A Randomized, Evaluator-blinded, Parallel Group Light Dose Ranging Study of Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Levulan Topical Solution Vehicle + Blue Light on Moderate to Severe Facial Acne Vulgaris
Sponsor study identifier
interventional
266
1 country
14
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)The purpose of this study is to determine and compare the safety and efficacy of multiple broad area photodynamic therapy treatments with aminolevulinic acid (ALA-PDT) and vehicle (VEH-PDT) in subjects with moderate to severe facial acne vulgaris.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
June 24, 2008
Actual (reported)June 27, 2008
Actual (reported)July 2008
Actual (reported)July 2008
Actual (reported)August 21, 2009
Actual (reported)Change in Inflammatory Lesion Counts Relative to Baseline
Baseline and 3 weeks after final treatment
Investigator Global Assessment of Acne Severity Successes
Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.
Baseline and 3 weeks after final treatment
Percent Change in Inflammatory Lesion Counts Relative to Baseline
Baseline and 3 weeks after final treatment
Percent Change in Inflammatory Lesion Counts Relative to Baseline
Baseline and 6 weeks after final treatment
Subject Satisfaction Score
6 weeks after final treatment
Change in Inflammatory Lesion Counts Relative to Baseline
Baseline and 6 weeks after final treatment
Investigator Global Assessment of Acne Severity Successes
Baesline and 6 weeks after final treatment
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Levulan Kerastick containing 20% aminolevulinic acid HCL (ALA). Up to 4 treatments will be given at 3 week intervals.
Levulan Kerastick containing vehicle ingredients only (VEH). Up to 4 treatments will be given at 3 week intervals.
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Cherry Creek Research, Inc.
Denver, Colorado, 80209, United States
Kenneth R. Beer, M.D. P.A.
West Palm Beach, Florida, 33401, United States
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078, United States
Laser and Skin Surger Center of Indiana
Carmel, Indiana, 46032, United States
Derm Research PLLC
Louisville, Kentucky, 40217, United States
Stuart Marcus, M.D., PhD
Sponsor GmbH
266 participants (actual enrollment reported by the registry).
First Submitted
June 24, 2008
First Posted
June 27, 2008
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Downstate Med Ctr
Brooklyn, New York, 11203, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
Derm Research Inc
Austin, Texas, 78759, United States
Baylor Research Institute
Dallas, Texas, 75246, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124, United States
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Last Updated
October 24, 2011
Results First Posted
August 21, 2009
Record last verified: 2011-10
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Source: ClinicalTrials.gov.
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