← Back to Search

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

Must not have

History of uncontrolled diabetes

Patients actively receiving whole body phototherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have diabetes that is not well-controlled.

Select...

I am currently undergoing whole body phototherapy.

Select...

I have a history of wounds healing poorly.

Select...

I am currently on medication that weakens my immune system.

Select...

I have a history of skin conditions like psoriasis.

Select...

I have had melanoma in the past.

Select...

I am unable to give consent for myself.

Select...

I have never had tuberculosis, HIV, Hepatitis B, or Hepatitis C.

Select...

I have a heart condition, such as irregular heartbeat or heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To collect and evaluate single-cell multiomics data (RNAseq, CITEseq, TCRseq)

Secondary study objectives

Correlation of protein biomarkers collected by microneedles

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Dupilumab

2017

Completed Phase 4

~11960

Squaric Acid Dibutyl Ester

2017

Completed Phase 1

~40