Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris

Study Overview
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Brief Summary
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This study examines the effect of Goeckerman therapy (a combination of phototherapy and topical crude coal tar), crude coal tar alone, and phototherapy alone on the immunologic and genetic environment within psoriatic skin lesions.

Detailed Description
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This is a three-arm, open-label study to examine the effect of Goeckerman therapy. Goeckerman therapy is known for its high efficacy and favorable safety profile in the treatment of psoriasis. It consists of a combination of phototherapy and topical crude coal tar). This study will examine how Goeckerman therapy, crude coal tar alone, and phototherapy alone affect the mmunologic and genetic environment within psoriatic skin lesions. Fifteen subjects with moderate to severe psoriasis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to further elucidate the mechanism of action by which Goeckerman treatment improves psoriatic skin lesions.

Official Title
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Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris

Conditions
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Psoriasis Vulgaris, Psoriasis

Intervention / Treatment
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* Other: Goeckerman Therapy
* Drug: Crude Coal Tar Only
* Device: Phototherapy Only


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Male or female ≥ 18 years of age at enrollment. Documentation of predominately moderate to severe plaque psoriasis for at least 6 months prior to enrollment. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Subject is considered a candidate for phototherapy or systemic therapy Body Surface Area (BSA) ≥ 5%. Physical exam within clinically acceptable limits. Exclusion criteria Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. Subject has predominantly non-plaque form of psoriasis. Subject has drug-induced psoriasis. Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy. Patient has absolute or relative contraindication to phototherapy, including photosensitizing disorders. Evidence of abnormality of any immune cell population from a drug-induced or genetic cause. Known HIV positive status. Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Goeckerman Therapy<br>Patients with psoriasis who will receive Goeckerman therapy 5 days per week for 6 weeks. | Other: Goeckerman Therapy<br>* The Goeckerman regimen consists of exposure to narrowband ultraviolet B (NB-UVB) light phototherapy and application of crude coal tar to the skin 5 days per week. The treatment will occur the UCSF outpatient skin treatment center for approximately 4-5 hours, 5 days a week for 6 weeks (total of 30 sessions). The treatment is consistent with the standard of care Goeckerman treatment protocol at UCSF.<br>* Other names: Goeckerman Regimen;|
| Active Comparator: Phototherapy Only<br>Patients with psoriasis who will receive narrowband ultraviolet B (NB-UVB) phototherapy 3 days per week for 12 weeks. | Device: Phototherapy Only<br>* Light treatment with narrowband ultraviolet B (NB-UVB) phototherapy three days per week for 12 weeks at the UCSF Phototherapy Center per the standard UCSF phototherapy protocol, in which starting dose is based on the subject's Fitzpatrick skin type and gradually increased as tolerated. Each phototherapy treatment will last approximately from under 1 minute to less than 15 minutes.<br>* Other names: Light treatment;|
| Active Comparator: Crude Coal Tar Only<br>Patients with psoriasis who will receive skin treatment with crude coal tar only 5 days per week for 6 weeks. | Drug: Crude Coal Tar Only<br>* A topical medication consisting of crude coal tar will be applied to the psoriatic skin under plastic wrap occlusion for approximately up to 4-5 hours, 5 days a week for 6 weeks (total of 30 sessions), at the outpatient skin treatment center at UCSF.<br>* Other names: Coal tar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of differentially expressed immune cell populations | Perform quantitative analysis of the immunologic and genetic changes in immune cell populations after treatment with traditional Goeckerman (NBUVB + coal tar), coal tar only, and NB-UVB only, at weeks 2, 4, and 12 compared to baseline week 0. The immunologic profiles will be compared between subjects receiving the traditional Goeckerman therapy (NB-UVB + coal tar), coal tar only, and NB-UVB therapy only. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of differentially expressed genes and pathways | Quantify the number of differentially expressed genes in each cell population by RNA-sequencing at weeks 0, 2, 4, 12 after receiving traditional Goeckerman therapy (NB-UVB + coal tar), coal tar only, and NB-UVB therapy only. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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goeckerman, phototherapy, psoriasis