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Combination Treatment for Moderate to Severe Acne

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206348
First Posted: September 21, 2010
Last Update Posted: November 30, 2011
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.
Information provided by (Responsible Party):
Medicis Global Service Corporation
  Purpose
To determine if a combination of three currently approved acne products are safe and effective for the treatment of moderate to severe acne

Condition Intervention Phase
Acne Drug: Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Medicis Global Service Corporation:

Primary Outcome Measures:
  • Proportion of patients showing improvement from Baseline and Week 12 [ Time Frame: Week 12 ]

Enrollment: 97
Study Start Date: September 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy and allergies
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01206348


Locations
United States, Alabama
Birmingham, Alabama, United States
United States, California
Santa Monica, California, United States
United States, Delaware
Hockessin, Delaware, United States
United States, Massachusetts
Chestnut Hill, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
United States, Nevada
Henderson, Nevada, United States
United States, North Carolina
High Point, North Carolina, United States
United States, Pennsylvania
Hershey, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Medicis Global Service Corporation
Investigators
Study Chair: Mary Sanstead, BSN, CCRP Medicis Global Service Corporation
  More Information

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT01206348     History of Changes
Other Study ID Numbers: MP-0104-28
First Submitted: September 17, 2010
First Posted: September 21, 2010
Last Update Posted: November 30, 2011
Last Verified: November 2011

Keywords provided by Medicis Global Service Corporation:
Acne

Additional relevant MeSH terms:
Minocycline
Clindamycin
Benzoyl Peroxide
Tretinoin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Antineoplastic Agents
Keratolytic Agents