Luma Light Therapy for Psoriasis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Illumicure Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a proof of concept, investigator blinded study to evaluate the efficacy and safety of a novel combination of a home narrow band ultraviolet B (NBUVB) lamp with an occlusive dressing in adult subjects with mild to moderate psoriasis vulgaris. Four interpatient arms will be used to compare the efficacy of combination of NBUVB with an occlusive dressing to the light alone and to dressing alone and no treatment. Ten patients will be enrolled in this 6 weeks study.

Eligibility Criteria

Adults aged 18-65 with mild to moderate psoriasis, who have specific scores on plaque assessments and are in good health. Women must agree to use contraception and not be pregnant or nursing. Participants can't join if they have skin conditions that could affect results, were non-responsive to previous psoriasis treatments, or recently took part in other drug/device trials.

Inclusion Criteria

Is in good general health as determined by the Investigator based on the subject's medical history, vital signs and physical examination

Verbal and written informed consent obtained from the subject

You have an IGA score of 2 or 3.

+8 more

Exclusion Criteria

Presence of any concurrent skin condition that could interfere with the evaluation of the study device, as determined by the Investigator

Subject has any medical, social or psychological conditions that, in the opinion of the Investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations

My psoriasis did not improve with prescription medications.

+3 more

Participant Groups

The study is testing the Luma Light System's effectiveness when combined with an occlusive dressing versus using the light or dressing alone, as well as no treatment at all. This six-week trial involves ten patients divided into four groups to compare these methods for treating psoriasis.

4Treatment groups

Experimental Treatment

Active Control

Group I: Luma Light SystemExperimental Treatment1 Intervention

The experimental arm will be a combination of an occlusive dressing and NBUVB light.

Group II: Non-treatment ControlActive Control1 Intervention

Control arm will not have any intervention

Group III: Occlusive DressingActive Control1 Intervention

An off-the-shelf dressing occlusive dressing will be used as an active comparator.

Group IV: Luma LightActive Control1 Intervention

A NBUVB light will be used as an active comparator.