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

NCT03255980 | Completed Results

• 1 other identifier: HD01-16-30
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Radiodermatitis; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5

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

  5 weeks over 7 weeks

Secondary Outcomes (8)

• Median Time to G2 Radiodermatitis Development

  5 weeks over 7 weeks

• 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

  5 weeks over 7 weeks

• The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation

  6 weeks over 7 weeks

• The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.

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

• The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation

  weekly during teratment (7 weeks)

Study Arms (2)

Xonrid®

EXPERIMENTAL

Xonrid® is a medical device for radiation dermatitis

Device: Xonrid® gel; Other: Standard of Care

Standard of Care

ACTIVE COMPARATOR

Standard of care suggested by MASCC guidelines

Device: Xonrid® gel

Interventions

Xonrid® gel DEVICE

Water based gel for the management of toxicity skin symptoms induced by Radiotherapy

Standard of Care; Xonrid®

Standard of Care OTHER

Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines

Xonrid®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helsinn Healthcare SA: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

MeSH Terms

Conditions

Radiodermatitis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Fabio Macchi
• Organization: Helsinn Healthcare SA

fabio.macchi@helsinn.com

0041919852121

Study Officials

• Orlandi Ester, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: MONOCENTER, OPEN LABEL CLINICAL INVESTIGATION

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: August 21, 2017
• Study Start: June 15, 2017
• Primary Completion: February 20, 2019
• Study Completion: January 22, 2020
• Last Updated: December 16, 2020
• Results First Posted: December 16, 2020

Record last verified: 2020-01

Locations

IT (1)