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

Balmoral Medical company34 sites in 1 country1,236 target enrollmentOctober 10, 2018

ConditionsAcne Vulgaris

InterventionsGDC 268 Lotion Clindamycin Phosphate Lotion 1%GDC Vehicle Lotion

DrugsGDC 268 Lotion Clindamycin Phosphate Lotion 1%GDC Vehicle Lotion

Overview

Phase: Phase 3
Intervention: GDC 268 Lotion
Conditions: Acne Vulgaris
Sponsor: Balmoral Medical company
Enrollment: 1236
Locations: 34
Primary Endpoint: Mean Percent Change in the Number of Inflamed Lesions
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 10, 2018

End Date

April 16, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Balmoral Medical company

Responsible Party

Sponsor

Eligibility Criteria

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.