Status:
COMPLETED
A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Acne Vulgaris
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
Detailed Description
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00887484
Start Date
February 1 2009
End Date
June 1 2009
Last Update
December 13 2016
Active Locations (4)
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1
Centro de Investigación y Prevencion de Enfermidades Cardiovasculares
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1119
2
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH
3
LUMIPIEL - Centro Dermatológico
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH
4
Buenos Aires Skin
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1055AAO