PCTA206/11 A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi Center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris.
Sponsor study identifier
interventional
153
1 country
15
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2012
Actual (reported)Study Completion
May 2012
Actual (reported)This study is intended to evaluate the efficacy and safety of Visonac Photodynamic Therapy (PDT) in patients with severe acne, score 4 on global IGA scale. The null hypothesis is that Visonac PDT is equal to vehicle PDT against the alternative hypothesis that Visonac PDT is different compared to vehicle PDT at week 12.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
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.
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 3, 2011
Actual (reported)May 4, 2011
Actual (reported)April 2012
Actual (reported)May 2012
Actual (reported)January 16, 2014
Actual (reported)Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).
From baseline to 12 weeks after first treatment
Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)
From baseline to 12 weeks after the first treatment
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.
From baseline to 12 weeks after the first treatment
Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.
From baseline to 12 weeks after first treatment
Pain During Illumination.
Immediately after first treatment
Number of Patients With Adverse Events.
From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration
active treatment with light dose of 37 Joule/cm2
Placebo treatment, Light dose 37 Joule/cm2
cream application prior to illumination with red light
placebo/vehicle cream application prior to illumination with red light
Dermatology Specialists Inc
Oceanside, California, 92056, United States
Rady Children's Hospital
San Diego, California, 92123, United States
North Florida Dermatology Associates
Jacksonville, Florida, 32204, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Dermatology Institute, DuPage Medical Group
Naperville, Illinois, 60563, United States
Deaconess Clinic Inc
Evansville, Indiana, 47713, United States
ActivMed Practices & Research Inc
David Pariser, MD
Virginia Clinical Research, Inc.
153 participants (actual enrollment reported by the registry).
First Submitted
May 3, 2011
First Posted
May 4, 2011
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
A Study of a New Drug Treatment for Acne
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.
Haverhill, Massachusetts, 10830, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Somerset Skin Centre
Troy, Michigan, 48084, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Clinical Partners LLC
Johnston, Rhode Island, 02919, United States
DermResearch Inc
Austin, Texas, 78759, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Premier Clinical Research
Spokane, Washington, 99216, United States
Primary Completion
April 2012
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
January 16, 2014
Results First Posted
January 16, 2014
Record last verified: 2013-12
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Source: ClinicalTrials.gov.
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