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 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
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 Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Clindamycin Clindamycin-2-phosphate |
Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013