Hidradenitis Suppurativa study: Roflumilast
Official title Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT07689188
What this study is testing
What is Roflumilast 0.3% topical foam?
An investigational topical foam being studied as a potential treatment for hidradenitis suppurativa. It is designed to inhibit phosphodiesterase‑4 (PDE4), which may reduce inflammatory signaling in the skin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether the topical foam is effective and safe for treating hidradenitis suppurativa.
- Who it's for
- Teenagers and adults who have hidradenitis suppurativa.
- What's involved
- Participants will apply the roflumilast foam to affected skin areas and attend study visits for assessments.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 16 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Male or female people aged 12 years or older at time of consent (or assent).
- Participants and/or legal guardians are legally competent to sign and give informed consent or assent (for adolescents).
- Diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 3 months.
- Diagnosis of HS (Hurley Stage I or II) with a total abscess and inflammatory nodule (AN) count of at least 4 to ≤10, with no draining tunnels at...
- Agreement to NOT use topical and systemic antibiotics and intralesional steroids for treatment of HS during the study.
You likely can't join if
- Medical condition or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by...
- Inability to discontinue prohibited medications or treatments before Baseline or during the study.
- Presence of draining tunnels at Screening or Baseline.
- Unwillingness to refrain from prolonged sun exposure or tanning beds/other artificial light-emitting devices for 4 weeks before Baseline and during...
- Skin conditions other than HS that could interfere with evaluation of study medication.
- Conditions in the treatment area that could confound how well it works measurements.
See the full eligibility criteria
- Male or female people aged 12 years or older at time of consent (or assent).
- Participants and/or legal guardians are legally competent to sign and give informed consent or assent (for adolescents).
- Diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 3 months.
- Diagnosis of HS (Hurley Stage I or II) with a total abscess and inflammatory nodule (AN) count of at least 4 to ≤10, with no draining tunnels at screening and baseline visits, affecting at least one distinct anatomical...
- Agreement to NOT use topical and systemic antibiotics and intralesional steroids for treatment of HS during the study.
- Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study.
- people who have had surgery in the treatment area must be at least 3 months post-procedure (applies to deroofing/marsupialization or excision, not incision and drainage).
- Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline/Day 1 and agree to use at least one highly effective or barrier method of contraception throughout the study.
- Medical condition or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
- Inability to discontinue prohibited medications or treatments before Baseline or during the study.
- Presence of draining tunnels at Screening or Baseline.
- Unwillingness to refrain from prolonged sun exposure or tanning beds/other artificial light-emitting devices for 4 weeks before Baseline and during the study.
- Skin conditions other than HS that could interfere with evaluation of study medication.
- Conditions in the treatment area that could confound how well it works measurements.
- Known allergy to excipients in roflumilast foam.
- Use of oral roflumilast (Daxas® or Daliresp®) within 4 weeks before Baseline.
- History of severe depression, suicidal ideation, or suicidal behavior at Screening/Baseline.
- Pregnant, planning pregnancy during the study, or breastfeeding.
- Previous treatment with roflumilast cream or foam or current roflumilast use for another indication expected to continue during the study.
- Major surgery within 4 weeks before Baseline or planned during the study.
- History of chronic alcohol or drug abuse within 6 months before Screening.
- History of cancer within 5 years, except fully treated basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix.
- Parent(s)/legal guardian(s) or people unable to communicate, read, or understand the local language, or otherwise unsuitable for participation in the Investigator's opinion.
- Family members of the clinical study site, study staff, sponsor, or family members of enrolled people living in the same household.
- Known or suspected severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B or C).
The study team makes the final eligibility decision.
Where it is enrolling
- Missouri City, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Missouri City, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.