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Tests treatment safety and results for Hidradenitis Suppurativa
Official title A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT07077902
What this study is testing
What is Topical roflumilast 0.3% foam?
Topical roflumilast 0.3% foam is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for hidradenitis suppurativa.
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 is a phase 2a, open label study. As psoriasis and Hidradenitis Suppurativa (HS) share multiple inflammatory pathways, the investigators hypothesize that the use of topical roflumilast 0.3% foam is a safe and efficacious option as a monotherapy for patients with mild disease and as add-on therapy for maintenance and flares in patients with moderate to severe disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Must understand the risks and the benefits/purpose of the study and provide signed and dated informed consent.
- Must be 18 years at time of signing informed consent form.
- Willing to participate in all required evaluations and procedures in the study including the ability to apply topical medication without difficulty.
- Patients must have a diagnosis of HS based upon the clinical criteria of a history of more than or equal 5 typical lesions (erythematous papules...
- Patients must be candidate for topical therapy defined by active Hurley stage I or Hurley stage II/III with active disease after an adequate trial of...
You likely can't join if
- Concomitant use of topical antibiotics, topical corticosteroids, resorcinol, benzoyl peroxide, vitamin D analogs, Hibiclens wash (except for...
- Increasing or changing dosing for concurrent therapy agents within 90 days before study day 0 and during the study period.
- History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic...
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the...
- Pregnant or breastfeeding.
- Prior major surgery or major life-threatening medical illness within 2 weeks.
See the full eligibility criteria
- Must understand the risks and the benefits/purpose of the study and provide signed and dated informed consent.
- Must be 18 years at time of signing informed consent form.
- Willing to participate in all required evaluations and procedures in the study including the ability to apply topical medication without difficulty.
- Patients must have a diagnosis of HS based upon the clinical criteria of a history of more than or equal 5 typical lesions (erythematous papules, nodules, or abscesses) in flexural sites with a recurring nature over...
- Patients must be candidate for topical therapy defined by active Hurley stage I or Hurley stage II/III with active disease after an adequate trial of systemic antibiotics/hormonal/immunomodulatory or biologic therapy.
- Patient is required to be on stable dose of concomitant therapy for at least 3 months before enrollment and throughout the study period.
- Females of childbearing potential must have a negative urine pregnancy test at baseline visit and be on adequate contraception throughout the study time.
- Concomitant use of topical antibiotics, topical corticosteroids, resorcinol, benzoyl peroxide, vitamin D analogs, Hibiclens wash (except for emollients) within 1 week of enrollment.
- Increasing or changing dosing for concurrent therapy agents within 90 days before study day 0 and during the study period.
- History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major uncontrolled disease.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Pregnant or breastfeeding.
- Prior major surgery or major life-threatening medical illness within 2 weeks.
- Active hepatitis B or C infection with detectible viral nucleic acid in the blood or known Human Immunodeficiency Virus (HIV) positivity.
- Patients with known active malignancy.
- Any severe systemic illness requiring Intravenous (IV) antibiotics within the two weeks prior to initiation of the study drug.
- Active substance abuse or a history of substance abuse within 6 months prior to screening.
- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
The study team makes the final eligibility decision.
Where it's taking place
- Covington, Louisiana, United States
- New Orleans, Louisiana, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Covington, Louisiana, United States; New Orleans, Louisiana, 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.