Evaluation of Efficacy, Duration of Remission and Safety of a Light and Occlusive Patch Therapy for Plaque Psoriasis

NCT03180866 | Unknown DMC

• 1 other identifier: L-003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Target Plaque Assessment (TPA) at 6 weeks

  Local efficacy will be evaluated with a 0-4 point scale for three signs and symptoms of psoriasis: erythema, plaque elevation, and scaling. Change in TPA score will be used to measure the efficacy of the Luma Light System at 6 weeks after treatment initiation compared to control. TPA change scores will be computed by subtracting scores at baseline from scores at 6 weeks. It is hypothesized that the decline in TPA scores will be greater for the Luma Light System (Arm B) than for the control (Arm A).

  6 weeks

Secondary Outcomes (8)

• Frequency and severity of device and / or procedure related adverse events

  6 weeks

• TPA at 2, 4, 22 and 30 weeks

  2, 4, 22 and 30 weeks

• Duration of remission

  30 weeks

• Subject Satisfaction

  4 weeks

• Compliance

  6 weeks

Study Arms (2)

Non-treatment Control

NO INTERVENTION

Control arm will not have any intervention

Luma Light System

EXPERIMENTAL

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

Device: Luma Light System

Interventions

Luma Light System DEVICE

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

Luma Light System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of any race, greater than 18 years of age.
• Verbal and written informed consent obtained from the subject.
• Has a clinical diagnosis of plaque psoriasis at the Screening and Baseline visits.
• Has an IGA score of 2 to 4 that is consistent between the Screening and Baseline visits.
• 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.
• 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.
• Is in good general health as determined by the Investigator based on the subject's medical history.
• 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.
• 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.
• Subject is willing and able to return for all study visits.

You may not qualify if:

• 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 Active Treatment Phase.
• 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.
• 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.
• Subject has known allergy or adverse reaction to skin adhesives or hydrogels or coal tar.

Sponsors & Collaborators

• Illumicure Inc: lead

Study Sites (4)

Redwood Dermatology Research

Santa Rosa, California, 95403, United States

RECRUITING

Dermatology Associates of Knoxville, PC

Knoxville, Tennessee, 37917, United States

RECRUITING

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

RECRUITING

Jordan Valley Dermatology Center

West Jordan, Utah, 84008, United States

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Liza Marie

CONTACT

707-755-3946; liza@redwoodfamilyderm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subject will act as their own control as one target plaque will receive treatment and one will not. This information will not be made available to the Investigators or the bio-statistician.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: June 8, 2017
• Study Start: December 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)