Dalacin-T Gel Post Approval Study
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: clindamycin (Drug); nadifloxacin (Drug)
Phase: Phase 4
Sponsored by: Pfizer
Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Official title: Phase IV Clinical Study Of Clindamycin Phaosphate Topical Gel In The Treatment Of Acne Vulgaris
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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 outcome: 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)
Minimum age: 13 Years.
Maximum age: 35 Years.
- 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
Locations and Contacts
Starting date: January 2005
Ending date: June 2005
Last updated: July 24, 2006