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

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ClinicalTrials.gov Identifier: NCT02294981
Recruitment Status : Terminated (Protocol was changed to make it easier for treating doctors. No safety concerns)
First Posted : November 19, 2014
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Psoriasis Device: Excimer laser phototherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: 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.
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).

Experimental: Plaque based dosing
Patients psoriasis to be treated with Excimer laser phototherapy based on psoriasis plaque response to test doses. The best dose will be selected from a test matrix of doses.
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).




Primary Outcome Measures :
  1. Modified Psoriasis Area Severity Index [ Time Frame: 10 weeks ]
    The Modified Psoriasis Area Severity Index is a scale that grades psoriasis based on thickness, redness, scaling, and area involvement.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294981


Locations
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United States, California
UCSF Psoriasis Skin and Treatment Center
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Tina Bhutani, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02294981     History of Changes
Other Study ID Numbers: 14-15201
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases