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

September 13, 2005
May 9, 2011
January 2005
Not Provided
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)
Same as current
Complete list of historical versions of study NCT00219570 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Dalacin-T Gel Post Approval Study
Phase IV Clinical Study Of Clindamycin Phosphate Topical Gel In The Treatment Of Acne Vulgaris

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Acne Vulgaris
  • Drug: clindamycin
  • Drug: nadifloxacin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
134
June 2005
Not Provided

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.
Both
13 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00219570
A6881003
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
  • Parexel
  • SACT INTERNATIONAL Co., LTD.
  • Acronet
  • Bellsystem24 , Inc.
  • Mitsubishi Kagaku Bio-Clinical Laboratories, inc
  • Sato Pharmaceutical
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

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