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Combination Treatment for Moderate to Severe Acne

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT01206348
First received: September 17, 2010
Last updated: November 28, 2011
Last verified: November 2011
History of Changes
  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: 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:

MedlinePlus related topics: Acne
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   12 Years to 30 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT01206348     History of Changes
Other Study ID Numbers: MP-0104-28
Study First Received: September 17, 2010
Last Updated: November 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Medicis Global Service Corporation:
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Tretinoin
Clindamycin
Minocycline
Dermatologic Agents
 Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on June 18, 2013