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Completed

NCT Number: NCT00219570

Dalacin-T Gel Post Approval Study

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

13 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clindamycin

Drug

nadifloxacin

Drug

Primary outcomes

  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 outcomes

  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

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Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Acronet
  • Bellsystem24 , Inc.
  • Mitsubishi Kagaku Bio-Clinical Laboratories, inc
  • Parexel
  • SACT INTERNATIONAL Co., LTD.
  • SATO Pharmaceutical Co., Ltd.

Registry information

Official study title

Phase IV Clinical Study Of Clindamycin Phosphate Topical Gel In The Treatment Of Acne Vulgaris

Important dates

Study start
2005
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
May 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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