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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
Enrollment
Sex
Ages
Volunteers
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.
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.
Willing and able to comply with the study protocol and procedures.
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)
< 4 weeks
< 2 weeks
• Other systemic therapies for HS
Retinoids, antihyperglycemics, and antiandrogens, such as acitretin, isotretinoin, metformin, spironolactone, and finasteride) with potential therapeutic impact unless the subject is on a stable dose as defined by the investigator for at least 28 days. There should be no anticipated change of these medications while the subject is on the study.
• Systemic anti-infectives for HS
Antibiotics, antivirals, antifungals
<1 week
Oral or topical PDE4 inhibitor (e.g., apremilast, crisaborole)
Topical JAK inhibitor
Topical anti-infectives for HS lesions
o Antibiotics, antivirals, antifungals
Topical products containing chlorhexidine gluconate, benzoyl peroxide, or topical diluted bleach bath to treat HS. Note: Non-medicated over-the-counter soap and water are not restricted.
Any topical drug applied onto HS lesions
Topical or intralesional corticosteroids o Note: Use of topical corticosteroids for dermatologic diseases other than HS (Hidradenitis Suppurativa)(e.g., atopic dermatitis, psoriasis) is allowed for areas not being treated for HS (Hidradenitis Suppurativa)as long as it is not within 10cm of the areas affected by HS (Hidradenitis Suppurativa).
Inhaled corticosteroids are allowed.
Active participation in an experimental therapy study or who received experimental therapy within 30 days or 5 half-lives (whichever is longer) before Baseline.
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
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Central trial contact
David M Pariser, MD; Danielle L Benedict
Data sourced from clinicaltrials.gov
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