Is NCT07263230 recruiting in Boston, MA?

Yes, NCT07263230 is currently recruiting participants at its Boston, MA location. This hidradenitis suppurativa (hs) clinical trial is actively enrolling qualified participants.

How do I join the hidradenitis suppurativa (hs) clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Hidradenitis Suppurativa (HS) Clinical Trial in Boston, MA

Who Can Participate

Inclusion Criteria

Male or female subjects 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.

Subjects 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 barrier method of contraception throughout the trial. The use of abstinence as a contraceptive measure is acceptable if this is a consistent part of a lifestyle choice and an acceptable backup method has been identified if the subject becomes sexually active.

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, bilateral oophorectomy, hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy).

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) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria

Subjects 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

Subjects 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 timelines).

Presence of draining tunnels at screening or at baseline visits

Subjects 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.

Subjects 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.

Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy 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 phosphate).

Subjects 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.

Subjects 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.

Subjects with a history of major surgery within 4 weeks prior to Baseline/Day 1 or subjects who have major surgery planned during the study.

Subjects 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). Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.

Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT07263230) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hidradenitis Suppurativa (HS) Treatment Options in Boston, MA

If you're searching for hidradenitis suppurativa (hs) treatment options in Boston, MA, this clinical trial (NCT07263230) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hidradenitis suppurativa (hs) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hidradenitis suppurativa (hs) clinical trials near you to find additional studies recruiting in your area.

Hidradenitis Suppurativa (HS) Clinical Trial in Boston, MA

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