Recruiting

Light & Occlusive Patch

Sponsor:

Illumicure Inc

Code:

NCT03180866

Conditions

Psoriasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Luma Light System

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. Two interpatient arms will be used to compare the efficacy of combination of NBUVB with an occlusive dressing (active) to no treatment (control). 32 patients will be enrolled in this 30 week study.

Conditions

Psoriasis

Study ID

NCT03180866

Start date

Dec, 2016

Status verified date

Jun, 2017

Completion date

Mar, 2018

Anticipated

Primary completion date

Mar, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female of any race, greater than 18 years of age.
2. Verbal and written informed consent obtained from the subject.
3. Has a clinical diagnosis of plaque psoriasis at the Screening and Baseline visits.
4. Has an IGA score of 2 to 4 that is consistent between the Screening and Baseline visits.
5. TPA score of 5-12 and a score of at least 1 for each of the 3 different psoriasis signs and symptoms (erythema, plaque elevation, and scaling) at the baseline visits.
6. Has at least 2 plaques of at least 6cm by 3cm with TPA scores not differing from each other by a score of more than 1 that are at least 2 inches apart at the baseline visit.
7. Is in good general health as determined by the Investigator based on the subject's medical history.
8. Females of childbearing potential must have negative urine or blood 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.
9. Subject agrees to use only the Sponsor provided cleanser and lotion during the study phase unless given permission by Investigator to use other topicals on non-target plaques.
10. Subject is willing and able to return for all study visits.

Exclusion Criteria:

1. 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.
2. Presence of any concurrent skin condition that could interfere with the evaluation of the study device, as determined by the Investigator.
3. Female who is pregnant, nursing an infant, or planning a pregnancy during the Active Treatment Phase.
4. Treatment with any investigational drug or device within 2 weeks 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.
5. History of melanoma.
6. 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.
7. Subject has known allergy or adverse reaction to skin adhesives or hydrogels or coal tar.

Study Design

Enrollment

32 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

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.

Primary outcome measure

  • Target Plaque Assessment (TPA) at 6 weeks [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Redwood Dermatology Research

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Principal Investigator:

Jeffrey Sugarman, MD, PhD

Dermatology Associates of Knoxville, PC

Recruiting

Knoxville, Tennessee, United States, 37917

Contacts

Principal Investigator:

Edward Primka, MD

Texas Dermatology and Laser Specialists

Recruiting

San Antonio, Texas, United States, 78218

Contacts

Principal Investigator:

John C Browning, MD

Jordan Valley Dermatology Center

Recruiting

West Jordan, Utah, United States, 84008

Contacts

Principal Investigator:

Douglas W Forsha, MD

More Information

Sponsor

Illumicure Inc

Last update posted

Jun 8, 2017

Last verified

Jun, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Illumicure Inc on 2017-06-08.