A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris (DFD-03)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03290027|
Recruitment Status : Completed
First Posted : September 21, 2017
Last Update Posted : August 16, 2018
Enrollment of subjects with mild to moderate facial acne. Subjects with acne lesions of any severity on the chest and/or back (including shoulders) may be enrolled provided they have mild to moderate acne on the face. During the 12-week treatment period subjects will use the study product twice daily. Subjects will be instructed to treat the entire face (and chest and/or back including shoulders, if applicable).
Efficacy will be assessed by using an Investigator's Global Assessment scale (IGA 5 point scale) and by counting the number of inflammatory and non-inflammatory lesions on the face at Baseline and Weeks 4, 8, and 12.
Safety assessments will include the investigator's assessment of local cutaneous tolerance of the treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching; assessed separately on the chest and/or back including shoulders (if applicable), vital signs (blood pressure and pulse rate), and adverse events (AEs). Urine pregnancy tests will be performed at Baseline and at every visit through Week 12 for all female subjects. A physical examination will be performed.
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: DFD-03||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||550 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks|
|Actual Study Start Date :||July 31, 2017|
|Actual Primary Completion Date :||April 19, 2018|
|Actual Study Completion Date :||April 19, 2018|
DFD-03 (0.1% tazarotene) Lotion
Other Name: Tazarotene 0.1% Lotion
Placebo Comparator: Vehicle
DFD-03 (0% tazarotene) Lotion
Other Name: Tazarotene 0.1% Lotion
- Absolute change in the inflammatory lesion counts on the face [ Time Frame: Baseline to Week 12 ]Change in inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using a two way analysis of covariance (ANCOVA) model
- Absolute change in the non-inflammatory lesion counts on the face [ Time Frame: Baseline to Week 12 ]Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the same ANCOVA model
- Proportion of subjects with treatment success based on IGA score [ Time Frame: Baseline to Week 12 ]IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline) - will be analyzed using the Cochran-Mantel-Haenszel (CMH) test for general association
- Percent change in inflammatory and non-inflammatory lesion counts on the face [ Time Frame: Baseline to Week 12 ]The percent change from Baseline to Week 12 in inflammatory and non-inflammatory lesion counts on the face will be analyzed using a two-way analysis of covariance (ANCOVA) model
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290027
|United States, Texas|
|Plano, Texas, United States, 75024|
|Study Director:||Srinivas R. Sidgiddi, M.D.||Dr. Reddy's Laboratories|