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

Phase 3

Completed

Conditions: Acne Vulgaris

Interventions: Drug: GDC 268 Lotion
Drug: GDC Vehicle Lotion
Drug: Clindamycin Phosphate Lotion 1%

Registration Number: NCT03717506

Lead Sponsor: Balmoral Medical company

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1236

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test product	GDC 268 Lotion	GDC 268 Lotion applied topically as directed.
Placebo	GDC Vehicle Lotion	GDC Vehicle lotion applied topically as directed.
Reference Product	Clindamycin Phosphate Lotion 1%	Clindamycin Phosphate Lotion, 1% applied topically as directed.

Primary Outcome Measures

Name	Time	Method
Mean Percent Change in the Number of Inflamed Lesions	12 weeks	Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).
Mean Percent Change in the Non-inflammatory Lesion Counts	12 weeks	Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts.

Secondary Outcome Measures

Name	Time	Method
The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12	12 weeks	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.

Trial Locations

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