Recruiting
Phase 2

Roflumilast Foam

Sponsor:

Harrison Dermatology

Code:

NCT07689188

Conditions

Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Roflumilast 0.3% topical foam

Study Details

Brief summary:

This study investigates the efficacy of topical roflumilast foam in patients with HS.

Conditions

Hidradenitis Suppurativa (HS)

Study ID

NCT07689188

Start date

Sep 10, 2026

Status verified date

Oct, 2026

Completion date

Dec 10, 2028

Anticipated

Primary completion date

Mar 10, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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).

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Roflumilast Foam 0.3

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

Interventions

Roflumilast 0.3% topical foam

Roflumilast 0.3% topical foam applied once daily (QD) to all active hidradenitis suppurativa lesions for 16 weeks.

Primary outcome measure

  • Change from Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 [ Time Frame: Baseline and Week 16 ]

Central Contacts and Locations

Central contacts

Harrison P Nguyen, MD, MBA, MPH, FAAD, DTM&H

346.771.3990harrison.nguyen@harrisonderm.com

Locations

Harrison Institute for Clinical Research at Harrison Dermatology

Recruiting

Missouri City, Texas, United States, 77459

Contacts

Principal Investigator:

Harrison P Nguyen, MD, MBA, MPH, FAAD, DTM&H

More Information

Sponsor

Harrison Dermatology

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • HS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Harrison Dermatology on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.