NCT03662685

Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Psoriasis Vulgaris
• Psoriasis

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2018-08-01
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2018-09-07
• Last updated: 2025-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study