Dalacin-T Gel Post Approval Study

Acne Vulgaris Clinical Trial

Official title:

Phase IV Clinical Study Of Clindamycin Phosphate Topical Gel In The Treatment Of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219570
• Other study ID #: A6881003
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: May 9, 2011
• Start date: January 2005
• Est. completion date: June 2005

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• clindamycin

• nadifloxacin

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Pfizer	Acronet, Bellsystem24 , Inc., Mitsubishi Kagaku Bio-Clinical Laboratories, inc, Parexel, SACT INTERNATIONAL Co., LTD., Sato Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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