Participants with Mild to Moderate Hidradenitis Suppurativa Will Receive EVO101 a Topical Cream 0.1%

Last updated: December 5, 2024
Sponsor: Virginia Clinical Research, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Scalp Disorders

Rosacea

Acne Inversa

Treatment

EVO101

Clinical Study ID

NCT06645821
EVO101-HS001
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ability to comprehend and willingness to sign a written informed consent form (ICF)for the study.

  2. Age ≥ 18 years at the time of signing the ICF (informed consent).

  3. Diagnosis of hidradenitis suppurativa (HS) for at least 3 months prior to thescreening visit.

  4. Mild to moderate HS (hidradenitis suppurativa) at the Baseline Visit (using theHS-PGA/Hidradenitis Suppurativa Physician's Global Assessment scale ).

  5. Total hidradenitis suppurativa lesion count (abscess, fistulas, nodules, papules,and/or pustules) of at least 5 at the baseline visit.

  6. Agreement to NOT use topical and/or systemic antibiotics for treatment of HS (hidradenitis suppurativa) for the duration of the study.

  7. Agreement to NOT use a diluted bleach bath or topical antiseptic washes containingchlorhexidine gluconate or benzoyl peroxide. Note: Over-the-counter non-medicatedsoap and water is allowed.

  8. For women of childbearing potential: agree to remain abstinent (refrain fromheterosexual intercourse) or use a highly effective contraceptive method during thetreatment period and for at least 30 days after the last application of study drug.

  • A woman of childbearing potential is defined as a postmenarcheal female, whohas not reached a postmenopausal state (≥ 12 continuous months of amenorrheawith no identified cause other than menopause) and has not undergone surgicalsterilization (removal of ovaries and/or uterus).

  • The following are highly effective contraceptive methods: combined (estrogenand progestogen containing) hormonal contraception (oral, intravaginal,transdermal) associated with inhibition of ovulation, progestogen-only hormonalcontraception (oral, injectable, implantable) associated with inhibition ofovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence.The reliability of sexual abstinence should be evaluated in relation to theduration of the clinical trial and the preferred and usual lifestyle of thesubject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, orpost-ovulation methods) and withdrawal are not acceptable methods ofcontraception. Females must agree not to donate ova during the study and for 30days after the end of study visit.

  1. Willing and able to comply with the study protocol and procedures.

Exclusion

Exclusion Criteria:

  1. Very severe, severe, minimal, or clear hidradenitis suppurativa HidradenitisSuppurativa Physician's Global Assessment scale (HS-PGA).

  2. Women who are pregnant (or who are considering pregnancy) or breastfeeding.

  3. Subject has uncontrolled, clinically significant comorbidities that make themunsuitable for the clinical trial in the opinion of the investigator.

  4. Have undergone significant trauma or major surgery (per investigator's assessment)within 30 days preceding the screening visit.

  5. History of clinically significant (per investigator's judgment) drug or alcoholabuse within 6 months preceding the screening visit.

  6. Use of any of the following medications or treatments within the specified timeperiods prior to the baseline visit:

  7. < 12 weeks or 5 half-lives (whichever is longer)

  • Investigational or experimental treatments.
  • Immunomodulating biologic drugs
  1. < 4 weeks
  • Systemic JAK inhibitors.
  • Systemic immunosuppressive or immunomodulating small-molecule drugs (eg,corticosteroids [oral or intravenous], avacopan, IRAK4 inhibitors,methotrexate, cyclosporine, dapsone, azathioprine).
  • Surgical, laser, or any phototherapy intervention in areas with HS lesions
  1. < 2 weeks • Other systemic therapies for HS
  • Retinoids, antihyperglycemics, and antiandrogens, such as acitretin,isotretinoin, metformin, spironolactone, and finasteride) with potentialtherapeutic impact unless the subject is on a stable dose as defined bythe investigator for at least 28 days. There should be no anticipatedchange of these medications while the subject is on the study. • Systemic anti-infectives for HS
  • Antibiotics, antivirals, antifungals
  1. <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, ortopical diluted bleach bath to treat HS. Note: Non-medicatedover-the-counter soap and water are not restricted.
  • Any topical drug applied onto HS lesions
  • Topical or intralesional corticosteroids o Note: Use of topicalcorticosteroids for dermatologic diseases other than HS (HidradenitisSuppurativa)(e.g., atopic dermatitis, psoriasis) is allowed for areas notbeing 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.
  1. Active participation in an experimental therapy study or who received experimentaltherapy within 30 days or 5 half-lives (whichever is longer) before Baseline.

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: EVO101
Phase: 1
Study Start date:
December 03, 2024
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

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