Dalacin-T Gel Post Approval Study
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Acne Vulgaris |
| Intervention | Drug: clindamycin Drug: nadifloxacin |
| Phase | Phase 4 |
| Sponsor | Pfizer |
| Responsible Party | Pfizer |
| ClinicalTrials.gov Identifier | NCT00219570 |
| First Received | September 13, 2005 |
| Last Updated | May 9, 2011 |
| Last verified | May 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 13, 2005 |
|---|---|
| Last Updated Date | May 9, 2011 |
| Start Date | January 2005 |
| Estimated Primary Completion Date | June 2005 |
| Current Primary 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) |
| Current Secondary 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 the Data Review Committee based on photographs) at Treatment Week 4 or EOT (discontinuation) According |
Descriptive Information[ + expand ][ + ]
| Brief Title | Dalacin-T Gel Post Approval Study |
|---|---|
| Official Title | Phase IV Clinical Study Of Clindamycin Phosphate Topical Gel In The Treatment Of Acne Vulgaris |
| Brief 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment |
| Condition | Acne Vulgaris |
| Intervention | Drug: clindamycin Drug: nadifloxacin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 134 |
| Estimated Completion Date | June 2005 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | 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 | Both |
| Ages | 13 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00219570 |
|---|---|
| Other Study ID Numbers | A6881003 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Pfizer |
| Study Sponsor | Pfizer |
| Collaborators | Parexel SACT INTERNATIONAL Co., LTD. Acronet Bellsystem24 , Inc. Mitsubishi Kagaku Bio-Clinical Laboratories, inc Sato Pharmaceutical |
| Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
| Verification Date | May 2011 |