N/A N=80 Randomized Other

Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®

Radiodermatitis · Quality of Life

Bottom Line

View on ClinicalTrials.gov: NCT03255980 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Dec 2020

Primary outcome: Primary: Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5 — 10; 5; 13; 11 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Xonrid® gel (Device); Standard of Care (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Helsinn Healthcare SA
Primary completion: Feb 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5	10; 5; 13; 11	—
SECONDARY Median Time to G2 Radiodermatitis Development	—	—
SECONDARY The Proportion of Patients Without G2 Radiation Dermatitis at Week 6 for Both Cancer Sites, at Week 7 for Head & Neck Cancer and 2 Weeks After the Last Radiation for Both Cancer Sites	—	—
SECONDARY The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation	—	—
SECONDARY The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.	—	—
SECONDARY The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation	—	—
SECONDARY The Mean and Worst Score of Skindex-16 Questionnaire	—	—
SECONDARY The Compliance to Experimental Treatment, Assessed Through the Number of Daily Product Applications Reported on the Patient's Diary, Compared to the Amount of Used Product	—	—
SECONDARY The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale	—	—

Summary

To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head & neck cancer patients.

Eligibility Criteria

Inclusion Criteria

Male and female which are 18 years of age or older
Performance status < 2
Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands or breast cancer, planned to receive a total dose of at least 50 Gy
Postoperative or curative radiation treatment
Concurrent chemotherapy is accepted, in head & neck cancer patients
Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the Clinical Investigation Plan tests and procedures.

Exclusion Criteria

Pregnant or lactating women
Planned to receive concurrent cetuximab
Previous radiation therapy on the head and neck area or breast and thorax areas
Cutaneous and connective diseases (i.e. lupus erythematosus or scleroderma)
Systemic diseases known to delay the skin healing process such as diabetes mellitus or severe renal failure
Use of a tissue-equivalent bolus
Use of over-the-counter topical medications containing steroids
Presence of rashes or unhealed wounds in the radiation field
Recent sun exposure
Mental conditions that could adversely affect patients' adherence to the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03255980). 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.