Resumen

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

Descripción detallada

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

Elegibilidad

Edad mínima: 21 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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.

Intervenciones

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.

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.

Ubicaciones

Centro de Investigación y Prevencion de Enfermidades Cardiovasculares

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

LUMIPIEL - Centro Dermatológico

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Buenos Aires Skin

Ciudad de Buenos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalStiefel, a GSK Company

ColaboradorGlaxoSmithKline

A Single-blind, Randomized, Comparative Pilot Study Evaluating the Tolerability of Two Topical Combination Therapies in the Treatment of Acne Vulgaris

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

BENZOYL PEROXIDE/ CLINDAMYCIN

BENZOYL PEROXIDE/ ADAPALENE

Ubicaciones

Centro de Investigación y Prevencion de Enfermidades Cardiovasculares

Hospital Italiano de Buenos Aires

LUMIPIEL - Centro Dermatológico

Buenos Aires Skin

Patrocinadores