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...
Date First Received: September 13, 2005
Last Updated: July 24, 2006
Verified by: Pfizer, November 2005
Clinical Trial Phase: Phase 4 | Start Date: January 2005
Overall Status: Completed
Estimated Enrollment: 130
Brief Summary
Official Title: “Phase IV Clinical Study Of Clindamycin Phaosphate Topical Gel In The Treatment Of Acne Vulgaris”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: clindamycin
- Drug: nadifloxacin
Outcome Measures for this Clinical Trial
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
Criteria for Participation 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 for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 13 Years
Maximum Age for this Clinical Trial: 35 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00219570
Study ID Number: A6881003
ClinicalTrials.gov Identifier: NCT00219570
Health Authority: Japan: Ministry of Health, Labor and Welfare
Clinical Trials Authorship and Review
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