Actively Recruiting
Participants with Mild to Moderate Hidradenitis Suppurativa Will Receive EVO101 a Topical Cream 0.1%
Led by Virginia Clinical Research, Inc. · Updated on 2024-12-11
15
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
V
Virginia Clinical Research, Inc.
Lead Sponsor
E
Evommune, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if drug EVO101 works to treat mild to moderate hidradenitis suppurativa in adults. The main questions it aims to answer are: Does drug EVO101 lower the total number of lesion a participant has from the first visit to the last visit. What medical problems do participants have when applying drug EVO101 Does a participant perceive a change in their hidradenitis suppurativa symptoms based on patient reported outcome questionnaires. Participants will: Apply EVO101 topical cream 0.1% topically Visit the clinic four times unless the first and second appointment have to be done separately then there will be five clinic visits and one phone call over a twelve week period. Keep a dosing diary
CONDITIONS
Official Title
Participants with Mild to Moderate Hidradenitis Suppurativa Will Receive EVO101 a Topical Cream 0.1%
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent form
- Age 18 years or older at consent
- Diagnosis of hidradenitis suppurativa for at least 3 months before screening
- Mild to moderate hidradenitis suppurativa at baseline
- At least 5 hidradenitis suppurativa lesions at baseline
- Agree not to use topical or systemic antibiotics for hidradenitis suppurativa during the study
- Agree not to use diluted bleach baths or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide; non-medicated soap and water allowed
- Women of childbearing potential must agree to abstain or use highly effective contraception during treatment and for 30 days after last drug application
- Willing and able to comply with study protocol and procedures
You will not qualify if you...
- Very severe, severe, minimal, or clear hidradenitis suppurativa at baseline
- Pregnant or breastfeeding women
- Uncontrolled, clinically significant comorbidities deemed unsuitable for the study
- Significant trauma or major surgery within 30 days before screening
- History of significant drug or alcohol abuse within 6 months before screening
- Use of investigational or immunomodulating biologic drugs within 12 weeks before baseline
- Use of systemic JAK inhibitors or immunosuppressive drugs within 4 weeks before baseline
- Use of systemic therapies for hidradenitis suppurativa within 2 weeks before baseline unless stable for at least 28 days
- Use of oral or topical PDE4 inhibitors, topical JAK inhibitors, topical anti-infectives, or certain topical corticosteroids within 1 week before baseline
- Active participation in experimental therapy or received experimental therapy within 30 days or 5 half-lives before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23502
Actively Recruiting
Research Team
D
David M Pariser, MD
CONTACT
D
Danielle L Benedict
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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