Trial Outcomes & Findings for Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy (NCT NCT04479514)
NCT ID: NCT04479514
Last Updated: 2026-06-12
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
2026-06-12
Participant Flow
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
| 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=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
10.6 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=9 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 12 weeksProportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy
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 weeksMeasured by the Common Terminology Criteria for Adverse Events (CTCAE), minimum 1 maximum 5 with 5 being the most severe. If patients had a skin reaction, CTCAE was used to gradfe the severity of their reaction. There are no subscales.
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
|
|---|---|
|
Overall Cutaneous Reaction Severity
|
1.3 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 12 weeksMeasured by # of participants with xerosis
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
|
|---|---|
|
Xerosis Incidence
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 weeksMeasured incidence of hand foot syndrome
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
|
|---|---|
|
Hand Foot Syndrome
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksChildren's Dermatology Life Quality Index (CDLQI) is used to measure the impact of skin disease on quality of life. The range of scores is from 0-30 with 30 indicating the greatest impact on quality of life. There are no subscales.
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
|
|---|---|
|
Children's Dermatology Quality of Life
|
2.6 score on a scale
Standard Deviation 6.8
|
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place