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A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne

NCT ID: NCT00887484

Last Updated: 2016-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.

Detailed Description

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The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.

Conditions

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Acne Vulgaris

Keywords

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Acne Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Clindoxyl Gel

Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening.

Group Type EXPERIMENTAL

BENZOYL PEROXIDE/ CLINDAMYCIN

Intervention Type DRUG

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.

Epiduo gel

Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening.

Group Type ACTIVE_COMPARATOR

BENZOYL PEROXIDE/ ADAPALENE

Intervention Type DRUG

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.

Interventions

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BENZOYL PEROXIDE/ CLINDAMYCIN

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.

Intervention Type DRUG

BENZOYL PEROXIDE/ ADAPALENE

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Stiefel, a GSK Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Centro de Investigación y Prevencion de Enfermidades Cardiovasculares

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

LUMIPIEL - Centro Dermatológico

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Buenos Aires Skin

Ciudad de Buenos Aires, Buenos Aires, Argentina

Site Status

Countries

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Argentina

Study Documents

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Document Type: Clinical Study Report

View Document

Document Type: Informed Consent Form

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Document Type: Individual Participant Data Set

View Document

Document Type: Dataset Specification

View Document

Document Type: Study Protocol

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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114544

Identifier Type: -

Identifier Source: org_study_id