Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

NCT00776919 | Completed Phase 3 Results

• 1 other identifier: 114677
• Study Type: interventional
• Target: 1,315
• Locations: 3 countries
• Sites: 24

Brief Summary

This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris; Acne

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12

  During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.

  Baseline (Day 1) and Week 12

• Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts

  During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules \[small inflamed elevation of the skin that is filled with pus\], papules \[solid elevation of skin with no visible fluid\], nodules \[larger than papules with significant depth\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.

  Baseline (Day 1) and Week 12

• Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts

  During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones \[blackheads\] and closed comedones \[whiteheads\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).

  Baseline (Day 1) and Week 12

• Mean Change From Baseline to Week 12 in Total Lesion Counts

  During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.

  Baseline (Day 1) and Week 12

Secondary Outcomes (10)

• Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)

  Baseline (Day 1) and Week 12

• Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12

  Week 12

• Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12

  Week 12

• Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure

  Baseline (Day 1) and Week 12

• Mean Change From Baseline to Week 12 in Temperature

  Baseline (Day 1) and Week 12

Study Arms (4)

1

EXPERIMENTAL

clindamycin / benzoyl peroxide gel

Drug: clindamycin / benzoyl peroxide gel

2

ACTIVE COMPARATOR

Clindamycin gel

Drug: clindamycin gel

3

ACTIVE COMPARATOR

BPO gel

Drug: BPO gel

4

PLACEBO COMPARATOR

vehicle gel

Drug: vehicle gel

Interventions

clindamycin / benzoyl peroxide gel DRUG

Once a day application to the face

1

clindamycin gel DRUG

Once a day application to the face

2

BPO gel DRUG

Once a day application to the face

3

vehicle gel DRUG

Once a day application to the face

4

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be 12 to 45 years of age, inclusive, and in good general health.
• Clinical diagnosis of acne vulgaris
• Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
• Have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
• Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian.

You may not qualify if:

• Are pregnant or breast-feeding.
• Have a history or presence of other conditions that may increase the risk of the subject participating in the study and/or affect the evaluated outcomes.
• Used topical antibiotics on the face or used systemic antibiotics within the past 2 weeks.
• Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
• Used systemic retinoids within the past 6 months or topical retinoids within the past 6 weeks.
• Received treatment with estrogens (including oral, implanted, injected and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to start of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
• Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates, etc.) within the past 2 weeks.
• Used abradents or facial procedures, within the past 2 weeks.
• Use medications that may exacerbate acne.
• Have a known hypersensitivity or have had previous allergic reaction to any of the active components, lincomycin, or excipients of the study product.
• Used any investigational therapy within the past 4 weeks, or currently participating in another clinical study.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• Rho, Inc.: collaborator
• Quintiles, Inc.: collaborator
• GlaxoSmithKline: collaborator

Study Sites (24)

Rady Children's Hospital San Diego, Div. of Pediatric & Adolescents Dermatology

San Diego, California, 92123, United States

Location

The Laser Institute for Dermatology

Santa Monica, California, 90404, United States

Location

Cherry Creek Research, Inc.

Denver, Colorado, 80209, United States

Location

Skin Care Research, Inc.

Boca Raton, Florida, 33486, United States

Location

FXM Research

Miami, Florida, 33175, United States

Location

University of Miami Cosmetic Medicine and Research Institute

Miami Beach, Florida, 33140, United States

Location

Atlanta Dermatology & Vein Research Center, LLC

Alpharetta, Georgia, 30022, United States

Location

SKINQRI

Lincolnshire, Illinois, 60069, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46260, United States

Location

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Dermatology Associates of Rochester, PC

Rochester, New York, 14623, United States

Location

DermResearch Center of New York

Stony Brook, New York, 11790, United States

Location

The Skin Wellness Center, PC

Knoxville, Tennessee, 37922, United States

Location

Arlington Center for Dermatology

Arlington, Texas, 76011, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78229, United States

Location

Dermatology and Skin Care Center FXM Research International

Belize City, Belize

Location

Dr. Moguel's Clinic/FXM Research International

Belize City, Belize

Location

Guildford Dermatology Specialist

Surrey, British Columbia, V3R6A7, Canada

Location

Dermatrial Research

Hamilton, Ontario, L8N 1V6, Canada

Location

Lynderm Research, Inc.

Markham, Ontario, L3P 1A8, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B3Z7, Canada

Location

CRDQ Centre de Recherche Dermatologique du Quebec

Québec, Quebec, G1V 4X7, Canada

Location

Nexus Clinical Research

St. John's, NL A1B 3E1, Canada

Location

Related Publications (1)

• Eichenfield LF, Alio Saenz AB. Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study. J Drugs Dermatol. 2011 Dec;10(12):1382-96.

  PMID: 22134562 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 23, 2016
• Results First Posted: January 30, 2012

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (16); BE (2); CA (6)