Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

Phase 1

Terminated

• Conditions: Radiodermatitis
• Interventions: Drug: Difinsa53; Drug: Aquaphor

• Registration Number: NCT02534129
• Lead Sponsor: ProTechSure Scientific, Inc.

Brief Summary

Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.

Detailed Description

The proposed study seeks to evaluate the efficacy of DIFINISA53™, a safe silibin-based skin cream, on preventing radiation dermatitis (RD) when compared to an over the counter ointment, Aquaphor, in women undergoing radiation therapy for breast cancer following lumpectomy or mastectomy surgery. Presently there is no known fully effective topical protectant from RD and there is no consensus among radiation oncologists on how best to treat RD. This study seeks to identify a more effective option for patients receiving radiation therapy. Each participant will apply the DIFINISA53™ cream to one area of the treated skin and Aquaphor to another area of treated skin. Skin reactions will be evaluated using medical professional assessment, participant assessment, and photographic assessment by a third party.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-27
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2017-04-06
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-04
• Last Update Submitted: 2017-10-04
• Results First Posted: 2017-10-06
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

• Female patients 18 years and older
• Pathologic diagnosis of breast cancer requiring radiation therapy to whole breast
• Able to apply lotion to treatment area at least twice daily during radiation course
• All surgical sites healed
• No evidence of infection
• No history of sensitivity to any component in Aquaphor or Difensa53

Exclusion Criteria

• Prior history of radiation therapy (RT) to that site
• Known dermatologic conditions affecting skin in radiation port
• Concurrent chemotherapy
• Skin infection in radiation port
• History of sensitivity to Aquaphor or Difensa53 component

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Difinsa53	Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor
Single Arm	Aquaphor	Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor

Primary Outcome Measures

Name	Time	Method
Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria	8 weeks	A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria.

Trial Locations

Locations (1)

Poudre Valley Health System; 🇺🇸 Fort Collins, Colorado, United States