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Dalacin-T Gel Post Approval Study

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.
 
ClinicalTrials.gov Identifier: NCT00219570
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 11, 2011
Sponsor:
Collaborators:
Parexel
SACT INTERNATIONAL Co., LTD.
Acronet
Bellsystem24 , Inc.
Mitsubishi Kagaku Bio-Clinical Laboratories, inc
SATO Pharmaceutical Co., Ltd.
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: clindamycin Drug: nadifloxacin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
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
Study Start Date : January 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

Eligibility Criteria
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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
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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 Co., Ltd.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00219570    
Other Study ID Numbers: A6881003
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 11, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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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