FindTrial
Sign In

Dalacin-T Gel Post Approval Study

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00219570
Enrollment
134
Registered
2005-09-22
Start date
2005-01-31
Completion date
2005-06-30
Last updated
2011-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

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.

Interventions

DRUGclindamycin
DRUGnadifloxacin

Sponsors

Parexel
CollaboratorINDUSTRY
SACT INTERNATIONAL Co., LTD.
CollaboratorUNKNOWN
Acronet
CollaboratorINDUSTRY
Bellsystem24 , Inc.
CollaboratorINDUSTRY
Mitsubishi Kagaku Bio-Clinical Laboratories, inc
CollaboratorINDUSTRY
SATO Pharmaceutical Co., Ltd.
CollaboratorINDUSTRY
Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
13 Years to 35 Years
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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026