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Monoclonal Antibodies
Biologic Medications for Skin Inflammation
Phase 2 & 3
Recruiting
Led By John Harris, MD, PhD
Research Sponsored by John Harris
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy adult subjects over the age of 18 years with no skin diseases
Patients with dermatologic conditions such as atopic dermatitis, history of localized non-melanoma, keratinocytic skin cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will study how anti-inflammatory skin therapies work to understand how they can be used to treat skin conditions.
Who is the study for?
This trial is for adults over 18 with skin conditions like eczema or a history of certain non-melanoma skin cancers. UMass Medical School students and employees, including non-English speakers with interpreter support, can join. It's not for pregnant women, those on broad immunosuppressants, with specific skin diseases (like psoriasis), high TB risk, liver disease/alcohol abuse, uncontrolled diabetes, compromised immune systems or poor wound healing.Check my eligibility
What is being tested?
The study tests how inflammation and anti-inflammatory treatments work in the skin using biologic medications like Dupilumab and Guselkumab among others. Participants will undergo procedures such as skin punch biopsy and suction blistering to study the effects of these therapies on inflammatory responses.See study design
What are the potential side effects?
Potential side effects may include reactions at the site of medication application or biopsy such as redness, swelling or pain; systemic reactions might involve headache or fatigue. Each medication has its own profile of possible side effects that will be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and do not have any skin diseases.
Select...
I have skin conditions like eczema or a history of certain skin cancers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To collect and evaluate single-cell multiomics data (RNAseq, CITEseq, TCRseq)
Secondary outcome measures
Correlation of protein biomarkers collected by microneedles
Trial Design
2Treatment groups
Experimental Treatment
Group I: Contact Allergen with Immunomodulator Pre-TreatmentExperimental Treatment14 Interventions
Individuals from Arm 1 (Baseline Contact Allergen) who have been exposed to SADBE and/or known patch test allergens followed by skin and blood sampling. These individuals will be pre-treated via administration of a single dose of 1 biologic from the following list: dupilumab, adalimumab, ustekinumab, guselkumab, canakinumab, sarilumab; or a single application of 1 topical steroid from the following list: betamethasone valerate, triamcinolone acetonide, fluticasone propionate. Allergic contact dermatitis will then be induced and the skin sampled.
Group II: Baseline Contact AllergenExperimental Treatment5 Interventions
Individuals who will have allergic contact dermatitis induced via squaric acid dibutyl ester (SADBE) and/or known patch test allergens followed by skin and blood sampling. There is a protocol to sensitize individuals to SADBE if they have not previously been exposed to SADBE.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Squaric Acid Dibutyl Ester
2017
Completed Phase 1
~40
Sarilumab
2020
Completed Phase 3
~5980
Triamcinolone Acetonide
2018
Completed Phase 4
~3730
Dupilumab
2017
Completed Phase 4
~12230
Adalimumab
2013
Completed Phase 4
~6480
Ustekinumab
2013
Completed Phase 4
~4140
Fluticasone Propionate
2011
Completed Phase 4
~3500
Microneedle
2008
Completed Phase 3
~180
Canakinumab
2011
Completed Phase 3
~3090
Betamethasone Valerate
2012
Completed Phase 3
~60
Guselkumab
2015
Completed Phase 4
~5990
Find a Location
Who is running the clinical trial?
John HarrisLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
John Harris, MD, PhDPrincipal InvestigatorUniversity of Massachusetts Chan Medical School
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes that is not well-controlled.You have had patch testing done in a previous clinical trial.I have a history of wounds healing poorly.You have a history of skin that tears easily.I am currently undergoing whole body phototherapy.I do not have current infections, frequent past infections, or a weakened immune system.I am over 18 and do not have any skin diseases.I am currently on medication that weakens my immune system.I have a history of skin conditions like psoriasis.I have had melanoma in the past.You have a high risk of tuberculosis, like if you have been in prison, are from a place where TB is common, or have traveled to a place where TB is common.I have skin conditions like eczema or a history of certain skin cancers.You have had liver problems or drink alcohol excessively.You have had a disease that damages the protective covering of nerve fibers in the past.I am unable to give consent for myself.I don't speak English but can participate with an interpreter and a translated consent form.I have never had tuberculosis, HIV, Hepatitis B, or Hepatitis C.I have a heart condition, such as irregular heartbeat or heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Baseline Contact Allergen
- Group 2: Contact Allergen with Immunomodulator Pre-Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being accepted into this trial?
"Yes, the information on clinicaltrials.gov says that this trial is currently searching for candidates. The trial was initially posted on 9/15/2022 and was last updated on 9/6/2022. The clinical trial is recruiting for 45 patients between 1 sites."
Answered by AI
How many people are the drugs being tested on in this clinical trial?
"The correct, the clinical trial is recruiting patients as of right now. According to information found on clinicaltrials.gov, the study was first posted on September 15th, 2020 and last updated on September 6th, 2020. The research is looking for 45 individuals from 1 location."
Answered by AI
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