Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02251392
Status:
UNKNOWN
Last Update Posted:
2015-12-02
First Post:
2014-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis
Sponsor:
University of Brasilia
Organization:
Study Overview
Official Title:
Evaluation of Therapeutic Efficacy in Use of Chamomila Gel, Chamomila Infuse and Urea in Patients With Breast or Head and Neck Cancer That Developed Radiodermatitis
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
ENROLLING_BY_INVITATION
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:
ChamomillaTH
Brief Summary:
This study aims to evaluate therapeutics interventions in radiodermatitis in patients with breast or head and neck cancer. The data collect is going to begin after determining the better dose in a dose-response curve that is being conduct now in the same institution. To evaluate the skin reaction will be applied scale of the Radiation Therapy Oncology Group (RTOG) - Acute Radiation Morbidity Scoring Criteria, Common Terminology Criteria for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).
Detailed Description:
Hypothesis:
Chamomila gel is more effective than urea (usual care); Chamomila infuse is more effective than urea (usual care); Chamomila gel is more effective than chamomila infuse; Chamomila infuse is more effective than chamomila gel; Chamomila gel is as effective than urea (usual care); Chamomila infuse is as effective than urea (usual care); Chamomila gel is as effective than chamomila infuse; Chamomila infuse is as effective than chamomila gel.
Chamomila gel is more effective than urea (usual care); Chamomila infuse is more effective than urea (usual care); Chamomila gel is more effective than chamomila infuse; Chamomila infuse is more effective than chamomila gel; Chamomila gel is as effective than urea (usual care); Chamomila infuse is as effective than urea (usual care); Chamomila gel is as effective than chamomila infuse; Chamomila infuse is as effective than chamomila gel.
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?: