Trial Outcomes & Findings for Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy (NCT NCT04479514)

Last Updated: 2025-05-01

Results Overview

Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Preventative Skin Care Routine Participants will perform a preventative skin care routine that includes daily sun protection, daily gentle skin care and every-other-day dilute bleach baths for the duration of the study. Participants will 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 treatment, and at twelve weeks after the start of treatment. Warm Baths or Showers: Daily warm baths or showers Moisturizer: moisturizers applied daily immediately after bathing SPF 30 or Higher Suncreen: Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas. Sun Protective Clothing: Sun protective clothing worn when outdoors Limited Sun Exposure: Limit sun exposure during peak hours of 10am-4pm Dilute bleach baths: Warm 10-15 minute dilute bleach baths every other day
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preventative Skin Care Routine n=14 Participants Participants will perform a preventative skin care routine that includes daily sun protection, daily gentle skin care and every-other-day dilute bleach baths for the duration of the study. Participants will 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 treatment, and at twelve weeks after the start of treatment. Warm Baths or Showers: Daily warm baths or showers Moisturizer: moisturizers applied daily immediately after bathing SPF 30 or Higher Suncreen: Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas. Sun Protective Clothing: Sun protective clothing worn when outdoors Limited Sun Exposure: Limit sun exposure during peak hours of 10am-4pm Dilute bleach baths: Warm 10-15 minute dilute bleach baths every other day
Age, Categorical <=18 years	13 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	10.6 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants
Region of Enrollment Canada	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy

Outcome measures

Outcome measures
Measure	Preventative Skin Care Routine n=14 Participants Participants will perform a preventative skin care routine that includes daily sun protection, daily gentle skin care and every-other-day dilute bleach baths for the duration of the study. Participants will 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 treatment, and at twelve weeks after the start of treatment. Warm Baths or Showers: Daily warm baths or showers Moisturizer: moisturizers applied daily immediately after bathing SPF 30 or Higher Suncreen: Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas. Sun Protective Clothing: Sun protective clothing worn when outdoors Limited Sun Exposure: Limit sun exposure during peak hours of 10am-4pm Dilute bleach baths: Warm 10-15 minute dilute bleach baths every other day
Rate of Cutaneous Reaction	7 Participants

SECONDARY outcome

Timeframe: 12 weeks

Measured by the Common Terminology Criteria for Adverse Events (CTCAE)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Measured by the Overall Dry Skin Score (ODS)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Measured by the Hand-Foot Skin Reaction and Quality of Life Score (HFS-14)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Pediatric Quality of Life Inventory (PedsQL)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Children's Dermatology Life Quality Index (CDLQI)

Outcome measures

Outcome data not reported

Adverse Events

Preventative Skin Care Routine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Huang

DFCI

Phone: 6173558937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place