Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT01923220
Status:
UNKNOWN
Last Update Posted:
2013-08-15
First Post:
2013-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis
Sponsor:
HealOr
Organization:
Study Overview
Official Title:
An Open-Label, Randomized Study to Evaluate the Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis In Breast Cancer Patients Undergoing Radiation Therapy.
Status:
UNKNOWN
Status Verified Date:
2013-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARD
Brief Summary:
This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment
Detailed Description:
This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment in addition to sterile water for irrigation applied daily for 15 minutes (with gauze) on treatment fields to create the same cooling effect as in treatment arm 1. Both treatment arms 1\&2 treatments will be applied topically once daily for up to 8 weeks to reduce radiation dermatitis in up to 90 breast cancer patients undergoing adjuvant radiation therapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: