Safety and efficacy of prophylactic topical steroid application for skin reactions associated with enfortumab vedotin.

JRCT ID: jRCTs051230118

Registered date:27/10/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Urothelial carcinoma
• Date of first enrollment: 14/11/2023
• Target sample size: 12
• Study type: Interventional

Intervention(s)

From the evening before the initiation of the standard EV dose until Day 28, dermovate ointment and Vaseline ointment are applied twice daily in the morning and evening to the right axilla/groin and left axilla/groin, respectively. Vaseline ointment (left side) and dermovate ointment (right side) are applied in that order, 1 FTU (fingertip unit) per site.
After completion of study treatment, continue and initiate application of moisturizers and steroid ointments and reduction of EV for those cases that require it, as in the usual practice.

Outcome(s)

• Primary Outcome: Presence of grade 2 or higher skin reactions according to CTCAE v5.0
• Secondary Outcome: Safety, presence of all grades of skin reactions up to 4 weeks of EV treatment, IGA (investigators global assessment) score on each side of the body at visit date and at discontinuation up to 4 weeks of EV treatment, pain and pruritus scale on each side of the body up to 4 weeks of EV treatment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Male and female patients receiving EV at the standard dose (1.25 mg/kg) for the treatment of unresectable urothelial carcinoma that has progressed after chemotherapy.
2. Patients must be at least 18 years of age at the time of consent.
3. Patients who have given written consent to participate in this study.

Exclude criteria

1. Patients with a history of EV administration.
2. Patients participating in other clinical studies or trials involving interventions within 1 month prior to obtaining consent.
3. Patients treated with systemic steroid therapy (prednisolone equivalent >10 mg/day) within 2 weeks prior to the first dose of EV
4. Patients with an ECOG Performance Status of 3 or higher.
5. Patients with poorly controlled eczema, atopic dermatitis, psoriasis vulgaris, or autoimmune bullous disease.
6. Patients who are judged by the investigators or subinvestigators to be unsuitable for the safe conduct of this study.

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Related Information

• Primary Sponsor: Kita Yuki
• Source(s) of Monetary Support: Astellas Pharma Inc.