Dalacin-T Gel Post Approval Study - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 24, 2006

Start Date ^ICMJE

January 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00219570 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Dalacin-T Gel Post Approval Study

Official Title ^ICMJE

Phase IV Clinical Study Of Clindamycin Phaosphate Topical Gel In The Treatment Of Acne Vulgaris

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Acne Vulgaris

Intervention ^ICMJE

Drug: clindamycin
Drug: nadifloxacin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

130

Completion Date

June 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

13 Years to 35 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00219570

Responsible Party

Study ID Numbers ^ICMJE

A6881003

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Parexel
SACT INTERNATIONAL Co., LTD.
Acronet
Bellsystem24 , Inc.
Mitsubishi Kagaku Bio-Clinical Laboratories, inc
Sato Pharmaceutical

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP