An Open-label, Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Subjects With Cutaneous Adverse Events Due to Checkpoint Inhibitors
NCT07639840 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-06-10
Summary
To assess the safety and efficacy of QD 0.3% topical roflumilast foam in patients with cutaneous adverse events due to checkpoint inhibitors over 16 weeks, with or without previous treatment.
Conditions
- Immune-related Dermatitis
Interventions
- DRUG
-
Roflumilast 0.3% topical foam
QD treatment with roflumilast 0.3% foam
Sponsors & Collaborators
-
Massachusetts General Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2027-08-01
- Completion
- 2027-11-01
- FDA Drug
- Yes
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