Hidradenitis Suppurativa (HS)Phase 2ARQ-MA-000260NCT07689188
Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa
A Phase 2 study testing Roflumilast 0.3% topical foam in people with Hidradenitis Suppurativa (HS), run by Harrison Dermatology at 1 site in United States.
Trial summary
This study investigates the efficacy of topical roflumilast foam in patients with HS. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- Roflumilast 0.3% topical foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2026to 10 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects 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 region.
- 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.
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- Subjects 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.
- Females of non-childbearing potential must be premenarchal, postmenopausal (≥12 months spontaneous amenorrhea), or surgically sterile.
- -In good health as judged by the Investigator based on medical history, targeted physical examination, and vital signs. Subjects and parent(s)/legal guardian(s) must be reliable and capable of adhering to the protocol and visit schedule.
Who cannot join
- 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 efficacy measurements.
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- 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 subjects 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 subjects living in the same household.
- Known or suspected severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B or C).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Harrison Institute for Clinical Research at Harrison Dermatology
Missouri City, Texas, 77459
Harrison P Nguyen, MD, 346.771.3990, harrison.nguyen@harrisonderm.com
Research Manager, 346.771.3990, research@harrisonderm.com
About this study
Official title: An Open-Label Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa
This study investigates the efficacy of topical roflumilast foam in patients with HS.
Read the detailed description
Hidradenitis Suppurativa (HS) is a chronic inflammatory skin condition that causes painful and inflamed lumps and abscesses often in the underarms, groin and buttocks. The purpose of this study is to assess the safety and efficacy of QD 0.3% topical roflumilast foam in patients with HS over 16 weeks, with or without previous treatment. The drug involved in this study, 0.3% topical roflumilast foam, is investigational.
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- Roflumilast 0.3% topical foam
- Keywords
- HS
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast 0.3% topical foamDrug
Roflumilast 0.3% topical foam applied once daily (QD) to all active hidradenitis suppurativa lesions for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast Foam 0.3 | Experimental | Experimental: Roflumilast 0.3% topical foam Roflumilast 0.3% topical foam to be applied QD to all active fields for the duration of the 16-week trial.
Interventions:
Drug: Roflumilast 0.3% topical foam Receives: Drug: Roflumilast 0.3% topical foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
Mean change from baseline in the total abscess and inflammatory nodule (AN) count. AN count is the total number of abscesses and inflammatory nodules assessed at baseline and week 16.
Measured: Baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start10 Sep 2026
- Primary completion10 Mar 2028 (estimated)
- Study completion10 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harrison Dermatology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harrison P Nguyen, MD, MBA, MPH, FAAD, DTM&H, Principal investigator, Harrison Dermatology | Harrison Institute for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689188
- Sponsor's protocol ID
- ARQ-MA-000260
- Acronym
- ARQ-MA-000260
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No