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
  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:


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
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

No publications provided

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
Facial Dermatoses
Sebaceous Gland Diseases
Clindamycin
Clindamycin-2-phosphate
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014