Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa

Part of paid clinical trials in Missouri City, Texas.

Sponsor
Harrison Dermatology
Study ID
NCT07689188
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Jul 8, 2026
Start date
Aug 10, 2026
Status verified
Jul 2026
Primary completion
Mar 10, 2028
Completion
Dec 10, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Harrison DermatologyMissouri CityTexas77459
Harrison Nguyen, MD, MD
346.771.3990
Amina Caballero, SCRC
346.771.3990
HARRISON NGUYEN, MD (PRINCIPAL_INVESTIGATOR)

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