Dalacin-T Gel Post Approval Study - Full Text View

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 palmitate Clindamycin Palmitate Hydrochloride Clindamycin phosphate 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

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

Facial Dermatoses

Clindamycin-2-phosphate

Facies

Skin Diseases

Sebaceous Gland Diseases

Acne Vulgaris

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Bacterial Agents

Protein Synthesis Inhibitors

Molecular Mechanisms of Pharmacological Action

Acneiform Eruptions

Therapeutic Uses

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

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