Participants with Mild to Moderate Hidradenitis Suppurativa Will Receive EVO101 a Topical Cream 0.1% (NCT06645821) | Clinical Trial Compass
RecruitingEarly Phase 1
Participants with Mild to Moderate Hidradenitis Suppurativa Will Receive EVO101 a Topical Cream 0.1%
United States15 participantsStarted 2024-12-03
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to comprehend and willingness to sign a written informed consent form (ICF) for the study.
. Age ≥ 18 years at the time of signing the ICF (informed consent).
. Diagnosis of hidradenitis suppurativa (HS) for at least 3 months prior to the screening visit.
. Mild to moderate HS (hidradenitis suppurativa) at the Baseline Visit (using the HS-PGA/Hidradenitis Suppurativa Physician's Global Assessment scale ).
. Total hidradenitis suppurativa lesion count (abscess, fistulas, nodules, papules, and/or pustules) of at least 5 at the baseline visit.
. Agreement to NOT use topical and/or systemic antibiotics for treatment of HS (hidradenitis suppurativa) for the duration of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The efficacy of EVO101 on hidradenitis suppurativa will be evaluated using two parameters: decrease in lesion count and change in patient reported outcomes (PRO)
Timeframe: 12 Weeks
2
The efficacy of EVO101 on hidradenitis suppurativa will be evaluated using two parameters: decrease in lesion count and change in patient reported outcomes (PRO)
. Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide. Note: Over-the-counter non-medicated soap and water is allowed.
. For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 30 days after the last application of study drug.
Exclusion criteria
. Very severe, severe, minimal, or clear hidradenitis suppurativa Hidradenitis Suppurativa Physician's Global Assessment scale (HS-PGA).
. Women who are pregnant (or who are considering pregnancy) or breastfeeding.
. Subject has uncontrolled, clinically significant comorbidities that make them unsuitable for the clinical trial in the opinion of the investigator.
. Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.
. History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit.
. Use of any of the following medications or treatments within the specified time periods prior to the baseline visit:
. \< 12 weeks or 5 half-lives (whichever is longer)