NCT04479514

Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is examining a preventive skin care regimen for children diagnosed with a brain tumor and receiving anti-cancer therapy with a MEK, Pan-RAF, or BRAF inhibitor.

Detailed description

This prospective, single-arm phase 2 clinical trial is looking at whether gentle skin care, sun protection and dilute bleach baths might decrease the chances or the severity of skin changes that occur during treatment for brain tumors. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive a study treatment regimen that involves a daily sun protection, daily gentle skin care and every-other-day dilute bleach baths for the duration of the study. Participants enrolled in this study, will be in this research study during the course of their anti-cancer treatment and receive skin examinations and complete a survey about their skin condition at the initial visit when anti-cancer treatment is started, at six weeks after the start of anti-cancer treatment, and at twelve weeks after the start of anti-cancer treatment. Participants will be followed for twelve weeks. It is expected that about 20 people will take part in this research study.

Conditions

• Pediatric Cancer
• CNS Tumor, Childhood
• Skin Inflammation

Interventions

Type	Name	Description
OTHER	Warm Baths or Showers	Daily warm baths or showers
OTHER	Moisturizer	moisturizers applied daily immediately after bathing
DRUG	SPF 30 or Higher Suncreen	Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas.
OTHER	Sun Protective Clothing	Sun protective clothing worn when outdoors
BEHAVIORAL	Limited Sun Exposure	Limit sun exposure during peak hours of 10am-4pm
OTHER	Dilute bleach baths	Warm 10-15 minute dilute bleach baths every other day

Timeline

• Start date: 2020-10-01
• Primary completion: 2024-01-01
• Completion: 2025-02-15
• First posted: 2020-07-21
• Last updated: 2025-05-01
• Results posted: 2025-05-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study