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Dalacin-T Gel Post Approval S...

Dalacin-T Gel Post Approval Study

NCT ID: NCT00219570

Last Updated: 2011-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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clindamycin

Intervention Type DRUG

nadifloxacin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parexel

INDUSTRY

Sponsor Role collaborator

SACT INTERNATIONAL Co., LTD.

UNKNOWN

Sponsor Role collaborator

Acronet

INDUSTRY

Sponsor Role collaborator

Bellsystem24 , Inc.

INDUSTRY

Sponsor Role collaborator

Mitsubishi Kagaku Bio-Clinical Laboratories, inc

INDUSTRY

Sponsor Role collaborator

SATO Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Other Identifiers

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A6881003

Identifier Type: -

Identifier Source: org_study_id

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