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

Stiefel

Status and phase

Completed

Phase 4

Conditions

Acne Vulgaris

Treatments

Drug: BENZOYL PEROXIDE/ CLINDAMYCIN

Drug: BENZOYL PEROXIDE/ ADAPALENE

Study type

Interventional

Funder types

Industry

Identifiers

114544

Details and patient eligibility

About

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

Full description

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

Enrollment

50 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.