Dalacin-T Gel Post Approval Study

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.

Study Type:  Interventional
Study Design:  Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:  Phase IV Clinical Study Of Clindamycin Phaosphate Topical Gel In The Treatment Of Acne Vulgaris

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:  130
Start Date:  January 2005
Completion Date:  June 2005

Eligibility
Ages Eligible for Study:  13 Years to 35 Years
Genders Eligible for Study:  Both

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

Study ID Numbers:  A6881003
First Received:  September 13, 2005
Last Updated:  July 24, 2006
ClinicalTrials.gov Identifier:  NCT00219570
Health Authority:  Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:
Exanthema
Clindamycin
Clindamycin-2-phosphate
Facies

Skin Diseases
Connective Tissue Diseases
Acne Vulgaris

Additional relevant MeSH terms:
Skin and Connective Tissue Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Clindamycin-2-phosphate
Facial Dermatoses

Acneiform Eruptions
Therapeutic Uses
Sebaceous Gland Diseases
Clindamycin
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 14, 2007