Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris
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|ClinicalTrials.gov Identifier: NCT03662685|
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : March 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Vulgaris Psoriasis||Other: Goeckerman Therapy Drug: Crude Coal Tar Only Device: Phototherapy Only||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||November 7, 2020|
|Estimated Study Completion Date :||November 7, 2020|
Active Comparator: Goeckerman Therapy
Patients with psoriasis who will receive Goeckerman therapy 5 days per week for 6 weeks.
Other: Goeckerman Therapy
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.
Active Comparator: Phototherapy Only
Patients with psoriasis who will receive narrowband ultraviolet B (NB-UVB) phototherapy 3 days per week for 12 weeks.
Device: Phototherapy Only
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.
Active Comparator: Crude Coal Tar Only
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
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.
Other Name: Coal tar
- Number of differentially expressed immune cell populations [ Time Frame: 12 weeks ]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.
- Number of differentially expressed genes and pathways [ Time Frame: 12 weeks ]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.
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): NCT03662685
|Contact: Quinn Thibodeaux, MDfirstname.lastname@example.org|
|Contact: Kristen Beck, MDemail@example.com|
|Principal Investigator:||Tina Bhutani, MD||University of California, San Francisco|