Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
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|ClinicalTrials.gov Identifier: NCT03717506|
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : November 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: GDC 268 Lotion Drug: Clindamycin Phosphate Lotion 1% Drug: GDC Vehicle Lotion||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 268 and Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris|
|Actual Study Start Date :||October 3, 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Test product
GDC 268 Lotion applied topically as directed.
Drug: GDC 268 Lotion
GDC 268 is a topical lotion
Active Comparator: Reference Product
Clindamycin Phosphate Lotion, 1% applied topically as directed.
Drug: Clindamycin Phosphate Lotion 1%
Clindamycin Phosphate Lotion is an FDA-approved drug
Placebo Comparator: Placebo
GDC Vehicle lotion applied topically as directed.
Drug: GDC Vehicle Lotion
GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs
- Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) [ Time Frame: 12 weeks ]
- Mean percent change in the non-inflammatory (open and closed comedones) lesion counts [ Time Frame: 12 weeks ]
- The proportion of Subjects with a clinical response (IGA) of "success" at week 12. Success should be defined as an IGA score that is at least 2 grades less than the baseline assessment. [ Time Frame: 12 weeks ]
- Incidence of Adverse Events [ Time Frame: Day 1 through Day 85 ]Adverse Events (AEs) will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported by number and percentage.
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): NCT03717506
|Contact: Oleg Khatsenko||858-571-1800||ClinicalResearch@therapeuticsinc.com|
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