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Sponsored by: |
PhotoCure |
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Information provided by: | PhotoCure |
ClinicalTrials.gov Identifier: | NCT00933543 |
The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from 9 to 35 years old with Aktilite® CL512.
Condition | Intervention | Phase |
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Acne Vulgaris |
Drug: Visonac PDT (MAL PDT) Drug: Vehicle cream (placebo) Procedure: PDT |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double Blinded, Prospective, Randomized, Stratified, Placebo-Controlled, Multi-Center Study of Photodynamic Therapy With VisonacTM Cream in Patients With Moderate to Severe Acne Vulgaris. |
Estimated Enrollment: | 100 |
Study Start Date: | August 2009 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Visonac cream with PDT: Experimental
Active treatment, Light dose 37 J/cm2.
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Drug: Visonac PDT (MAL PDT)
Cream application followed by illumination with red light.
Procedure: PDT
Photodynamic Therapy - Light dose 37 J/cm2
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Vehicle cream with PDT: Placebo Comparator
Placebo treatment, Light dose 37 J/cm2.
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Drug: Vehicle cream (placebo)
Cream application followed by illumination with red light.
Procedure: PDT
Photodynamic Therapy - Light dose 37 J/cm2
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Double blinded, prospective, randomized, stratified, placebo-controlled, multi-center study in patients with moderate to severe acne vulgaris. Patients with facial severity grades 3 to 4 on the Investigator's Global Assessment (IGA) scale will be included. Each patient will be classified according to age in the two age groups 9 to 12 years and 13 to 35 years and randomized to either Visonac or vehicle cream within each age group. All patients will receive 4 treatments 2 weeks apart (at week 0, 2 ,4 and 6 week). Efficacy evaluation will be done after each treatment and at 12 weeks after the first treatment. Safety evaluations will be performed at each treatment visit and at 12 weeks after the first treatment. Photographs of patients will be taken before and after treatment at first and last treatment visit, and at 12 weeks after first treatment. Blood samples will be drawn at 3 visits; pre-treatment visit, one week after first treatment and at one week after last treatment visit.
Ages Eligible for Study: | 9 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients presenting with any of the following will not be included in the study:
Contact: Saeeda Rana, MSc | +4722061646 | sr@photocure.no |
Contact: Per Fuglerud, MSc | +4722061654 | pf@photocure.no |
United States, California | |
Children's Specialists of San Diego / Rady Children's Hospital San Diego | |
San Diego, California, United States, 92123 |
Principal Investigator: | Lawrence F. Eichenfield, M.D | Children's Specialists of San Diego / Rady Children's Hospital San Diego |
Responsible Party: | Photocure ( Saeeda Rana/ Clinical Trial Manager ) |
Study ID Numbers: | PC TA204/09 |
Study First Received: | July 2, 2009 |
Last Updated: | July 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00933543 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Acne Vulgaris Moderate to severe |
Exanthema Facial Dermatoses Facies |
Skin Diseases Sebaceous Gland Diseases Acne Vulgaris |
Facial Dermatoses Skin Diseases Acneiform Eruptions Sebaceous Gland Diseases Acne Vulgaris |