Excimer Laser Phototherapy Outcomes in the Treatment of Psoriasis

NCT ID: NCT02294981

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-09-30

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional Dosing

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.

Group Type: ACTIVE_COMPARATOR

Excimer laser phototherapy

Intervention Type: DEVICE

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).

Plaque based dosing

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

Group Type: EXPERIMENTAL

Excimer laser phototherapy

Intervention Type: DEVICE

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).

Interventions

Excimer laser phototherapy

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of chronic plaque psoriasis for at least 6 months

2. Age ≥ 18 years

3. Body surface area affected ≤ 10 percent

4. 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

1. active or past history of erythrodermic psoriasis, guttate psoriasis, or pustular psoriasis

2. history of photosensitivity disorder

3. history of malignant melanoma

4. active, invasive non-melanoma skin carcinoma

5. Fitzpatrick Skin Type I

6. Subject has received ultraviolet B phototherapy or any topical anti-psoriatic therapy within two weeks prior to starting the study.

7. Subject has received systemic or topical psoralen-ultraviolet A photochemotherapy within four weeks prior to starting the study.

8. Subject has received biologic therapy within three months of starting the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tina Bhutani, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Psoriasis Skin and Treatment Center

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14-15201

Identifier Type: -

Identifier Source: org_study_id