Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris

Phase 4

Active, not recruiting

• Conditions: Psoriasis Vulgaris; Psoriasis
• Interventions: Device: Phototherapy Only; Drug: Crude Coal Tar Only; Other: Goeckerman Therapy

• Registration Number: NCT03662685
• Lead Sponsor: University of California, San Francisco

Brief 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.

Study Timeline

• Study First Submitted: 2017-10-05
• Study Start: 2018-08-01
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phototherapy Only	Phototherapy Only	Patients with psoriasis who will receive narrowband ultraviolet B (NB-UVB) phototherapy 3 days per week for 12 weeks.
Crude Coal Tar Only	Crude Coal Tar Only	Patients with psoriasis who will receive skin treatment with crude coal tar only 5 days per week for 6 weeks.
Goeckerman Therapy	Goeckerman Therapy	Patients with psoriasis who will receive Goeckerman therapy 5 days per week for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Number of differentially expressed immune cell populations	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.

Secondary Outcome Measures

Name	Time	Method
Number of differentially expressed genes and pathways	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.

Trial Locations

Locations (1)

UCSF Psoriasis and Skin Treatment Center; 🇺🇸 San Francisco, California, United States