Actively Recruiting
The Safety and Efficacy of Roflumilast Foam in HS
Led by Beth Israel Deaconess Medical Center · Updated on 2026-02-11
20
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study investigates the efficacy of topical roflumilast foam in patients with HS.
CONDITIONS
Official Title
The Safety and Efficacy of Roflumilast Foam in HS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years or older
- Legally competent to sign and give informed consent
- Diagnosis of HS based on clinical history and physical exam for at least 3 months
- HS Hurley stage I or II with abscess and inflammatory nodule (AN) count of 4 to 10
- No draining tunnels at screening and baseline visits
- Agreement to avoid topical and systemic antibiotics and intralesional steroids for HS during the study
- Agreement to avoid diluted bleach baths or antiseptic washes with chlorhexidine gluconate or benzoyl peroxide on affected areas during the study
- Surgery in treatment area must be at least 3 months prior (except incision & drainage)
- Females of childbearing potential must have negative pregnancy tests and use effective contraception or abstinence
- Females of non-childbearing potential must be post-menopausal for at least 12 months or surgically sterilized
- In good health based on medical history, physical exam, and vital signs
- Ability to follow the study protocol and visit schedule
You will not qualify if you...
- Any medical condition or physical exam abnormality that poses significant risk or prevents participation
- Inability to stop prohibited medications and treatments before baseline and during study
- Presence of draining tunnels at screening or baseline
- Unwillingness to avoid prolonged sun exposure and tanning devices 4 weeks before baseline and during study
- Skin conditions other than HS that interfere with study evaluations
- Conditions in treatment area that could confound efficacy assessments
- Known allergies to any excipients in roflumilast foam
- Inability to stop systemic CYP3A4 inhibitors or dual CYP3A4 and CYP1A2 inhibitors 2 weeks before baseline and during study
- Use of oral roflumilast within 4 weeks before baseline
- History of severe depression, suicidal thoughts, or behavior at screening/baseline
- Pregnant, planning pregnancy, or breastfeeding females
- Previous or current use of roflumilast cream or foam
- Major surgery within 4 weeks before baseline or planned during study
- History of chronic alcohol or drug abuse within 6 months before screening
- Current or history of cancer within 5 years except certain skin or cervical cancers
- Inability to communicate, read, or understand the local language
- Family members of study site staff, sponsor, or enrolled subjects living in same household
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
M
Martina Porter, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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