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NCT04172922 · ClinicalTrials.gov registry record · Phase 1
Topical Rapamycin/Sirolimus for Complicated Vascular Anomalies and Other Susceptible Lesions
A Phase 1 study, sponsored by Nemours Children's Clinic.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT04172922 is a Phase 1 study that was terminated before completion, run by Nemours Children's Clinic. The registered enrollment target is 5 participants.
The verdict
NCT04172922, a Phase 1 study, was terminated before completion, sponsored by Nemours Children's Clinic.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Proposed Study: Treatment protocol for the use of the topical Rapamycin/Sirolimus for Complicated Vascular Anomalies and other susceptible lesions 1. Aim The aim of this treatment study is to evaluate the benefit and tolerability of topical sirolimus applied to cutaneous vascular anomalies in pediatric patients. The primary end point will be individually determined based on improvement in lesional clinical characteristics over baseline 2. Rationale for topical sirolimus use in VA The rationale for the use of topical sirolimus is to minimize these potential side effects and risks. Data for the use of topical sirolimus for vascular anomalies at this time are anecdotal and case reports only. As such, this prospective protocol seeks to determine the effectiveness and tolerability of topical sirolimus on patients with vascular anomalies that have a cutaneous component. 3. Experimental design This is an open-labeled efficacy trial with the aim to determine if topical sirolimus can be safe and efficacious in treating the cutaneous component of complicated vascular anomalies. Patients who meet eligibility criteria with a diagnosis of vascular anomaly (VA) with cutaneous component will be offered treatment with the investigational topical sirolimus. Patients will receive topical sirolimus therapy for a total of six months and will be monitored regularly at the research site for clinical response. Response will be based on pre-determined clinical criteria. Patients will be removed from study if there is no response at three months after initiation of therapy. Clinical response will be defined as improvement in measurable parameters defined at the time of initiation of therapy. These include 1. Size of lesions, measured in two parallel longest diameters 2. Flattening of lesion 3. Number of vesicles 4. Episodes of superinfection or bleeding 5. Improvement in pain 4. Drug Information The topical sirolimus formulation will be made at a concentration of 1% siro
Interventions
- DRUG Topical Sirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-04-01 |
| Est. Completion | 2024-02-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04172922
The ClinicalTrials.gov registry entry for NCT04172922 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Topical Sirolimus is the first listed.
NCT04172922 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04172922 about?
NCT04172922 is a clinical study titled "Topical Rapamycin/Sirolimus for Complicated Vascular Anomalies and Other Susceptible Lesions". Proposed Study: Treatment protocol for the use of the topical Rapamycin/Sirolimus for Complicated Vascular Anomalies and other susceptible lesions 1. Aim The aim of this treatment study is to evaluate the benefit and tolerability of topical sirolimus applied to cutaneous vascular anomalies in pedia...
What is the current status of trial NCT04172922?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2020-04-01. Estimated completion is 2024-02-15.
What interventions are being tested in trial NCT04172922?
The interventions under investigation include: Topical Sirolimus (DRUG).
Who is sponsoring clinical trial NCT04172922?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
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