Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

Stiefel

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Tazarotene cream; Drug: Vehicle cream; Drug: Vehicle gel; Drug: Benzoyl peroxide gel; Drug: Clindamycin gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00713609

114570

Details and patient eligibility

About

Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris.

You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

Full description

The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks.

Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.

Enrollment: 591 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion Criteria: Subjects must be males or females 12 to 45 years of age.
• Subjects must have acne on their face.
• Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit.
• Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
• Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements).
• Subjects must be able to complete the study and to comply with study instructions.

Exclusion criteria

• Subjects who are pregnant, trying to become pregnant, or breast-feeding.
• Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination
• History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products
• Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months.
• Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study.
• Other exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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591 participants in 6 patient groups, including a placebo group

1

Experimental group

Description:

Benzoyl peroxide/clindamycin gel + tazarotene cream

Treatment:

Drug: Tazarotene cream

Drug: Clindamycin gel

Drug: Benzoyl peroxide gel

2

Active Comparator group

Description:

Benzoyl peroxide/clindamycin gel + vehicle cream

Treatment:

Drug: Clindamycin gel

Drug: Vehicle cream

Drug: Benzoyl peroxide gel

3

Active Comparator group

Description:

Benzoyl peroxide gel + tazarotene cream

Treatment:

Drug: Tazarotene cream

Drug: Benzoyl peroxide gel

4

Active Comparator group

Description:

Clindamycin gel + tazarotene cream

Treatment:

Drug: Tazarotene cream

Drug: Clindamycin gel

5

Active Comparator group

Description:

Vehicle gel+ tazarotene cream

Treatment:

Drug: Tazarotene cream

Drug: Vehicle gel

6

Placebo Comparator group

Description:

Vehicle gel + vehicle cream

Treatment:

Drug: Vehicle cream

Drug: Vehicle gel