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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02294981
Other study ID # 14-15201
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date September 2017

Study information

Verified date June 2020
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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).

Locations

Country Name City State
United States UCSF Psoriasis Skin and Treatment Center San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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