Dalacin-T Gel Post Approval Study

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborators: Acronet; Bellsystem24 , Inc.; Mitsubishi Kagaku Bio-Clinical Laboratories, inc; Parexel; SACT INTERNATIONAL Co., LTD.; Sato Pharmaceutical; SATO Pharmaceutical Co., Ltd.
• Treatments: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Nadifloxacin

Criteria

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.