Dalacin-T Gel Post Approval Study

This study has been completed.

First Received: September 13, 2005 Last Updated: July 24, 2006 History of Changes

Sponsors and Collaborators:	Pfizer Parexel SACT INTERNATIONAL Co., LTD. Acronet Bellsystem24 , Inc. Mitsubishi Kagaku Bio-Clinical Laboratories, inc Sato Pharmaceutical
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00219570

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 IV

MedlinePlus related topics: Acne

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Opc 7251

U.S. FDA Resources

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

Estimated Enrollment:	130
Study Start Date:	January 2005
Estimated 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

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

Study placed in the following topic categories:

Anti-Bacterial Agents
Exanthema
Clindamycin
Facial Dermatoses
Clindamycin-2-phosphate

Facies
Skin Diseases
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:

Anti-Infective Agents
Clindamycin
Facial Dermatoses
Skin Diseases
Clindamycin-2-phosphate
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Sebaceous Gland Diseases
Acne Vulgaris
Pharmacologic Actions
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Acneiform Eruptions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 07, 2009