Clinical trial NCT03559218: KeraStat(R) Cream for Radiation Dermatitis
Official title: Pilot Study: KeraStat(R) Cream for Radiation Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Dermatitis
Lead sponsor: KeraNetics, LLC
Sponsor class: INDUSTRY
First posted: 2018-06-18
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.

Detailed description: The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.

The secondary objectives are to assess the safety and tolerability of KeraStat Cream in subjects at risk of radiation dermatitis, to assess the effectiveness of KeraStat Cream and how that compares to the current standard of care, and to estimate the amount of KeraStat Cream used per patient and coverage on skin.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 70
2. Female
3. Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more)
4. Able and willing to sign protocol consent form
5. Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
6. Able and willing to have photographs of the affected area taken regularly

Exclusion Criteria:

1. Women who are pregnant, lactating/nursing or plan to become pregnant
2. Previous radiation therapy to the area to be treated with radiation therapy
3. Receiving palliative radiation therapy
4. Unhealed or infected surgical sites in the irradiation area
5. Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
6. Use of oral corticosteroids or topical corticosteroids in the irradiation area
7. Autoimmune disease
8. Skin disease in target irradiation area
9. Known allergy to the standard of care or ingredients in KeraStat Cream

Primary outcomes:
measure: Radiation Therapy Oncology Group Skin Toxicity Scoring
timeFrame: Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.
measure: Dermatology Life Quality Index
timeFrame: Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline (Visit 1), Weekly Visits throughout RT (Visits 2-6), Final Visit approximately 6 weeks post-RT (Visit 7). Subject study duration 8-12 weeks.
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Karen Winfield, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: