Combination Treatment for Moderate to Severe Acne

NCT ID: NCT01206348

Last Updated: 2011-11-30

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

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-07-31

Brief Summary

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To determine if a combination of three currently approved acne products are safe and effective for the treatment of moderate to severe acne

Detailed Description

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A Phase IV, Open-Label Study Evaluating the treatment for Combination Acne Therapy.

Conditions

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Acne

Keywords

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Acne

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label Combination

Solodyn, Ziana, Triaz FC

Group Type EXPERIMENTAL

Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide

Intervention Type DRUG

Solodyn 1 tablet, Q day Ziana Gel, topical Q am Triaz FC, topical Q night

Interventions

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Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide

Solodyn 1 tablet, Q day Ziana Gel, topical Q am Triaz FC, topical Q night

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* moderate to severe acne, IGA = 3 or 4 (Investigator Global Assessment)

Exclusion Criteria

* pregnancy and allergies
Minimum Eligible Age

12 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medicis Global Service Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Sanstead, BSN, CCRP

Role: STUDY_CHAIR

Medicis Global Service Corporation

Locations

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Birmingham, Alabama, United States

Site Status

Santa Monica, California, United States

Site Status

Hockessin, Delaware, United States

Site Status

Chestnut Hill, Massachusetts, United States

Site Status

Detroit, Michigan, United States

Site Status

Henderson, Nevada, United States

Site Status

High Point, North Carolina, United States

Site Status

Hershey, Pennsylvania, United States

Site Status

Nashville, Tennessee, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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MP-0104-28

Identifier Type: -

Identifier Source: org_study_id