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 range18 Years – 65 Years

SexALL

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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 …

What they're measuring

Change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of treatment

Timeframe: 84 days from baseline

Trial details

NCT IDNCT03507946

SponsorIsmart

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01