Recruiting

Luma Light System

Sponsor:

Illumicure Inc

Code:

NCT02447068

Conditions

Psoriasis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Luma Light System

Luma Light

Occlusive Dressing

Study Details

Brief summary:

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.

Conditions

Psoriasis

Study ID

NCT02447068

Start date

May, 2015

Status verified date

May, 2015

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female of any race, 18 to 65 (inclusive) years of age.
  • Verbal and written informed consent obtained from the subject.
  • Has a clinical diagnosis of mild to moderate psoriasis at the Screening and Baseline visits.
  • Has an IGA score of 2 or 3.
  • Target plaque assessment (TPA) score between 6-9 and a score of at least 2 for each of the 3 different psoriasis signs and symptoms (erythema, plaque elevation, and scaling)
  • Has at least 4 plaques of at least 10 cm2 with TPA scores not differing from each other by a score of more than 1
  • Is in good general health as determined by the Investigator based on the subject's medical history, vital signs and physical examination.
  • Females of childbearing potential must have negative urine pregnancy test results.
  • Females of childbearing potential agree to use acceptable methods of contraception from the screening visit continuously until 30 days after end of treatment.
  • Subject agrees to use only the Sponsor provided cleanser and lotion during the study period.
  • Subject is willing and able to return for all study visits.

Exclusion Criteria:

  • Presence of psoriasis that was previously treated with prescription medications prior to the Screening visit and was non-responsive to treatment, as determined by the Investigator.
  • Presence of any concurrent skin condition that could interfere with the evaluation of the study device, as determined by the Investigator.
  • Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
  • Treatment with any investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial with an investigational drug or device.
  • History of melanoma.
  • 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.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Non-treatment Control

Control arm will not have any intervention

active comparator: Occlusive Dressing

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

active comparator: Luma Light

A NBUVB light will be used as an active comparator.

experimental: Luma Light System

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

Interventions

Luma Light System

The Luma Light System combines a NBUVB light with an occlusive dressing.

Luma Light

NBUVB light

Occlusive Dressing

Off-the-shelf occlusive dressing

Primary outcome measure

  • Target Plaque Assessment [ Time Frame: 6 weeks ]
  • Local Skin Reactions [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Liza Marie

707-755-3946liza@redwoodfamilyderm.com

Locations

Redwood Family Dermatology

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Liza Marie

707-755-3946liza@redwoodfamilyderm.com

Principal Investigator:

Jeffrey Sugarman, MD, PhD

More Information

Sponsor

Illumicure Inc

Last update posted

May 20, 2015

Last verified

May, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Illumicure Inc on 2015-05-20.