N/A Completed N=28 Randomized Supportive Care

Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy

Head and Neck Cancer · Radiation dermatitis

Source: ClinicalTrials.gov NCT04173247 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Sep 2023

Primary outcomePrimary: Completion Rate of Use of KeraStat Cream — 10; 7 Participants

Summary

This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction (EASR) in patients undergoing radiotherapy to the head and/or neck. Hypothesis: The use of KeraStat Cream in patients receiving radiotherapy for head and neck is feasible, tolerable, and reduces the severity of early adverse skin reaction in the treated region of interest.

Outcome Measures

Outcome	Result	p-value
PRIMARY Completion Rate of Use of KeraStat Cream	10; 7	—
SECONDARY Number of Participants Discontinuing Skin Care Regimen	0; 0	—
SECONDARY Number of Participants With Grade 2+ Radiation Dermatitis	9; 7	—
SECONDARY Number of Participants Reporting Radiation Skin Reaction	8; 10	—
SECONDARY Dermatology Life Quality Index Questionnaire	1.5; 1.9	0.28
SECONDARY Number of Tubes of KeraStat Cream Used to Calculate Skin Coverage	49	—

Eligibility Criteria

Inclusion Criteria

Diagnosis of head and neck cancer planned to receive conventionally-fractionated definitive radiotherapy to the head and neck to a total prescribed dose of at least 60 Gy
Able and willing to sign protocol consent form
Able and willing to complete tolerability and quality of life assessments
Able and willing to have photographs of the affected area taken regularly

Exclusion Criteria

Women who are pregnant, lactating/nursing or plan to become pregnant
Previous radiation therapy to the area to be treated with radiation therapy
Active, medically necessary use of topical corticosteroids in the irradiation area
Active scleroderma or lupus requiring systemic medication
Treatment with anti-EGFR antibodies for head and neck cancer (previously or planned)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04173247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.