Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717506
• Other study ID #: GDC-268-001
• Status: Completed
• Phase: Phase 3
• Start date: October 10, 2018
• Est. completion date: April 16, 2020

Study information

• Verified date: April 2021
• Source: Gage Development Company, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1236
• Est. completion date: April 16, 2020
• Est. primary completion date: February 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male or non-pregnant, non-lactating female, =12 and =40 years of age with a clinical diagnosis of acne vulgaris.

• Must have = 25 but = 100 non-inflammatory lesions (open and closed comedones) AND = 20 but = 70 inflammatory lesions (papules and pustules) AND = 2 nodulocystic lesions (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at Baseline.

• Must be willing and able to refrain from use of all other topical products in the treatment area, all acne medications other than test article, and all antibiotics (other than test article) during the 12-week treatment period.

• Women must be surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1).

• In good general health and free of any other clinically significant disease state or physical condition.

• Subject has provided written informed consent / assent.

Exclusion Criteria:

• Subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during the study.

• Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.

• Subject has excessive facial hair (e.g., beards, sideburns, moustaches), facial tattoos, or other facial attributes that would interfere with diagnosis or assessment of acne vulgaris in the opinion of the investigator.

• Subject is planning surgery during the study.

• Subject has a history of hypersensitivity or allergy to clindamycin or lincomycin and/or any of the ingredients in the test articles.

Other Eligibility Criteria not listed above will be reviewed for each prospective subject by the study staff.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• GDC 268 Lotion
GDC 268 is a topical lotion
• Clindamycin Phosphate Lotion 1%
Clindamycin Phosphate Lotion is an FDA-approved drug product
• GDC Vehicle Lotion
GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs

Locations

Country	Name	City	State
United States	Site 08	Anderson	South Carolina
United States	Site 44	Aventura	Florida
United States	Site 09	Boise	Idaho
United States	Site 36	Brandon	Florida
United States	Site 29	Chattanooga	Tennessee
United States	Site 28	Clarkston	Michigan
United States	Site 45	DeLand	Florida
United States	Site 19	Dublin	Ohio
United States	Site 07	Fort Smith	Arkansas
United States	Site 25	Fountain Valley	California
United States	Site 24	Fridley	Minnesota
United States	Site 17	Gresham	Oregon
United States	Site 06	High Point	North Carolina
United States	Site 41	Largo	Florida
United States	Site 38	Miami	Florida
United States	Site 35	Miami Lakes	Florida
United States	Site 03	Murfreesboro	Tennessee
United States	Site 04	Nashville	Tennessee
United States	Site 10	Newnan	Georgia
United States	Site 37	North Miami Beach	Florida
United States	Site 33	Northridge	California
United States	Site 49	Omaha	Nebraska
United States	Site 27	Overland Park	Kansas
United States	Site 34	Philadelphia	Pennsylvania
United States	Site 02	Plainfield	Indiana
United States	Site 32	Raleigh	North Carolina
United States	Site 22	Rogers	Arkansas
United States	Site 05	Rolling Meadows	Illinois
United States	Site 26	Saint Petersburg	Florida
United States	Site 30	San Diego	California
United States	Site 43	Sugar Land	Texas
United States	Site 42	Tampa	Florida
United States	Site 20	Warwick	Rhode Island
United States	Site 01	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gage Development Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Adverse Events	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.	Day 1 through Day 85
Primary	Mean Percent Change in the Number of Inflamed Lesions	Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).	12 weeks
Primary	Mean Percent Change in the Non-inflammatory Lesion Counts	Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts.	12 weeks
Secondary	The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12	Investigator's Global Assessment, IGA. Overall severity of acne was assessed using a five-point scale from 0=Clear to 4=Severe. Subjects must have had an IGA score of 2 (mild), 3 (moderate), or 4 (severe) at Baseline. Success is defined as an IGA score at week 12 that is at least 2 grades less than the baseline assessment.	12 weeks