Trials / Unknown
UnknownNCT02491060
A Study Comparing the 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
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- Sponsor
- Valeant Pharmaceuticals · Industry
- Sex
- All
- Age
- 9 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to compare the efficacy, safety and tolerability of IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.
Detailed description
This is a multicenter, randomized, double-blind, parallel group, vehicle-controlled, 12-week study to evaluate relative changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Scale (EGSS) in subjects with moderate to severe acne. IDP-121 is a lotion for the topical treatment of acne.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IDP-121 Lotion | Investigational Product: IDP-121 Lotion |
| DRUG | IDP-121 Vehicle Lotion | Comparator Product: IDP-121 Vehicle Lotion |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2015-07-07
- Last updated
- 2015-09-14
Source: ClinicalTrials.gov record NCT02491060. Inclusion in this directory is not an endorsement.