Trial Outcomes & Findings for Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid® (NCT NCT03255980)

NCT ID: NCT03255980

Last Updated: 2020-12-16

Results Overview

The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis \< G2) at week 5

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: 5 weeks over 7 weeks
• Results posted on: 2020-12-16

Participant Flow

FPI: June 2017 LPO: July 2018

Participant milestones

Measure	Breast Cancer Group: Xonrid+SOC Patients treated with the device under evaluation and according to MASCC guidelines	Breast Cancer Group: SOC Patients treated with Standard of Care according to MASCC guidelines	Head and Neck Cancer Group: Xonrid + SOC H\&N Patients treated with the device under evaluation and according to MASCC guidelines	Head and Neck Cancer Group: SOC H\&N Cancer Patients treated with Standard of Care according to MASCC guidelines
Overall Study STARTED	20	20	20	20
Overall Study COMPLETED	17	12	14	8
Overall Study NOT COMPLETED	3	8	6	12

Reasons for withdrawal

Measure	Breast Cancer Group: Xonrid+SOC Patients treated with the device under evaluation and according to MASCC guidelines	Breast Cancer Group: SOC Patients treated with Standard of Care according to MASCC guidelines	Head and Neck Cancer Group: Xonrid + SOC H\&N Patients treated with the device under evaluation and according to MASCC guidelines	Head and Neck Cancer Group: SOC H\&N Cancer Patients treated with Standard of Care according to MASCC guidelines
Overall Study Grade =>3 Skin Toxicity	1	4	6	5
Overall Study Adverse Event	1	1	0	1
Overall Study Lack of compliance to study or assessmen	0	1	0	0
Overall Study Lost to Follow-up	1	1	0	3
Overall Study Withdrawal by Subject	0	1	0	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Breast Cancer Group: Xonrid+SOC n=20 Participants Patients treated with the device under evaluation and according to MASCC guidelines	Breast Cancer Group: SOC n=20 Participants Patients treated with Standard of Care according to MASCC guidelines	Head and Neck Cancer Group: Xonrid + SOC n=20 Participants H\&N Patients treated with the device under evaluation and according to MASCC guidelines	Head and Neck Cancer Group: SOC n=20 Participants H\&N Cancer Patients treated with Standard of Care according to MASCC guidelines	Total n=80 Participants Total of all reporting groups
Age, Continuous	49.56 years STANDARD_DEVIATION 4.80 • n=5 Participants	49.01 years STANDARD_DEVIATION 4.54 • n=7 Participants	55.73 years STANDARD_DEVIATION 12.46 • n=5 Participants	59.49 years STANDARD_DEVIATION 12.34 • n=4 Participants	53.45 years STANDARD_DEVIATION 8.52 • n=21 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	48 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	16 Participants n=5 Participants	16 Participants n=4 Participants	32 Participants n=21 Participants
Race/Ethnicity, Customized	20 Caucasian n=5 Participants	20 Caucasian n=7 Participants	20 Caucasian n=5 Participants	20 Caucasian n=4 Participants	80 Caucasian n=21 Participants
Region of Enrollment Italy	20 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants	20 participants n=4 Participants	80 participants n=21 Participants

PRIMARY outcome

Timeframe: 5 weeks over 7 weeks

The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis < G2) at week 5

Outcome measures

Measure	Breast Cancer Group: Xonrid+SOC n=18 Participants Patients treated with the device under evaluation and according to MASCC guidelines	Breast Cancer Group: SOC n=18 Participants Patients with Breast Cancer treated with Standard of Care according to MASCC guidelines	Head and Neck Cancer Group: Xonrid + SOC n=20 Participants H\&N Patients treated with the device under evaluation and according to MASCC guidelines	Head and Neck Cancer Group: SOC n=16 Participants H\&N Cancer Patients treated with Standard of Care according to MASCC guidelines
Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5	10 participants	5 participants	13 participants	11 participants

SECONDARY outcome

Timeframe: 5 weeks over 7 weeks

Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks over 7 weeks

Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks over 7 weeks

Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation for both cancer sites, at week 7 for head & neck cancer and 2 weeks after the last radiation for both cancer sites.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Follow-up: 2 weeks after the completion of radiation treatment

The changes in skin erythema and pigmentation, according to the ITA (individual Typological Angle) degrees measured throughout the study by the Investigators.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: weekly during teratment (7 weeks)

Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks over 7 weeks

Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks over 7 weeks

Compliance is based on the total amount ( weight) of Xonrid used over the treatment period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks over 7 weeks

Global patient's satisfaction recorded by the Linkert Scale

Outcome measures

Outcome data not reported

Adverse Events

Breast Cancer: Xonrid® +SOC

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Breast Cancer: Standard Of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Head and Neck Cancer: Xonrid + SOC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Head and Neck Cancer: Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Breast Cancer: Xonrid® +SOC n=20 participants at risk Xonrid® is a medical device for radiation dermatitis Xonrid® gel: Water based gel for the management of toxicity skin symptoms induced by Radiotherapy Standard of Care: Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines	Breast Cancer: Standard Of Care n=20 participants at risk Standard of care suggested by MASCC guidelines	Head and Neck Cancer: Xonrid + SOC n=20 participants at risk Xonrid® is a medical device for radiation dermatitis Xonrid® gel: Water based gel for the management of toxicity skin symptoms induced by Radiotherapy Standard of Care: Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines	Head and Neck Cancer: Standard of Care n=20 participants at risk Standard of care suggested by MASCC guidelines
Skin and subcutaneous tissue disorders pruritus	5.0% 1/20 • Number of events 1 • 13 months	0.00% 0/20 • 13 months	0.00% 0/20 • 13 months	0.00% 0/20 • 13 months

Other adverse events

Measure	Breast Cancer: Xonrid® +SOC n=20 participants at risk Xonrid® is a medical device for radiation dermatitis Xonrid® gel: Water based gel for the management of toxicity skin symptoms induced by Radiotherapy Standard of Care: Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines	Breast Cancer: Standard Of Care n=20 participants at risk Standard of care suggested by MASCC guidelines	Head and Neck Cancer: Xonrid + SOC n=20 participants at risk Xonrid® is a medical device for radiation dermatitis Xonrid® gel: Water based gel for the management of toxicity skin symptoms induced by Radiotherapy Standard of Care: Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines	Head and Neck Cancer: Standard of Care n=20 participants at risk Standard of care suggested by MASCC guidelines
Infections and infestations Ear Infection	5.0% 1/20 • Number of events 1 • 13 months	0.00% 0/20 • 13 months	0.00% 0/20 • 13 months	0.00% 0/20 • 13 months

Additional Information

Dr. Fabio Macchi

Helsinn Healthcare SA

Phone: 0041919852121

Email: fabio.macchi@helsinn.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place