Clinical trial NCT02294981: Excimer Laser Phototherapy Outcomes in the Treatment of Psoriasis
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
Overall status: TERMINATED
Phase: NA
Conditions: Psoriasis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Modified Psoriasis Area Severity Index
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Psoriasis Skin and Treatment Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Tina Bhutani, MD
role: PRINCIPAL_INVESTIGATOR
References: