resource links provided by the National Library of Medicine
Superiority in absolute change in mean inflammatory lesion counts [ Time Frame: Baseline to 12 Weeks ]
Superiority in absolute change from Baseline to Week 12 in mean inflammatory lesion counts
Percent of subjects who achieve at least a two-grade reduction from baseline in the Evaluator's Global Severity Score. [ Time Frame: Baseline to Week 12 ]
Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score. Evaluations will be scored on a scale of 0-4, with 0 being clear and 4 being severe.
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Ages Eligible for Study:
9 Years to 99 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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 baseline visit;
Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
Subjects with two or fewer facial nodules;
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, 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;