Light Treatment Effectiveness (LITE) Study

NCT03726489 | Completed Results FDA Device

• 2 other identifiers: 831323PCS-1608-35830
• Study Type: interventional
• Target: 783
• Locations: 1 country
• Sites: 38

Brief Summary

To compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis

Conditions

Psoriasis; Psoriatic Plaque

Outcome Measures

Primary Outcomes (2)

• Physician Global Assessment (PGA) Score of Clear/Almost Clear

  Measure of clinical treatment response, with PGA score of 0/1 (clear/almost clear). PGA score range from 0 (clear) to 5 (worst disease state).

  12 weeks after randomization or earlier at discontinuation of phototherapy

• Impact of Dermatological Disease on Quality of Life (DLQI ≤5)

  Dermatology Life Quality Index (DLQI) score of ≤5 which corresponds to no to small impact of dermatologic disease on quality of life. DLQI is a 10 item survey that asks patients questions about their health related quality of life on a 0-3 scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired

  12 weeks after randomization or earlier at discontinuation of phototherapy

Secondary Outcomes (14)

• Total Number of Phototherapy Treatments Received

  12 weeks after randomization or earlier at discontinuation of phototherapy

• Cumulative Dose of Phototherapy Received

  12 weeks after randomization or earlier at discontinuation of phototherapy

• Concomitant Topical Psoriasis Treatment

  week 12 and week 24 after randomization

• Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments

  week 12 and week 24 after randomization

• Patient-reported Time Spent on Phototherapy Per Treatment

  12 weeks after randomization or earlier at discontinuation of phototherapy

Other Outcomes (4)

• Safety Analysis of Skin Related Events

  Week 12

• Physician Global Assessment (PGA) Score of Clear/Almost Clear ("As Treated" Analysis)

  12 weeks after randomization or earlier at discontinuation of phototherapy

• Impact of Dermatological Disease on Quality of Life ("As Treated" Analysis)

  12 weeks after randomization or earlier at discontinuation of phototherapy

Study Arms (2)

Office Based Phototherapy

OTHER

Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.

Device: narrow band phototherapy clinic units

Home Based Phototherapy

ACTIVE COMPARATOR

Patients randomized to this arm will receive narrow band phototherapy in a home setting via Daavlin 7 series 3 panel narrow band phototherapy home units.

Device: Daavlin 7 series 3 panel narrow band phototherapy home units

Interventions

Daavlin 7 series 3 panel narrow band phototherapy home units DEVICE

Daavlin 7 series 3 panel narrow band phototherapy home units (with 8-12 bulbs and a smaller, flat surface with door, measuring 21" wide, 74.5" tall, and 23.5"). This unit is a class II device with a FDA 510K indication for psoriasis, vitiligo and atopic dermatitis/eczema. The unit will have a dosimetry controller, a UV sensor built in that measures the intensity of the light. This sensor will adjust the treatment time to compensate for any variation in output due to aging of the lamps or other factors

Home Based Phototherapy

narrow band phototherapy clinic units DEVICE

Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure

Office Based Phototherapy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
• Age 12 or older
• Plaque or guttate psoriasis predominantly located on trunk and/or extremities, with a physician global assessment average of \>1.0, and considered a candidate for phototherapy
• Patient is deemed willing and able to comply with either in-office or in-home phototherapy:
• In office: Able to travel about 3 times per week for 12 weeks from home, work and/or school during business hours of local site
• In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
• New or established patient in the practice

You may not qualify if:

• Patients who are judged unable or unwilling to comply with either in office or in home phototherapy due to time, work, school, or other financial constraints
• Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following:
• How to operate the phototherapy device
• How to follow the dosing protocol
• Requirement to wear protective eyewear and genital protection equipment
• Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit
• Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0
• Patients deemed unsafe to be treated with phototherapy:
• History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation
• History of arsenic intake
• Unable to tolerate standing for required duration of treatment due to age or physical function
• History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy
• Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of Utah: collaborator
• National Psoriasis Foundation: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (38)

Total Skin & Beauty Dermatology Center

Birmingham, Alabama, 35205, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Howard University

Washington D.C., District of Columbia, 20059, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Dawes Fretzin Clinical Research

Indianapolis, Indiana, 46256, United States

Location

MD Claiborne and Associates, LLC

New Orleans, Louisiana, 70115, United States

Location

MaineHealth/Maine Medical Center

Portland, Maine, 04102, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

DermAssociates LLC

Silver Spring, Maryland, 20902, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dermatology Specialist of Brighton

Brighton, Michigan, 48114, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Heymann, Manders, Green, and Sommer, LLC

Marlton, New Jersey, 08053, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87102, United States

Location

HHC Kings County Hospital

Brooklyn, New York, 10013, United States

Location

SUNY Downstate Health Sciences University

Brooklyn, New York, 11203, United States

Location

Buffalo Medical Group

Buffalo, New York, 14221, United States

Location

Infinity Dermatology NYC

Queens, New York, 11375, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State University

Columbus, Ohio, 43215, United States

Location

Pennsyvlania Centre For Dermatology

Exton, Pennsylvania, 19341, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Menter Dermatology Research Institute

Dallas, Texas, 75246, United States

Location

West Houston Dermatology

Houston, Texas, 77082, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Vermont & State Agriculture College

Burlington, Vermont, 05405, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Frontier Derm Partners CRO, LLC

Mill Creek, Washington, 98012, United States

Location

University of Wisconsin

Madison, Wisconsin, 53715, United States

Location

Related Publications (1)

• Gelfand JM, Armstrong AW, Lim HW, Feldman SR, Johnson SM, Claiborne WCC, Kalb RE, Jakus J, Mangold AR, Flowers RH, Bhutani T, Durkin JR, Bagel J, Fretzin S, Sheehan MP, Krell J, Reeder M, Kaffenberger J, Kartono F, Takeshita J, Bridges AM, Fielding E, Nehal US, Schaecher KL, Howard LM, Eakin GS, Baez S, Bishop BE, Fitzsimmons RC Jr, Papadopoulos M, Song WB, Linn KA, Hubbard RA, Shin DB, Callis Duffin K. Home- vs Office-Based Narrowband UV-B Phototherapy for Patients With Psoriasis: The LITE Randomized Clinical Trial. JAMA Dermatol. 2024 Dec 1;160(12):1320-1328. doi: 10.1001/jamadermatol.2024.3897.

  PMID: 39319513 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Brooke Bishop
• Organization: University of Pennsylvania

brooke.bishop@pennmedicine.upenn.edu

215-615-0523

Study Officials

• Joel M. Gelfand, MD,MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, randomized, active comparator effectiveness study

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 31, 2018
• Study Start: March 1, 2019
• Primary Completion: October 31, 2023
• Study Completion: December 30, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Locations

US (38)