Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris

This study has been completed.
Sponsor:
Collaborators:
Milton S. Hershey Medical Center
State University of New York - Downstate Medical Center
Jefferson Medical College of Thomas Jefferson University
New York University School of Medicine
Allergan
Information provided by:
KGL, Inc.
ClinicalTrials.gov Identifier:
NCT00145106
First received: September 1, 2005
Last updated: December 14, 2005
Last verified: September 2005
  Purpose

The purpose of the study is to compare the efficacy of three maintenance regimens (topical tazarotene, oral minocycline, or both) in sustaining improvement in acne.


Condition Intervention Phase
Acne Vulgaris
Drug: Tazarotene 0.1% gel + placebo capsule, Oral minocycline (100 mg capsule) + vehicle gel, Tazarotene 0.1% gel + oral minocycline (100 mg capsule)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Regimen of Tazorac .1% Gel & Minocycline Cap in Tx of Individuals w/Acne Vulgaris: Effects of Maintenance Therapy on Duration of Improvement of Tazorac .1% Gel Used in Conjunction w/Placebo Cap Compared w/Minocycline Cap Used in Conjunction w/Either Tazorac .1% Gel or Vehicle Gel

Resource links provided by NLM:


Further study details as provided by KGL, Inc.:

Primary Outcome Measures:
  • Global improvement from baseline at week 24

Secondary Outcome Measures:
  • Lesion counts at weeks 16, 20 and 24

Estimated Enrollment: 189
Study Start Date: March 2002
Estimated Study Completion Date: August 2002
Detailed Description:

For many years antibiotic therapy has been the backbone of therapy for inflammatory acne. However, topical retinoids also offer efficacy against inflammatory acne and the combination of a topical retinoid and an antibiotic can result in faster and more complete clearing of inflammatory lesions than either drug alone.

The reduced sensitivity of Propionibacterium acnes to antibiotics is a growing problem. Resistance is a major issue not only because it can result in treatment failure but also because of concerns that it may potentially be transferred to other bacteria that anti-acne antibiotics are used used against. One of the most important factors predisposing to the development of resistant strains of propionibacterium acnes is the prolonged use of antibiotics. Therefore, in order to help minimize the development for such resistance, it is evident that maintenance strategies for acne should aim to minimize the long-term use of antibiotics.

Topical retinoids are a rational choice for maintenance therapy due to their activity on microcomedones (the precursor for all acne lesions). Nevertheless, there is a paucity of data evaluating this use in a maintenance setting. The aim of this study was to determine whether patients with moderate to severe inflammatory acne who have achieved a good level of clearance (eg>/= 75%) can maintain the improvement in their acne using maintenance therapy. THe study compared the efficacy of three maintenance therapies (topical tazarotene, oral minocycline, and topical tazarotene plus oral minocycline) in sustaining the clinical improvement attained after initial topical tazarotene plus oral minocycline therapy.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Moderate facial acne vulgaris 25-60 facial inflammatory acne lesions 10-100 facial comedos No more than 2 facial nodular cystic lesions (no more than 5 mm in diameter) For females of child bearing potential, a regular menstrual cycle Negative urine pregnancy test

Exclusion Criteria:

Uncontrolled systemic disease Acne vulgaris known to be resistant to antibiotics For females: pregnancy, breastfeeding, or planning pregnancy Use of estrogens or birth control pills for 12 weeks or less Any skin disease that may interfere with diagnosis or evaluation of acne vulgaris Known hypersensivity to any components in Tazarac gel or to any tetracyclines Use of any systemic retinoids in past 2 years Use of any systemic antibiotics, or participation in another drug or investigational study, in past 30 days Use of topical anti-acne medication in past 14 days

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145106

Locations
United States, Pennsylvania
KGL, Inc
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
KGL, Inc.
Milton S. Hershey Medical Center
State University of New York - Downstate Medical Center
Jefferson Medical College of Thomas Jefferson University
New York University School of Medicine
Allergan
Investigators
Principal Investigator: James Leyden, MD KGL, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00145106     History of Changes
Other Study ID Numbers: T214
Study First Received: September 1, 2005
Last Updated: December 14, 2005
Health Authority: Canada: Ethics Review Committee

Keywords provided by KGL, Inc.:
acne, tazarotene, minocycline, maintenance, retinoid, efficacy, combination

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Minocycline
Tazarotene
Nicotinic Acids
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014