Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type … (NCT03507946) | Clinical Trial Compass
WithdrawnNot Applicable
Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris
Stopped: Lack of funding and sponsor decided to not pursue clinical trial
0Started 2023-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of treatment