Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

• ClinicalTrials.gov Identifier: NCT00776919
• Recruitment Status: Completed
• First Posted: October 22, 2008
• Results First Posted: January 30, 2012
• Last Update Posted: November 23, 2016
• Sponsor: Stiefel, a GSK Company
• Collaborators: Rho, Inc.; Quintiles, Inc.; GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline ( Stiefel, a GSK Company )

Study Description

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

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: clindamycin / benzoyl peroxide gel; Drug: clindamycin gel; Drug: BPO gel; Drug: vehicle gel	Phase 3

Detailed Description:

A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1315 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of A Clindamycin / Benzoyl Peroxide Gel Versus Clindamycin Gel Versus Benzoyl Peroxide Gel Versus Vehicle Gel In Subjects With Acne Vulgaris
• Study Start Date: October 2008
• Actual Primary Completion Date: September 2009
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; clindamycin / benzoyl peroxide gel	Drug: clindamycin / benzoyl peroxide gel; Once a day application to the face
Active Comparator: 2; Clindamycin gel	Drug: clindamycin gel; Once a day application to the face
Active Comparator: 3; BPO gel	Drug: BPO gel; Once a day application to the face
Placebo Comparator: 4; vehicle gel	Drug: vehicle gel; Once a day application to the face

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 [ Time Frame: Baseline (Day 1) and 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.
2. Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts [ Time Frame: Baseline (Day 1) and Week 12 ]
   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.
3. Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts [ Time Frame: Baseline (Day 1) and Week 12 ]
   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).
4. Mean Change From Baseline to Week 12 in Total Lesion Counts [ Time Frame: Baseline (Day 1) and Week 12 ]
   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.

Secondary Outcome Measures :

1. Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) [ Time Frame: Baseline (Day 1) and Week 12 ]
   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. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100.
2. Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]
   During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.
3. Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]
   During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 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.
4. Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure [ Time Frame: Baseline (Day 1) and Week 12 ]
   Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
5. Mean Change From Baseline to Week 12 in Temperature [ Time Frame: Baseline (Day 1) and Week 12 ]
   Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
6. Mean Change From Baseline to Week 12 in Pulse Rate [ Time Frame: Baseline (Day 1) and Week 12 ]
   Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
7. Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling [ Time Frame: Baseline; Weeks 2, 4, 8, and 12 ]
   Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.
8. Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging [ Time Frame: Baseline; Weeks 2, 4, 8, and 12 ]
   Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.
9. Mean Duration of Study Product Use [ Time Frame: Baseline (Day 1) through Week 12 ]
   Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.
10. Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation [ Time Frame: Baseline (Day 1) through Week 12 ]
    An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 45 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, California

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

San Diego, California, United States, 92123

The Laser Institute for Dermatology

Santa Monica, California, United States, 90404

United States, Colorado

Cherry Creek Research, Inc.

Denver, Colorado, United States, 80209

United States, Florida

Skin Care Research, Inc.

Boca Raton, Florida, United States, 33486

University of Miami Cosmetic Medicine and Research Institute

Miami Beach, Florida, United States, 33140

FXM Research

Miami, Florida, United States, 33175

United States, Georgia

Atlanta Dermatology & Vein Research Center, LLC

Alpharetta, Georgia, United States, 30022

United States, Illinois

SKINQRI

Lincolnshire, Illinois, United States, 60069

United States, Indiana

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States, 46260

United States, Kentucky

DermResearch, PLLC

Louisville, Kentucky, United States, 40217

United States, Michigan

Somerset Skin Centre

Troy, Michigan, United States, 48084

United States, New York

Dermatology Associates of Rochester, PC

Rochester, New York, United States, 14623

DermResearch Center of New York

Stony Brook, New York, United States, 11790

United States, Tennessee

The Skin Wellness Center, PC

Knoxville, Tennessee, United States, 37922

United States, Texas

Arlington Center for Dermatology

Arlington, Texas, United States, 76011

Progressive Clinical Research

San Antonio, Texas, United States, 78229

Belize

Dermatology and Skin Care Center FXM Research International

Belize City, Belize

Dr. Moguel's Clinic/FXM Research International

Belize City, Belize

Canada, British Columbia

Guildford Dermatology Specialist

Surrey, British Columbia, Canada, V3R6A7

Canada, Ontario

Dermatrial Research

Hamilton, Ontario, Canada, L8N 1V6

Lynderm Research, Inc.

Markham, Ontario, Canada, L3P 1A8

North Bay Dermatology Centre

North Bay, Ontario, Canada, P1B3Z7

Canada

CRDQ Centre de Recherche Dermatologique du Quebec

Quebec, Canada, G1V 4X7

Nexus Clinical Research

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

Sponsors and Collaborators

Stiefel, a GSK Company

Rho, Inc.

Quintiles, Inc.

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

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

Study Data/Documents: Informed Consent Form 

Identifier: 114677
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 114677
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 114677
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 114677
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 114677
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 114677
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 114677
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

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.

• Responsible Party: Stiefel, a GSK Company
• ClinicalTrials.gov Identifier: NCT00776919
• Other Study ID Numbers: 114677
• First Posted: October 22, 2008
• Results First Posted: January 30, 2012
• Last Update Posted: November 23, 2016
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline ( Stiefel, a GSK Company ):

Acne Vulgaris; Acne

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents