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A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne
This study is currently recruiting participants.
Verified by Stiefel Laboratories, April 2009
First Received: April 23, 2009   No Changes Posted
Sponsored by: Stiefel Laboratories
Information provided by: Stiefel Laboratories
ClinicalTrials.gov Identifier: NCT00887484
  Purpose

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


Condition Intervention Phase
Acne Vulgaris
Drug: BENZOYL PEROXIDE/ CLINDAMYCIN
Drug: BENZOYL PEROXIDE/ ADAPALENE
Phase IV

MedlinePlus related topics: Acne
Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Benzoyl peroxide Adapalene
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: A Single-Blind, Randomized, Comparative Pilot Study Evaluating the Tolerability of Two Topical Combination Therapies in the Treatment of Acne Vulgaris

Further study details as provided by Stiefel Laboratories:

Primary Outcome Measures:
  • Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy parameters ISGA, lesion counts, and Subject Global Change Assessment at each visit will be assessed, quality of life (SKINDEX-29) and product acceptability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: February 2009
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening.
Drug: 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.
2: Active Comparator
Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening.
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887484

Locations
Argentina, Buenos Aires
Hospital Italiano de Buenos Aires Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH
Contact: Pablo Tesolin, MD     (5411) 4959 0200     pablo.tesolin@hospitalitaliano.org.ar    
Principal Investigator: Pablo D Tesolin, MD            
Buenos Aires Skin Recruiting
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1055AAO
Contact: Pablo J. Gonzalez, MD     (5411) 5219 0541/42/43     gonzalezp@gmail.com    
Principal Investigator: Pablo J. Gonzalez, MD            
LUMIPIEL - Centro Dermatológico Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH
Contact: Eduardo A Rodriguez, MD     (5411) 4821 1020     dreduardorodriguez@fhertel.com.ar    
Principal Investigator: Eduardo A. Rodriguez, MD            
Centro de Investigación y Prevencion de Enfermidades Cardiovasculares Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1119
Contact: Tania Zarowsky, MD     (5411) 4827 3866     taniazaro@hotmail.com    
Principal Investigator: Tania Zarowsky, MD            
Sponsors and Collaborators
Stiefel Laboratories
Investigators
Study Director: Marcela Cirigliano, MD Stiefel Laboratories, Inc
  More Information

No publications provided

Responsible Party: Stiefel Laboratories, Inc. ( Jason Mann/Director, Global Clinical Operations )
Study ID Numbers: C0000-401
Study First Received: April 23, 2009
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00887484     History of Changes
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Stiefel Laboratories:
Acne Vulgaris
Acne

Study placed in the following topic categories:
Anti-Bacterial Agents
Exanthema
Clindamycin
Facial Dermatoses
Clindamycin-2-phosphate
Facies
Skin Diseases
Benzoyl Peroxide
Adapalene
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:
Anti-Infective Agents
Clindamycin
Facial Dermatoses
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Clindamycin-2-phosphate
Benzoyl Peroxide
Enzyme Inhibitors
Sebaceous Gland Diseases
Acne Vulgaris
Pharmacologic Actions
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Acneiform Eruptions
Therapeutic Uses
Dermatologic Agents

ClinicalTrials.gov processed this record on May 06, 2009