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COMPLETED NA

Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy

NCT04173247 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 28 participants
Start Date 2020-07-27
Est. Completion 2022-10-07
Phase NA

Sponsor

Wake Forest University Health Sciences

1,061 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04173247

The ClinicalTrials.gov registry entry for NCT04173247 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,061 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04173247 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04173247?

The interventions under investigation include: KeraStat Cream (DEVICE), Routine Skin Care - Commercially Available Agents (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04173247?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,061 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial