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Excimer Laser Phototherapy Outcomes in the Treatment of Psoriasis (Photos)

Primary Purpose

Psoriasis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Excimer laser phototherapy

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of chronic plaque psoriasis for at least 6 months
Age ≥ 18 years
Body surface area affected ≤ 10 percent
Presence of at least one pair of bilateral target lesions with an area of at least 20 cm2 per target lesion. The bilateral target lesions must be present in the same category of anatomical region (e.g., bilateral lower extremities, bilateral upper extremities or bilateral trunk).

Exclusion Criteria:

active or past history of erythrodermic psoriasis, guttate psoriasis, or pustular psoriasis
history of photosensitivity disorder
history of malignant melanoma
active, invasive non-melanoma skin carcinoma
Fitzpatrick Skin Type I
Subject has received ultraviolet B phototherapy or any topical anti-psoriatic therapy within two weeks prior to starting the study.
Subject has received systemic or topical psoralen-ultraviolet A photochemotherapy within four weeks prior to starting the study.
Subject has received biologic therapy within three months of starting the study.

Sites / Locations

UCSF Psoriasis Skin and Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Dosing

Plaque based dosing

Arm Description

Patients psoriasis to be treated with Excimer laser phototherapy based on conventional dosing guidelines. These guidelines determine the starting dose based on plaque thickness and the skin type of the patient. Patients will also be evaluated for psoriasis plaque response to test doses. The best dose will be selected from a test matrix of doses.

Patients will also be evaluated for psoriasis plaque response to test doses. The best dose will be selected from a test matrix of doses.

Outcomes

Primary Outcome Measures

Modified Psoriasis Area Severity Index

The Modified Psoriasis Area Severity Index is a scale that grades psoriasis based on thickness, redness, scaling, and area involvement.

Secondary Outcome Measures

Full Information

NCT ID

NCT02294981

First Posted

November 14, 2014

Last Updated

June 8, 2020

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT02294981

Brief Title

Excimer Laser Phototherapy Outcomes in the Treatment of Psoriasis

Acronym

Photos

Official Title

A Randomized Clinical Trial to Determine Whether a Novel Plaque-based Dosimetry Strategy Can Improve the Speed of Response to Treatment in Patients With Plaque Psoriasis (Photos)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Terminated

Why Stopped

Protocol was changed to make it easier for treating doctors. No safety concerns

Study Start Date

January 2016 (undefined)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the best dosing strategy when using Excimer Laser to treat plaque-type psoriasis. In this study, half of the body's psoriasis will be treated with a new dosing strategy, and the other half will be treated with the conventional method. We hope to show that the new dosing strategy will result in faster improvement of psoriasis.

Detailed Description

This is a randomized, assessor-blinded clinical trial to determine whether a novel plaque-based dosimetry strategy can improve the speed of response to excimer laser treatment in patients with plaque psoriasis. Each patient will receive plaque-based dosing on one side of the body and conventional dosing on the contralateral side. This design is based on the assumption that psoriasis usually affects patients in a symmetric distribution (e.g., knees and elbows) and the effect of excimer laser phototherapy is limited to the treated plaque. The side of the body treated with plaque-based dosimetry will be assigned using a table of random numbers. The assessor will be blinded to the treatment group. Each patient will be treated 1-2 times per week at the discretion of the investigator for a maximum of 10 treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional Dosing

Arm Type

Active Comparator

Arm Description

Arm Title

Plaque based dosing

Arm Type

Experimental

Arm Description

Patients will also be evaluated for psoriasis plaque response to test doses. The best dose will be selected from a test matrix of doses.

Intervention Type

Device

Intervention Name(s)

Excimer laser phototherapy

Intervention Description

Excimer laser phototherapy is a type of ultraviolet light that is applied to psoriatic plaques. It is administered using a laser in a targeted way so that only the plaques are treated (normal skin is not treated).

Primary Outcome Measure Information:

Title

Modified Psoriasis Area Severity Index

Description

The Modified Psoriasis Area Severity Index is a scale that grades psoriasis based on thickness, redness, scaling, and area involvement.

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of chronic plaque psoriasis for at least 6 months Age ≥ 18 years Body surface area affected ≤ 10 percent Presence of at least one pair of bilateral target lesions with an area of at least 20 cm2 per target lesion. The bilateral target lesions must be present in the same category of anatomical region (e.g., bilateral lower extremities, bilateral upper extremities or bilateral trunk). Exclusion Criteria: active or past history of erythrodermic psoriasis, guttate psoriasis, or pustular psoriasis history of photosensitivity disorder history of malignant melanoma active, invasive non-melanoma skin carcinoma Fitzpatrick Skin Type I Subject has received ultraviolet B phototherapy or any topical anti-psoriatic therapy within two weeks prior to starting the study. Subject has received systemic or topical psoralen-ultraviolet A photochemotherapy within four weeks prior to starting the study. Subject has received biologic therapy within three months of starting the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tina Bhutani, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSF Psoriasis Skin and Treatment Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94118

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Excimer Laser Phototherapy Outcomes in the Treatment of Psoriasis

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