Psoriasis
Conditions
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.
Interventions
DEVICEExcimer 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).
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
One patient lost to follow-up
Participants by arm
| Arm | Count |
|---|---|
| Conventional Dosing/Plaque Based 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.
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). | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Conventional Dosing/Plaque Based Dosing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 45 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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.
Time frame: 10 weeks
Population: 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.