Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

ProTechSure Scientific

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Radiodermatitis

Treatments: Drug: Difinsa53; Drug: Aquaphor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02534129

ProTechSure 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

13 participants in 1 patient group

Single Arm

Experimental group

Description:

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

Treatment:

Drug: Aquaphor

Drug: Difinsa53