Dalacin-T Gel Post Approval Study

Pfizer

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: nadifloxacin; Drug: clindamycin

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00219570

A6881003

Details and patient eligibility

About

To investigate, in a comparison vs. Acuatim cream (nadifloxacin cream), the efficacy and safety of Dalacin T Gel (clindamycin phosphate gel) as a therapeutic medication for acne vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify the clinical positioning of Dalacin T Gel.

Enrollment: 134 patients

Sex: All

Ages: 13 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acne vulgaris patients found by a investigator to have at least 10 inflammatory lesions (papules, pustules) on a portion of either a cheeks or the forehead, with an inflammation severity of moderate or worse.

Exclusion criteria

• Patients with, for example, acne elastosis, steroidal acne, necrotizing acne, or occupational acne.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind