Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis
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|ClinicalTrials.gov Identifier: NCT00555646|
Recruitment Status : Terminated (Change of dose regimen (new protocol))
First Posted : November 9, 2007
Last Update Posted : July 9, 2009
This is an open label, single center, controlled study with each subject's two treatment plaque areas assigned by the investigator 1:1 to (a) PH-10 with ambient light exposure and (b) PH-10 with 544 nm LED light illumination at 10 J/cm2. A third plaque area will receive no treatment and serve as a control.
Subjects with at least three distinct, stable study plaque areas will receive the experimental therapy to two treatment plaque areas twice a week (2-5 days apart) for the lesser of 12 weeks or until remission is observed in the treatment plaque areas. If remission is observed in a treatment plaque area then treatment of that area will be discontinued and the area assessed weekly. A third plaque area (control plaque area) will receive no drug or light treatment and serve as an internal control.
Primary efficacy will be assessed 12 weeks after initial PH-10 treatment. Subjects will be followed for a total of 16 weeks to allow assessment of Durability of Response of treated lesions and comprehensive follow-up of adverse events.
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: PH-10 (rose bengal disodium 0.001%) Drug: Control||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||June 2009|
|Estimated Study Completion Date :||July 2009|
Each subject's study plaque areas will be assigned by the investigator to two PH-10 treatment plaque areas and one control plaque area.
Drug: PH-10 (rose bengal disodium 0.001%)
PH-10 with 544 nm LED light illumination
PH-10 with ambient light exposure
No treatment control.
- Treatment Success, defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale. [ Time Frame: 12 weeks ]
- Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4. [ Time Frame: 12 weeks ]
- Time to Remission (TTR) based on the (a) number of treatments and (b) days elapsed until Treatment Success is noted in each treatment plaque area. [ Time Frame: 12 weeks ]
- Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response. [ Time Frame: 16 weeks ]
- Adverse Experience. [ Time Frame: 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555646
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Amir Larian, MD||Icahn School of Medicine at Mount Sinai|