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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
Sponsor:
Information provided by (Responsible Party):
Dr Robin Stones, Ismart

Brief Summary:

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

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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)
Masking Description:

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.

Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Test

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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy male & females; 18 to 65 years of age with mild to moderate psoriasis ≤10 PASI according to the Psoriasis Area Severity Index.

Plaques comparable in terms of size, duration and severity and where possible on comparable body areas according to the localized psoriasis severity index (LPSI).

Fitzpatrick, I-V photo type skin types. Written informed consent is given. Volunteers agree NOT to use any over the counter or prescriptive psoriasis treatments during the study period unless specifically advised by the research staff.

Exclusion Criteria:

Volunteers who suffer from Erythrodermic, exfoliative or pustular psoriasis. Volunteers who suffer from a systemic photosensitive disorder such as Lupus erythematosus, photosensitive eczema or Albinism.

Volunteers who suffer from genetic deficiencies that increase susceptibility to dermatologic cancer such as Xeroderma pigmentosum.

Volunteers who suffer from diffuse actinic damage of the skin. Volunteers who suffer from localised fungal or bacterial skin infections in or around the treatment area.

Volunteers currently taking (or a history of taking) medication listed in Photosensitive drug list in instructions for use.

Subjects who have any known allergies to the ingredients in the emollient used in the study.

Volunteers with known malignancy and or undergoing chemotherapy, radiotherapy or high doses of corticosteroids.

Volunteer suffers from keloid scars, or birthmarks in the treatment area. Females who are pregnant, breastfeeding or who wish to become pregnant during the study period.

Enrolled in another clinical trial during the same study period. The volunteer has a planned hospital admission and/or surgical procedure for an illness or disease which existed before enrolment into the clinical trial and which may interfere with the course or outcome of the study.

The volunteer has a medical or psychological condition(s) associated with a risk of poor protocol compliance (e.g. alcoholism or drug abuse).

A volunteer is undergoing or is likely to undergo other treatments.


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Responsible Party: Dr Robin Stones, Principle Investigator, Ismart
ClinicalTrials.gov Identifier: NCT03507946     History of Changes
Other Study ID Numbers: version 2.1 March 24th 2018
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases