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Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor

Difinsa53 cream is applied to one half of radiation field

Difinsa53

Aquaphor is applied to one half of radiation field

Aquaphor

Joshua Petit, MD

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.

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.

Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

Topical Use of a Silibin-based Cream, Difinsa53™, to Prevent Radiation Dermatitis in Patients With Breast Cancer: A Prospective Study

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.

Poudre Valley Health System

ProTechSure Scientific, Inc.

Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor

Difinsa53: Difinsa53 cream is applied to one half of radiation field

Difinsa53 Arm

Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor

Aquaphor: Aquaphor is applied to one half of radiation field

Aquaphor Arm

Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor

Difinsa53: Difinsa53 cream is applied to one half of radiation field

Aquaphor: Aquaphor is applied to one half of radiation field

Difinsa53 and Aquaphor Arms

Age, Categorical

Participants

Sex: Female, Male

The analysis population consisted of 13 breast cancer patients receiving radiation to a breast. Each breast was divided into two radiation fields, one defined as the Difinsa53 arm and the other as the Aquaphor Arm. Thus each participant contributed data from two fields.

This trial was terminated early, based on minimal radiation dermatitis (scores of 0-1 only in most fields evaluated) that precluded any meaningful analysis of any differing effect in the two treatment arms.

L. Michael Glode, MD

Difinsa 53 Arm

All patients were analyzed by blinded observor

Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria

This radiation field treated with aquaphor

This radiation field treated with Difinsa53

Spots Global Cancer Trial Database for difinsa53

Every month we try and update this database with for difinsa53 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Topical Use of Difinsa53™ to Prevent Radiation Dermatitis	NCT02534129	Radiodermatitis	Difinsa53 Aquaphor	-	ProTechSure Scientific, Inc.
Topical Use of Difinsa53™ to Prevent Radiation Dermatitis	NCT02534129	Radiodermatitis	Difinsa53 Aquaphor	-	ProTechSure Scientific, Inc.
Topical Use of Difinsa53™ to Prevent Radiation Dermatitis	NCT02534129	Radiodermatitis	Difinsa53 Aquaphor	-	ProTechSure Scientific, Inc.

Spots Global Cancer Trial Database for difinsa53

Every month we try and update this database with for difinsa53 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for difinsa53 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.