Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris
Information source: KGL, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Tazarotene 0.1% gel + placebo capsule, Oral minocycline (100 mg capsule) + vehicle gel, Tazarotene 0.1% gel + oral minocycline (100 mg capsule) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: KGL, Inc. Official(s) and/or principal investigator(s): James Leyden, MD, Principal Investigator, Affiliation: KGL, Inc.
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Global improvement from baseline at week 24
Secondary outcome: Lesion counts at weeks 16, 20 and 24
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
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
KGL, Inc, Broomall, Pennsylvania 19008, United States
Additional Information
Starting date: March 2002
Last updated: December 14, 2005
|