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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: GDC 268 Lotion; Drug: Clindamycin Phosphate Lotion 1%; Drug: GDC Vehicle Lotion

• Study Type: Interventional
• Enrollment (Actual): 1236
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Site 07
    • Rogers, Arkansas, United States, 72758
      • Site 22
  • California
    • Fountain Valley, California, United States, 92708
      • Site 25
    • Northridge, California, United States, 91324
      • Site 33
    • San Diego, California, United States, 92103
      • Site 30
  • Florida
    • Aventura, Florida, United States, 33180
      • Site 44
    • Brandon, Florida, United States, 33511
      • Site 36
    • DeLand, Florida, United States, 32720
      • Site 45
    • Largo, Florida, United States, 33770
      • Site 41
    • Miami, Florida, United States, 33145
      • Site 38
    • Miami Lakes, Florida, United States, 33014
      • Site 35
    • North Miami Beach, Florida, United States, 33162
      • Site 37
    • Saint Petersburg, Florida, United States, 33709
      • Site 26
    • Tampa, Florida, United States, 33609
      • Site 42
    • West Palm Beach, Florida, United States, 33406
      • Site 01
  • Georgia
    • Newnan, Georgia, United States, 30263
      • Site 10
  • Idaho
    • Boise, Idaho, United States, 83704
      • Site 09
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Site 05
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Site 02
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Site 27
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Site 28
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Site 24
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Site 49
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Site 06
    • Raleigh, North Carolina, United States, 27612
      • Site 32
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Site 19
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Site 17
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Site 34
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Site 20
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Site 08
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Site 29
    • Murfreesboro, Tennessee, United States, 37130
      • Site 03
    • Nashville, Tennessee, United States, 37215
      • Site 04
  • Texas
    • Sugar Land, Texas, United States, 77479
      • Site 43

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 product
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change in the Number of Inflamed Lesions	Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).	12 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gage Development Company, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): February 17, 2020
• Study Completion (Actual): April 16, 2020

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: April 9, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: zits; pimples; blackheads
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate
• Other Study ID Numbers: GDC-268-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No