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

NCT03717506 | Completed Phase 3 Results FDA Drug

• 1 other identifier: GDC-268-001
• Study Type: interventional
• Target: 1,236
• Locations: 1 country
• Sites: 34

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.

Conditions

Acne Vulgaris

Keywords

zits; pimples; blackheads

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12

  12 weeks

Other Outcomes (1)

• Incidence of Adverse Events

  Day 1 through Day 85

Study Arms (3)

Test product

EXPERIMENTAL

GDC 268 Lotion applied topically as directed.

Drug: GDC 268 Lotion

Reference Product

ACTIVE COMPARATOR

Clindamycin Phosphate Lotion, 1% applied topically as directed.

Drug: Clindamycin Phosphate Lotion 1%

Placebo

PLACEBO COMPARATOR

GDC Vehicle lotion applied topically as directed.

Drug: GDC Vehicle Lotion

Interventions

GDC 268 Lotion DRUG

GDC 268 is a topical lotion

Test product

Clindamycin Phosphate Lotion 1% DRUG

Clindamycin Phosphate Lotion is an FDA-approved drug product

Reference Product

GDC Vehicle Lotion DRUG

GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs

Placebo

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Balmoral Medical company: lead

Study Sites (34)

Site 07

Fort Smith, Arkansas, 72916, United States

Location

Site 22

Rogers, Arkansas, 72758, United States

Location

Site 25

Fountain Valley, California, 92708, United States

Location

Site 33

Northridge, California, 91324, United States

Location

Site 30

San Diego, California, 92103, United States

Location

Site 44

Aventura, Florida, 33180, United States

Location

Site 36

Brandon, Florida, 33511, United States

Location

Site 45

DeLand, Florida, 32720, United States

Location

Site 41

Largo, Florida, 33770, United States

Location

Site 38

Miami, Florida, 33145, United States

Location

Site 35

Miami Lakes, Florida, 33014, United States

Location

Site 37

North Miami Beach, Florida, 33162, United States

Location

Site 26

St. Petersburg, Florida, 33709, United States

Location

Site 42

Tampa, Florida, 33609, United States

Location

Site 01

West Palm Beach, Florida, 33406, United States

Location

Site 10

Newnan, Georgia, 30263, United States

Location

Site 09

Boise, Idaho, 83704, United States

Location

Site 05

Rolling Meadows, Illinois, 60008, United States

Location

Site 02

Plainfield, Indiana, 46168, United States

Location

Site 27

Overland Park, Kansas, 66215, United States

Location

Site 28

Clarkston, Michigan, 48346, United States

Location

Site 24

Fridley, Minnesota, 55432, United States

Location

Site 49

Omaha, Nebraska, 68134, United States

Location

Site 06

High Point, North Carolina, 27262, United States

Location

Site 32

Raleigh, North Carolina, 27612, United States

Location

Site 19

Dublin, Ohio, 43016, United States

Location

Site 17

Gresham, Oregon, 97030, United States

Location

Site 34

Philadelphia, Pennsylvania, 19103, United States

Location

Site 20

Warwick, Rhode Island, 02886, United States

Location

Site 08

Anderson, South Carolina, 29621, United States

Location

Site 29

Chattanooga, Tennessee, 37421, United States

Location

Site 03

Murfreesboro, Tennessee, 37130, United States

Location

Site 04

Nashville, Tennessee, 37215, United States

Location

Site 43

Sugar Land, Texas, 77479, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Gage Development Clinical Trials
• Organization: Gage Development Company

clinicalinfo@capstonedevservices.com

1-847-999-0600

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: October 10, 2018
• Primary Completion: February 17, 2020
• Study Completion: April 16, 2020
• Last Updated: May 4, 2021
• Results First Posted: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (34)