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Light Treatment Effectiveness (LITE) Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17) 2. Age 12 or older. 3. 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. 4. Patient is deemed willing and able to comply with either in-office or in-home phototherapy: 1. 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. 2. In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions. 5. New or established patient in the practice.

Exclusion Criteria:

1. 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. 2. Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following: 1. How to operate the phototherapy device. 2. How to follow the dosing protocol. 3. Requirement to wear protective eyewear and genital protection equipment. 3. Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit. 4. Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0. 5. Patients deemed unsafe to be treated with phototherapy: 1. History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation. 2. History of arsenic intake. 3. Unable to tolerate standing for required duration of treatment due to age or physical function. 4. History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy. 6. Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03726489
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Pennsylvania
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Joel M. Gelfand, MD,MSCE
Principal Investigator Affiliation University of Pennsylvania
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis, Psoriatic Plaque
Additional Details

The primary objective of this study is 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. Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) will be used to assess effectiveness, safety (tolerability), and duration of treatment response. This is a three year pragmatic, randomized, active comparator effectiveness study.

Arms & Interventions

Arms

Other: Office Based Phototherapy

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

Active Comparator: Home Based Phototherapy

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.

Interventions

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

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

Device: - narrow band phototherapy clinic units

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Total Skin & Beauty Dermatology Center, Birmingham, Alabama

Status

Address

Total Skin & Beauty Dermatology Center

Birmingham, Alabama, 35205

Mayo Clinic Arizona, Scottsdale, Arizona

Status

Address

Mayo Clinic Arizona

Scottsdale, Arizona, 85259

Johnson Dermatology, Fort Smith, Arkansas

Status

Address

Johnson Dermatology

Fort Smith, Arkansas, 72916

University of Southern California, Los Angeles, California

Status

Address

University of Southern California

Los Angeles, California, 90033

University of California, San Francisco, San Francisco, California

Status

Address

University of California, San Francisco

San Francisco, California, 94143

George Washington University, Washington, District of Columbia

Status

Address

George Washington University

Washington, District of Columbia, 20037

Howard University, Washington, District of Columbia

Status

Address

Howard University

Washington, District of Columbia, 20059

Northwestern University, Chicago, Illinois

Status

Address

Northwestern University

Chicago, Illinois, 60611

Dawes Fretzin Clinical Research, Indianapolis, Indiana

Status

Address

Dawes Fretzin Clinical Research

Indianapolis, Indiana, 46256

MD Claiborne and Associates, LLC, New Orleans, Louisiana

Status

Address

MD Claiborne and Associates, LLC

New Orleans, Louisiana, 70115

MaineHealth/Maine Medical Center, Portland, Maine

Status

Address

MaineHealth/Maine Medical Center

Portland, Maine, 04102

Johns Hopkins University, Baltimore, Maryland

Status

Address

Johns Hopkins University

Baltimore, Maryland, 21287

DermAssociates LLC, Silver Spring, Maryland

Status

Address

DermAssociates LLC

Silver Spring, Maryland, 20902

Brigham and Women's Hospital, Boston, Massachusetts

Status

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Dermatology Specialist of Brighton, Brighton, Michigan

Status

Address

Dermatology Specialist of Brighton

Brighton, Michigan, 48114

Henry Ford Health System, Detroit, Michigan

Status

Address

Henry Ford Health System

Detroit, Michigan, 48202

Washington University in St. Louis, Saint Louis, Missouri

Status

Address

Washington University in St. Louis

Saint Louis, Missouri, 63130

East Windsor, New Jersey

Status

Address

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520

Heymann, Manders, Green, and Sommer, LLC, Marlton, New Jersey

Status

Address

Heymann, Manders, Green, and Sommer, LLC

Marlton, New Jersey, 08053

University of New Mexico, Albuquerque, New Mexico

Status

Address

University of New Mexico

Albuquerque, New Mexico, 87102

Montefiore Medical Center, Bronx, New York

Status

Address

Montefiore Medical Center

Bronx, New York, 10467

HHC Kings County Hospital, Brooklyn, New York

Status

Address

HHC Kings County Hospital

Brooklyn, New York, 10013

Brooklyn, New York

Status

Address

SUNY Downstate Health Sciences University

Brooklyn, New York, 11203

Buffalo Medical Group, Buffalo, New York

Status

Address

Buffalo Medical Group

Buffalo, New York, 14221

Infinity Dermatology NYC, Queens, New York

Status

Address

Infinity Dermatology NYC

Queens, New York, 11375

Wake Forest University Health Sciences, Winston-Salem, North Carolina

Status

Address

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Ohio State University, Columbus, Ohio

Status

Address

Ohio State University

Columbus, Ohio, 43215

Pennsyvlania Centre For Dermatology, Exton, Pennsylvania

Status

Address

Pennsyvlania Centre For Dermatology

Exton, Pennsylvania, 19341

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Temple University, Philadelphia, Pennsylvania

Status

Address

Temple University

Philadelphia, Pennsylvania, 19122

Dallas, Texas

Status

Address

Dermatology Treatment and Research Center

Dallas, Texas, 75230

Menter Dermatology Research Institute, Dallas, Texas

Status

Address

Menter Dermatology Research Institute

Dallas, Texas, 75246

West Houston Dermatology, Houston, Texas

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Address

West Houston Dermatology

Houston, Texas, 77082

University of Utah, Salt Lake City, Utah

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Address

University of Utah

Salt Lake City, Utah, 84112

Burlington, Vermont

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Address

University of Vermont & State Agriculture College

Burlington, Vermont, 05405

University of Virginia, Charlottesville, Virginia

Status

Address

University of Virginia

Charlottesville, Virginia, 22908

Frontier Derm Partners CRO, LLC, Mill Creek, Washington

Status

Address

Frontier Derm Partners CRO, LLC

Mill Creek, Washington, 98012

University of Wisconsin, Madison, Wisconsin

Status

Address

University of Wisconsin

Madison, Wisconsin, 53715

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