Dalacin-T Gel Post Approval Study

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single

Interventions

  • Drug: clindamycin
  • Drug: nadifloxacin

Clinical Trial Outcome Measures

Primary 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)

Secondary 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 the Data Review Committee based on photographs) at Treatment Week 4 or EOT (discontinuation) According

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 13 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Collaborator
    • Parexel
  • 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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