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.
Full Title of Study: “Phase IV Clinical Study Of Clindamycin Phosphate Topical Gel In The Treatment Of Acne Vulgaris”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single
- Drug: clindamycin
- Drug: nadifloxacin
Clinical Trial Outcome Measures
- To verify the non-inferiority to Acuatim cream of Dalacin T Gel in terms of the percent reduction in the inflammatory lesion count (the assessments of investigator) at Treatment Week 4 or EOT (discontinuation)
- To verify the non-inferiority to Acuatim cream of Dalacin T Gel in terms of the percent reduction in the inflammatory lesion count (the assessments of the Data Review Committee based on photographs) at Treatment Week 4 or EOT (discontinuation) According
Participating in This Clinical Trial
- 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.
- Patients with, for example, acne elastosis, steroidal acne, necrotizing acne, or occupational acne.
Gender Eligibility: All
Minimum Age: 13 Years
Maximum Age: 35 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Provider of Information About this Clinical Study
- Director, Clinical Trial Disclosure Group, Pfizer
- Overall Official(s)
- Pfizer CT.gov Call Center, Study Director, Pfizer
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