Combination Treatment for Moderate to Severe Acne

November 28, 2011 updated by: Medicis Global Service Corporation

A Phase IV, Open-Label Study Evaluating the Use of Solodyn (Minocycline HCL Extended-Release Tablets), Ziana, and Triaz Foaming Cloths as Combination Acne Therapy Prior to Treatment With Isotretinoin

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • Santa Monica, California, United States
    • Delaware
      • Hockessin, Delaware, United States
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
    • Nevada
      • Henderson, Nevada, United States
    • North Carolina
      • High Point, North Carolina, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Utah
      • Salt Lake City, Utah, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 30 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy and allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Open Label Combination
Solodyn, Ziana, Triaz FC
Drug: Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide
Solodyn 1 tablet, Q day Ziana Gel, topical Q am Triaz FC, topical Q night

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients showing improvement from Baseline and Week 12
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicis Global Service Corporation

Investigators

  • Study Chair: Mary Sanstead, BSN, CCRP, Medicis Global Service Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

September 17, 2010

First Submitted That Met QC Criteria

September 20, 2010

First Posted (ESTIMATE)

September 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 30, 2011

Last Update Submitted That Met QC Criteria

November 28, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-0104-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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