Photos: Excimer Laser Phototherapy Outcomes in the Treatment of Psoriasis
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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. 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
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 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
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).
|
Outcome Measures
Primary Outcome Measures
- Modified Psoriasis Area Severity Index [10 weeks]
The Modified Psoriasis Area Severity Index is a scale that grades psoriasis based on thickness, redness, scaling, and area involvement.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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).
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSF Psoriasis Skin and Treatment Center | San Francisco | California | United States | 94118 |
Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Tina Bhutani, MD, University of California, San Francisco
Study Documents (Full-Text)
More Information
Publications
None provided.- 14-15201
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | One patient lost to follow-up |
| Arm/Group Title | Conventional Dosing/Plaque Based Dosing |
|---|---|
| Arm/Group Description | 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. 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). |
| Period Title: Overall Study | |
| STARTED | 4 |
| COMPLETED | 3 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Conventional Dosing/Plaque Based Dosing |
|---|---|
| Arm/Group Description | 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. 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). |
| Overall Participants | 4 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
4
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
45
|
| Sex: Female, Male (Count of Participants) | |
| Female |
2
50%
|
| Male |
2
50%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
2
50%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
2
50%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
4
100%
|
Outcome Measures
| Title | Modified Psoriasis Area Severity Index |
|---|---|
| Description | The Modified Psoriasis Area Severity Index is a scale that grades psoriasis based on thickness, redness, scaling, and area involvement. |
| Time Frame | 10 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Conventional Dosing/Plaque Based Dosing |
|---|---|
| Arm/Group Description | 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. 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). |
| Measure Participants | 0 |
Adverse Events
| Time Frame | Adverse events were reviewed at each participant visit (once or twice weekly) for the duration of the study (total of 5 months). | |
|---|---|---|
| Adverse Event Reporting Description | No patients reported SAEs, no deaths occurred during this study, no AEs of any type was reported during this study. | |
| Arm/Group Title | Conventional Dosing/Plaque Based Dosing | |
| Arm/Group Description | 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. 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). | |
All Cause Mortality |
||
| Conventional Dosing/Plaque Based Dosing | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | |
Serious Adverse Events |
||
| Conventional Dosing/Plaque Based Dosing | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Conventional Dosing/Plaque Based Dosing | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Tina Bhutani |
|---|---|
| Organization | UCSF Psoriasis and Skin Treatment Center |
| Phone | 4159147618 |
| psoriasis@ucsf.edu |
- 14-15201