Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03662685
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of California, San Francisco
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tina Bhutani, MD
Principal Investigator Affiliation University of California, San Francisco
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis Vulgaris, Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Goeckerman Therapy

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

Active Comparator: Phototherapy Only

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

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.

Interventions

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.

Contact a Trial Team

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UCSF Psoriasis and Skin Treatment Center, San Francisco, California

Status

Recruiting

Address

UCSF Psoriasis and Skin Treatment Center

San Francisco, California, 94118

Site Contact

Quinn Thibodeaux, MD

psoriasis@ucsf.edu

415-944-7618

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