Excimer Laser Phototherapy Outcomes in the Treatment of Psoriasis

NCT02294981 | Terminated Results

• 1 other identifier: 14-15201
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  10 weeks

Study Arms (2)

Conventional Dosing

ACTIVE COMPARATOR

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.

Device: Excimer laser phototherapy

Plaque based dosing

EXPERIMENTAL

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

Device: Excimer laser phototherapy

Interventions

Excimer laser phototherapy 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).

Conventional Dosing; Plaque based dosing

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Psoriasis Skin and Treatment Center

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The sponsor decided to stop the current trial and start a new, larger multi center sponsored study. The results were not analyzed due to termination of study.

Results Point of Contact

• Title: Tina Bhutani
• Organization: UCSF Psoriasis and Skin Treatment Center

psoriasis@ucsf.edu

4159147618

Study Officials

• Tina Bhutani, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 19, 2014
• Study Start: January 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 18, 2020
• Results First Posted: June 18, 2020

Record last verified: 2020-06

Locations

US (1)