A Phase 3, Double-Blind 2 Arm 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: | 3/17/2019 |
Start Date: | June 29, 2017 |
End Date: | September 5, 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 multicenter, randomized, double-blind, vehicle-controlled study designed to assess
the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle
Lotion.
the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with 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.
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;
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;
We found this trial at
41
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials