Dalacin-T Gel Post Approval Study

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00219570

First Posted: September 22, 2005

Last Update Posted: May 11, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Parexel

SACT INTERNATIONAL Co., LTD.

Acronet

Bellsystem24 , Inc.

Mitsubishi Kagaku Bio-Clinical Laboratories, inc

Sato Pharmaceutical

Information provided by:

Pfizer

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 Intervention Model: Parallel Assignment Masking: Single 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

Information from the National Library of Medicine

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Ages Eligible for Study:	13 Years to 35 Years (Child, Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted:	September 13, 2005
First Posted:	September 22, 2005
Last Update Posted:	May 11, 2011
Last Verified:	May 2011

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

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