Multi-center, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study in the Treatment of Acne Vulgaris
Status: | Completed |
---|---|
Conditions: | Acne, Acne, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 9 - 99 |
Updated: | 3/14/2019 |
Start Date: | July 1, 2017 |
End Date: | July 24, 2018 |
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
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 assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123Vehicle 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.
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.
Inclusion Criteria:
1. Male or female at least 9 years of age and older;
2. 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);
3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global
Severity assessment at the baseline visit;
4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count
no less than 20 but no more than 50;
5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no
less than 25 but no more than 100;
6. Subjects with two or fewer facial nodules;
Exclusion Criteria:
1. Use of an investigational drug or device within 30 days of enrollment or participation
in a research study concurrent with this study;
2. 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;
3. 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;
4. Subjects with a facial beard or mustache that could interfere with the study
assessments;
5. Subjects with more than two (2) facial nodules;
6. Evidence or history of cosmetic-related acne;
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