Dalacin-T Gel Post Approval Study
This study has been completed.
Sponsor:
Pfizer
Collaborators:
Parexel
SACT INTERNATIONAL Co., LTD.
Acronet
Bellsystem24 , Inc.
Mitsubishi Kagaku Bio-Clinical Laboratories, inc
Sato Pharmaceutical
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00219570
First received: September 13, 2005
Last updated: May 9, 2011
Last verified: May 2011
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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 | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: clindamycin Drug: nadifloxacin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Phase IV Clinical Study Of Clindamycin Phosphate Topical Gel In The Treatment Of Acne Vulgaris |
Resource links provided by NLM:
MedlinePlus related topics:
Acne
Drug Information available for:
Clindamycin
Clindamycin hydrochloride
Clindamycin phosphate
Clindamycin palmitate hydrochloride
Clindamycin palmitate
U.S. FDA Resources
Further study details as provided by Pfizer:
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)
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
| Enrollment: | 134 |
| Study Start Date: | January 2005 |
| Study Completion Date: | June 2005 |
Eligibility| Ages Eligible for Study: | 13 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219570
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219570
Sponsors and Collaborators
Pfizer
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 |
More Information
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer |
| ClinicalTrials.gov Identifier: | NCT00219570 History of Changes |
| Other Study ID Numbers: | A6881003 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 9, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Facial Dermatoses Sebaceous Gland Diseases Skin Diseases |
ClinicalTrials.gov processed this record on March 03, 2015