Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris

University of California San Francisco (UCSF)

Status and phase: Terminated; Phase 1

Conditions: Psoriasis; Psoriasis Vulgaris

Treatments: Device: Phototherapy Only; Other: Goeckerman Therapy; Drug: Crude Coal Tar Only

Study type: Interventional

Funder types: Other

Identifiers

NCT03662685

Goeckerman Immunogenetics

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Male or female ≥ 18 years of age at enrollment.
2. Documentation of predominately moderate to severe plaque psoriasis for at least 6 months prior to enrollment.
3. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
4. Subject is considered a candidate for phototherapy or systemic therapy
5. Body Surface Area (BSA) ≥ 5%.
6. Physical exam within clinically acceptable limits.

Exclusion criteria

1. 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.
2. Subject has predominantly non-plaque form of psoriasis.
3. Subject has drug-induced psoriasis.
4. Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy.
5. Patient has absolute or relative contraindication to phototherapy, including photosensitizing disorders.
6. Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
7. Known HIV positive status.
8. Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 3 patient groups

Goeckerman Therapy

Active Comparator group

Description:

Patients with psoriasis who will receive Goeckerman therapy 5 days per week for 6 weeks.

Treatment:

Other: Goeckerman Therapy

Phototherapy Only

Active Comparator group

Description:

Patients with psoriasis who will receive narrowband ultraviolet B (NB-UVB) phototherapy 3 days per week for 12 weeks.

Treatment:

Device: Phototherapy Only

Crude Coal Tar Only

Active Comparator group

Description:

Patients with psoriasis who will receive skin treatment with crude coal tar only 5 days per week for 6 weeks.

Treatment:

Drug: Crude Coal Tar Only