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Tests treatment safety and results for Hidradenitis Suppurativa (HS)
Official title The Safety and Efficacy of Roflumilast Foam in HS
ClinicalTrials.gov ID: NCT07263230
What this study is testing
What is Roflumilast 0.3% topical foam?
Roflumilast 0.3% topical foam is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for hidradenitis suppurativa (hs).
Also referred to as ZORYVE.
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
- This study investigates the efficacy of topical roflumilast foam in patients with HS.
- 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 18 and older
You may be able to join if
- Male or female people aged 18 years or older
- Participants are legally competent to sign and give informed consent.
- Diagnosis of HS based on clinical history and physical examination for at least 3 months.
- Diagnosis of HS (Hurley I or II) with a total AN count of at least 4 to ≤ 10, with no draining tunnels at screening and baseline visits with an AN of...
- Agreement to NOT use topical and systemic antibiotics and intralesional steroids for treatment of HS during the study.
You likely can't join if
- people with any medical condition or physical examination abnormality that would prevent study participation or place the subject at significant...
- people who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and...
- Presence of draining tunnels at screening or at baseline visits
- people who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4...
- people with skin conditions other than HS that would interfere with evaluations of the effect of the study medication on HS, as determined by the...
- people with any condition on the treatment area which, in the opinion of the Investigator, could confound how well it works measurements.
See the full eligibility criteria
- Male or female people aged 18 years or older
- Participants are legally competent to sign and give informed consent.
- Diagnosis of HS based on clinical history and physical examination for at least 3 months.
- Diagnosis of HS (Hurley I or II) with a total AN count of at least 4 to ≤ 10, with no draining tunnels at screening and baseline visits with an AN of \>4 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 beach 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 should be at least 3 months post procedure (this applies to deroofing/ marsupialization or excision, not incision \& drainage)
- Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening and Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or...
- Females of non-childbearing potential should be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization (permanent sterilization methods include hysterectomy...
- In good health as judged by the Investigator, based on medical history, targeted physical examination, and vital signs. people and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the...
- people with any medical condition or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator
- people who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (see table of Excluded Medications and Treatments with washout...
- Presence of draining tunnels at screening or at baseline visits
- people who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
- people with skin conditions other than HS that would interfere with evaluations of the effect of the study medication on HS, as determined by the Investigator.
- people with any condition on the treatment area which, in the opinion of the Investigator, could confound how well it works measurements.
- Known allergies to excipients in Roflumilast foam (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphase and ceteth-10...
- people who cannot discontinue the use of systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously for 2 weeks prior to Baseline/Day 1 and during the study period.
- people who have received oral roflumilast (Daxas®, Daliresp®) within 4 weeks prior to Baseline/ Day 1.
- History of severe depression, suicidal ideation or behavior at Baseline/Screening
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Previous treatment with Roflumilast cream or foam (any potency) or current Roflumilast use for any other indication at the baseline visit that would be expected to continue during the trial.
- people with a history of major surgery within 4 weeks prior to Baseline/Day 1 or people who have major surgery planned during the study.
- people with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
- Current or a history of cancer within 5 years except for fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
- Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). people who are unable to communicate, read or understand the local language, or who display another condition, which...
- people who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled people living in the same house.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, 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 - 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.