Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02168179

KeraStat Skin Therapy in Treating Radiation Dermatitis in Patients With Newly Diagnosed Stage 0-IIIA Breast Cancer

Safety of Treatment With KeraStat Skin Therapy in Breast Cancer Patients Developing Radiation Dermatitis

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This pilot clinical trial studies KeraStat Skin Therapy in treating radiation dermatitis in patients with newly diagnosed stage 0-IIIA breast cancer. Radiation dermatitis is an itchy, painful skin rash that can occur following treatment with radiation. KeraStat Skin Therapy may be a better treatment for radiation dermatitis.

Detailed description

PRIMARY OBJECTIVES: I. To obtain a preliminary estimate the incidence of early adverse skin reaction (EASR) during radiation therapy (RT) and up to two months post RT after the application of the cosmetic cream KeraStat Skin Therapy during RT in breast cancer patients in a pilot study. SECONDARY OBJECTIVES: I. To associate personal characteristics (e.g., race/ethnicity, age, hormone therapy, smoking status, comorbidities, breast size) and treatment characteristics (e.g., RT dose) to incidence of EASR at any time point. OUTLINE: Patients apply KeraStat Skin Therapy topically twice daily (BID) during radiation therapy. After completion of study treatment, patients are followed up at 1 and 2 months.

Conditions

Interventions

TypeNameDescription
PROCEDUREdermatologic complications management/preventionApply KeraStat Skin Therapy topically
OTHERquestionnaire administrationAncillary studies

Timeline

Start date
2014-12-01
Primary completion
2016-07-01
Completion
2016-07-01
First posted
2014-06-20
Last updated
2018-07-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02168179. Inclusion in this directory is not an endorsement.