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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: clindamycin Drug: nadifloxacin | Phase 4 |
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 |

- 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)
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 13 Years to 35 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Study Director: | Pfizer CT.gov Call Center | Pfizer |
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 |
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 |