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NCT04173247 · ClinicalTrials.gov registry record · NA
Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy
A NA study of Head and Neck Cancer and Radiation Dermatitis, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT04173247: Completed NA study of Head and Neck Cancer and Radiation Dermatitis, sponsored by Wake Forest University Health Sciences.
NCT04173247 is a NA study of Head and Neck Cancer and Radiation Dermatitis that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 28 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04173247, a NA study of Head and Neck Cancer and Radiation Dermatitis, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction (EASR) in patients undergoing radiotherapy to the head and/or neck. Hypothesis: The use of KeraStat Cream in patients receiving radiotherapy for head and neck is feasible, tolerable, and reduces the severity of early adverse skin reaction in the treated region of interest.
Primary Outcome
Feasibility of use of KeraStat Cream is measured by participant compliance with an average of 10 or more applications per week being classified as complaint. In each arm, a 95% confidence interval will be calculated around the estimate of compliance.
Conditions Studied
Interventions
- DEVICE KeraStat Cream
- OTHER Routine Skin Care - Commercially Available Agents
Study Locations (1)
North Carolina
- Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-07-27 |
| Est. Completion | 2022-10-07 |
| Phase | NA |
What the finished NCT04173247 record still lists
NCT04173247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions - of which KeraStat Cream is the first listed.
NCT04173247 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04173247 about?
NCT04173247 is a clinical study titled "Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy". This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction (EASR) in patients undergoing radiotherapy to the head and/or neck. H...
What is the current status of trial NCT04173247?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2020-07-27. Estimated completion is 2022-10-07.
What conditions does trial NCT04173247 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Radiation Dermatitis.
What interventions are being tested in trial NCT04173247?
The interventions under investigation include: KeraStat Cream (DEVICE), Routine Skin Care - Commercially Available Agents (OTHER).
Who is sponsoring clinical trial NCT04173247?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04173247 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04173247's enrollment target sits among peer trials
28 188th of 250 higher than 60 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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