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NCT04087629 · ClinicalTrials.gov registry record · NA

StrataCTX® as a Steroid Sparing Device

A NA study of CTCL, sponsored by Columbia University.

Recruiting
Registry status
NA
Development phase
70
Enrollment target
1
Study location

NCT04087629: Recruiting NA study of CTCL, sponsored by Columbia University.

NCT04087629 is a NA study of CTCL that is actively recruiting participants, run by Columbia University. The registered enrollment target is 70 participants, above the 59-participant average among 4 other CTCL trials with a reported enrollment target (19% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04087629, a NA study of CTCL, is actively recruiting participants, sponsored by Columbia University.

RECRUITING
Registry status
NA
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

The purpose is to determine if StrataCTX® can be used as a steroid sparing agent for the treatment of cutaneous reactions related to, cutaneous T Cell lymphoma (CTCL) and chemotherapy/immunotherapy treatments than the current standard treatment - topical steroids - in people who are receiving treatment for CTCL, or chemotherapy/immunotherapy for solid/hematologic malignancies. Subjects will have CTCL and are being treated with topical steroids, or being treated with chemotherapy/immunotherapy for another condition and have had cutaneous reactions that have warranted initiation of topical steroids.

Primary Outcome

The primary objective of this study is to determine whether StrataCTX® gel is effective as a supportive therapy for cutaneous reactions treated with topical steroids as the standard of care. This objective will be measured by the Pruritus Visual Analogue Scale, which measures self-reported itching on a scale of 0 (no itching) (better outcome) to 10 (worst imaginable itch).

Conditions Studied

Interventions

  • DEVICE StrataCTX® gel

Study Locations (1)

New York

  • Columbia University Irving Medical Center - New York

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2021-07-07
Est. Completion 2026-08
Phase NA
Columbia University

958 total trials

What NCT04087629 shows while recruiting

NCT04087629 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 59-participant average among 4 other CTCL trials with a reported enrollment target (19% higher).

The record links to 1 condition, with CTCL appearing as the primary indexed condition, and to 1 intervention - of which StrataCTX® gel is the first listed.

NCT04087629 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT04087629 about?

NCT04087629 is a clinical study titled "StrataCTX® as a Steroid Sparing Device". The purpose is to determine if StrataCTX® can be used as a steroid sparing agent for the treatment of cutaneous reactions related to, cutaneous T Cell lymphoma (CTCL) and chemotherapy/immunotherapy treatments than the current standard treatment - topical steroids - in people who are receiving treatm...

What is the current status of trial NCT04087629?

This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2021-07-07. Estimated completion is 2026-08.

What conditions does trial NCT04087629 study?

This clinical trial studies the following conditions: CTCL.

What interventions are being tested in trial NCT04087629?

The interventions under investigation include: StrataCTX® gel (DEVICE).

Who is sponsoring clinical trial NCT04087629?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04087629 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04087629, the US trial registry maintained by the National Library of Medicine. NCT04087629 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.