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Corticosteroid

Abrocitinib 200 mg for Chronic Hand Dermatitis

Phase 2

Waitlist Available

Led By Robert Bissonnette, MD

Research Sponsored by Innovaderm Research Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult subject, 18 years of age or older, at the time of consent

Female subject of childbearing potential has had a negative serum pregnancy test at screening and negative urine pregnancy test on Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 2, 4, 12 and 16

Awards & highlights

Study Summary

This trial will test a new drug called abrocitinib to see if it is safe and effective for treating chronic hand eczema. Researchers will also look at how well the drug is tolerated by

Who is the study for?

This trial is for people with moderate to severe chronic hand eczema that hasn't improved with corticosteroid treatments. Participants should have a stable condition and not be planning to change their usual medication routines during the trial.Check my eligibility

What is being tested?

The study tests abrocitinib, an oral medication, at two different doses (100 mg and 200 mg) compared to a placebo. It measures how well the drug works, its safety, and how tolerable it is for patients with hand eczema.See study design

What are the potential side effects?

Abrocitinib may cause side effects like nausea, headache, common cold symptoms or infections. There might also be skin reactions at the pill-taking site or issues related to changes in blood test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am a woman who can have children and have had negative pregnancy tests.

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I have had severe hand eczema for at least 6 months.

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My hand eczema has not improved with treatment.

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My hand eczema is moderate to severe, as confirmed by a doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 2, 4, 12 and 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 2, 4, 12 and 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2, 4, 12 and 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change from baseline in Extent of Disease affected with moderate to severe chronic hand eczema (CHE)

Change from baseline in Hand Eczema Severity Index (HECSI)

Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Abrocitinib 200 mgExperimental Treatment1 Intervention

Abrocitinib at dose 200 mg will be orally administered once daily for 32 weeks.

Group II: Abrocitinib 100 mgExperimental Treatment1 Intervention

Abrocitinib at dose 100 mg will be orally administered once daily for 32 weeks.

Group III: Placebo then abrocitinibPlacebo Group2 Interventions

Placebo will be orally administered once daily for 16 weeks (Part A) then abrocitinib 200 mg will be orally administered once daily for 16 weeks (Part B).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abrocitinib 200 mg

2020

Completed Phase 3

~730

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Innovaderm Research Inc.Lead Sponsor

48 Previous Clinical Trials

3,132 Total Patients Enrolled

1 Trials studying Chronic Hand Dermatitis

9 Patients Enrolled for Chronic Hand Dermatitis

Robert Bissonnette, MDPrincipal InvestigatorInnovaderm Research Inc.

25 Previous Clinical Trials

2,651 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available openings for new participants in this research study?

"As per clinicaltrials.gov, the current status of this trial does not involve participant recruitment. The study was first listed on 4/1/2024 and last updated on 2/21/2024. While this specific trial is inactive in terms of patient enrollment, there are currently 173 other trials open for participation."

Answered by AI

Has the FDA granted approval for Abrocitinib at a dosage of 200 mg?

"Abrocitinib 200 mg is currently being assessed in a Phase 2 trial. The safety evaluation by our team at Power rates it as a 2 on the scale, signifying existing data supporting its safety but lacking evidence for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy

2024. "Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06283550.

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