Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris
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|ClinicalTrials.gov Identifier: NCT03507946|
Recruitment Status : Not yet recruiting
First Posted : April 25, 2018
Last Update Posted : February 28, 2019
The purpose of this study is to investigate whether light therapy can help improve plaque psoriasis. This is a study based on a new medical device. The device produces its light from light emitting diodes. This type of technology has been used for several years in the treatment of other skin conditions. However, the investigators want to study the effect of a combination of very specific wavelengths of light on reducing the signs and symptoms of plaque psoriasis.
The Investigators are looking to recruit 25 volunteers from the general population between the ages of 18 and 65 years old with mild to moderate plaque psoriasis and who are otherwise healthy. The light treatments are 5 times a week for 12 weeks and the treatment is self-administered at home. Each treatment is 15 minutes. The total duration of the study is 16 weeks.
This is a controlled trial. This means that the volunteer will treat one plaque with the light therapy device and the other plaque will remain untreated for the period of the study.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Vulgaris||Device: Dermawrap - combined 460nm, 633nm and 830nm LED therapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Randomized, Blinded, Controlled Trial|
|Masking:||None (Open Label)|
Randomization will be conducted by the study coordinator and will take place in a separate room away from the PI.
The Study coordinator will number the 2 plaques 1 and 2. The Study coordinator will draw a sequential envelope containing the randomization code for the control and test. The code will inform the study coordinator which plaque is control and which test.
The Study coordinator will complete the randomization coding worksheet which identifies the test and control plaque and location.
The randomization coding worksheet will be kept separate from the subjects' case report form.
|Official Title:||Single Center, Randomized, Blinded, Controlled Trial Evaluating the Safety and Effectiveness of Combined 460nm, 633nm and 830nm LED Light for the Treatment of Mild to Moderate Plaque-Type Psoriasis Vulgaris|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||June 2020|
Subject self control; Plaque 1: Dermawrap - combined 460nm, 633nm, and 830nm LED therapyDaily treatments of 15 minutes of combined LED phototherapy, 5 days per week for 12 weeks.
Plaque 2: No Intervention
Device: Dermawrap - combined 460nm, 633nm and 830nm LED therapy
Daily treatments of 15 minutes of combined LED phototherapy, 5 days per week for 12 weeks.
- Change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of treatment [ Time Frame: 84 days from baseline ]A change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of treatment period (84 days)
- Change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of study period [ Time Frame: 112 days from baseline ]A change from baseline of the local psoriasis severity index (LPSI) compared to the control area 28 days after the end of the treatment.
- Safety evaluation; number of adverse incidents, evaluation of pigmentation of skin. [ Time Frame: Baseline onwards ]Number of adverse incidents including reporting on hyperpigmentation of skin.