Actively Recruiting
Open-label Proof of Concept Trial Evaluating EVO101 Topical Cream 0.1% in Adults with Mild to Moderate Hidradenitis Suppurativa
Led by Virginia Clinical Research, Inc. · Updated on 2024-12-11
15
Participants Needed
1
Research Sites
8 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
Researchers are evaluating the drug EVO101 to see if it can treat mild to moderate hidradenitis suppurativa (HS) in adults. The study aims to find out if EVO101 reduces the total number of skin lesions and how participants report changes in their HS symptoms. This early-phase clinical trial is open-label, meaning all participants will receive the study drug, and it is conducted at a single site. Participants will apply EVO101 topical cream at a concentration of 0.1% directly to affected areas. The treatment period lasts 12 weeks, during which participants will visit the clinic four times, or five times plus one phone call if the first two visits are separate. All participants receive the same open-label treatment without a comparison group. Throughout the study, participants will keep a dosing diary to track their treatment use. Researchers will monitor lesion counts and collect patient-reported outcome questionnaires to measure changes in HS symptoms. The study includes safety monitoring and adherence checks over the 12-week period to assess the effects of EVO101 on hidradenitis suppurativa.
CONDITIONS
Brief 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
- Age 18 years or older
- Diagnosis of hidradenitis suppurativa for at least 3 months
- Mild to moderate hidradenitis suppurativa at baseline
- At least 5 total hidradenitis suppurativa lesions at baseline
- Agreement to avoid topical and systemic antibiotics during the study
- Agreement to avoid bleach baths and certain antiseptic washes during the study
- For women of childbearing potential: use effective contraception or abstain during treatment and for 30 days after
- Willing and able to follow study procedures
You will not qualify if you...
- Very severe, severe, minimal, or clear hidradenitis suppurativa
- Pregnant or breastfeeding women
- Uncontrolled significant medical conditions
- Major surgery or trauma within 30 days before screening
- Significant drug or alcohol abuse within 6 months
- Use of investigational, biologic, immunosuppressive, or certain systemic treatments within defined timeframes before baseline
- Use of topical treatments or corticosteroids near HS lesions within 1 week before baseline
- Participation in another experimental therapy study within 30 days before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants will receive EVO101 topical cream 0.1% to treat mild to moderate hidradenitis suppurativa.
Weekly visits for up to 12 weeks
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
D
Danielle L Benedict
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here