A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne
Information source: Stiefel, a GSK Company
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: BENZOYL PEROXIDE/ CLINDAMYCIN (Drug); BENZOYL PEROXIDE/ ADAPALENE (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Stiefel, a GSK Company Official(s) and/or principal investigator(s):
Marcela Cirigliano, MD, Study Director, Affiliation: Stiefel Laboratories, Inc
Summary
The purpose of this study is to compare the tolerability of topical combination therapies in
the treatment of facial acne.
Clinical Details
Official title: A Single-Blind, Randomized, Comparative Pilot Study Evaluating the Tolerability of Two Topical Combination Therapies in the Treatment of Acne Vulgaris
Study design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)
Secondary outcome: Efficacy parameters ISGA, lesion counts, and Subject Global Change Assessment at each visit will be assessed, quality of life (SKINDEX-29) and product acceptability
Detailed description:
The purpose of this study is to compare the tolerability of topical combination therapies in
the treatment of facial acne.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aires, Buenos Aires 1181 ACH, Argentina; Recruiting
Pablo Tesolin, MD, Phone: (5411) 4959 0200, Email: pablo.tesolin@hospitalitaliano.org.ar
Pablo D Tesolin, MD, Principal Investigator
Buenos Aires Skin, Ciudad de Buenos Aires, Buenos Aires C1055AAO, Argentina; Recruiting
Pablo J. Gonzalez, MD, Phone: (5411) 5219 0541/42/43, Email: gonzalezp@gmail.com
Pablo J. Gonzalez, MD, Principal Investigator
LUMIPIEL - Centro Dermatológico, Ciudad Autonoma de Buenos Aires, Buenos Aires 1181 ACH, Argentina; Recruiting
Eduardo A Rodriguez, MD, Phone: (5411) 4821 1020, Email: dreduardorodriguez@fhertel.com.ar
Eduardo A. Rodriguez, MD, Principal Investigator
Centro de Investigación y Prevencion de Enfermidades Cardiovasculares, Ciudad Autonoma de Buenos Aires, Buenos Aires 1119, Argentina; Recruiting
Tania Zarowsky, MD, Phone: (5411) 4827 3866, Email: taniazaro@hotmail.com
Tania Zarowsky, MD, Principal Investigator
Additional Information
Starting date: February 2009
Ending date: August 2009
Last updated: June 8, 2009
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