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Goeckerman Therapy for Psoriasis
Phase 4
Waitlist Available
Led By Tina Bhutani, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial looks at whether Goeckerman therapy, which combines light therapy with coal tar, is more effective than light therapy or coal tar alone in treating psoriasis.
Who is the study for?
This trial is for adults over 18 with moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy. They should have a Body Surface Area (BSA) affected by psoriasis of at least 5% and be able to follow the study's procedures. People with non-plaque psoriasis, drug-induced psoriasis, severe controlled psoriatic arthritis, photosensitivity disorders, immune cell abnormalities, HIV positive status or allergies to local anesthetics cannot participate.
What is being tested?
The study is testing three treatments: Goeckerman Therapy (phototherapy combined with crude coal tar), crude coal tar alone, and phototherapy alone. It aims to understand how these treatments affect the immune system and genes within skin lesions caused by plaque psoriasis.
What are the potential side effects?
Potential side effects may include skin irritation from coal tar application or exposure to UV light during phototherapy. There might also be increased sensitivity to sunlight leading to sunburns if proper care isn't taken after treatment sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of differentially expressed immune cell populations
Secondary study objectives
Number of differentially expressed genes and pathways
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Active Control
Group I: Phototherapy OnlyActive Control1 Intervention
Patients with psoriasis who will receive narrowband ultraviolet B (NB-UVB) phototherapy 3 days per week for 12 weeks.
Group II: Crude Coal Tar OnlyActive Control1 Intervention
Patients with psoriasis who will receive skin treatment with crude coal tar only 5 days per week for 6 weeks.
Group III: Goeckerman TherapyActive Control1 Intervention
Patients with psoriasis who will receive Goeckerman therapy 5 days per week for 6 weeks.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,586 Previous Clinical Trials
15,084,240 Total Patients Enrolled
National Psoriasis FoundationOTHER
11 Previous Clinical Trials
1,867 Total Patients Enrolled
Tina Bhutani, MDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
108 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with HIV.You are being considered for light therapy or medication treatment.You have a large body surface area, more than 5%.You have a type of psoriasis that is mostly not in the form of plaques.You have psoriasis caused by medication.You have a medical condition that makes it unsafe for you to undergo phototherapy, which uses light to treat certain conditions.You have severe psoriatic arthritis that is being well controlled with your current treatment.You have immune system abnormalities caused by medication or genetics.You have had mostly moderate to severe plaque psoriasis for at least 6 months before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Phototherapy Only
- Group 2: Crude Coal Tar Only
- Group 3: Goeckerman Therapy
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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