Dalacin-T Gel Post Approval Study

This study has been completed.

Sponsor:

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

History of Changes

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 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 (Child, Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 Sebaceous Gland Diseases Clindamycin Clindamycin palmitate Clindamycin phosphate Nadifloxacin	Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Topoisomerase II Inhibitors Topoisomerase Inhibitors Antineoplastic Agents

ClinicalTrials.gov processed this record on September 29, 2016

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