A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne
A Single-blind, Randomized, Comparative Pilot Study Evaluating the Tolerability of Two Topical Combination Therapies in the Treatment of Acne Vulgaris
1 other identifier
interventional
50
1 country
4
Brief Summary
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2009
Shorter than P25 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 23, 2009
CompletedFirst Posted
Study publicly available on registry
April 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
October 23, 2012
CompletedDecember 13, 2016
October 1, 2016
4 months
April 23, 2009
September 22, 2010
October 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Erythema (Redness)
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Weeks 1 and 2
Skin Dryness
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Weeks 1 and 2
Skin Peeling
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense.
Weeks 1 and 2
Irritant/Allergic Contact Dermatitis
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Weeks 1 and 2
Secondary Outcomes (40)
Erythema (Redness)
Weeks 5 and 8
Skin Dryness
Weeks 5 and 8
Skin Peeling
Weeks 5 and 8
Irritant/Allergic Contact Dermatitis
Weeks 5 and 8
Investigators Static Global Assessment
Baseline, Weeks 5, 8
- +35 more secondary outcomes
Study Arms (2)
Clindoxyl Gel
EXPERIMENTALSubject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening.
Epiduo gel
ACTIVE COMPARATORSubject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening.
Interventions
Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.
Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.
Eligibility Criteria
You may qualify if:
- Male or female subjects at least 21 years of age, in good general health with documented diagnosis of acne vulgaris.
- Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception Abstinence is considered an acceptable method of contraception.
- Inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) facial lesions.
- The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed
You may not qualify if:
- Female subjects who are pregnant, trying to become pregnant or breastfeeding.
- Subjects who have any clinically relevant finding at their baseline physical other than acne vulgaris.
- History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
- Use of topical antibiotics or anti-acne medications on the face and systemic antibiotics within the past 2 and 4 weeks, respectively.
- Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
- Use of systemic retinoids within the past 6 months.
- Facial procedures performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks or during the conduct of the study.
- Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, benzoyl peroxide or excipients of the study product.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stiefel, a GSK Companylead
- GlaxoSmithKlinecollaborator
Study Sites (4)
Centro de Investigación y Prevencion de Enfermidades Cardiovasculares
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1119, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1181 ACH, Argentina
LUMIPIEL - Centro Dermatológico
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1181 ACH, Argentina
Buenos Aires Skin
Ciudad de Buenos Aires, Buenos Aires, C1055AAO, Argentina
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2009
First Posted
April 24, 2009
Study Start
February 1, 2009
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
December 13, 2016
Results First Posted
October 23, 2012
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.