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NCT02191748 · ClinicalTrials.gov registry record · Phase 2

Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo

A Phase 2 study, sponsored by Rutgers, The State University of New Jersey.

Terminated
Registry status
Phase 2
Development phase
22
Enrollment target

NCT02191748 is a Phase 2 study that was terminated before completion, run by Rutgers, The State University of New Jersey. The registered enrollment target is 22 participants.

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The verdict

NCT02191748, a Phase 2 study, was terminated before completion, sponsored by Rutgers, The State University of New Jersey.

TERMINATED
Registry status
Phase 2
Development phase
22 participants
Enrollment target

Study Summary

Vitiligo is an autoimmune cutaneous disorder that destroys melanocytes leading to depigmented areas of skin. In the United States, vitiligo affects 1% of patients, causing not only changes in the color of skin, but also significant cosmetic concerns and quality of life issues. Current treatment modalities, which include topical corticosteroids, intralesional corticosteroids, phototherapy, and systemic immunosuppression, are variably effective in inducing repigmentation. Unfortunately, some cases of vitiligo are refractory to treatment. There is a need for new, effective modalities to treat patients with otherwise refractory vitiligo. Needling is an office based procedure that theoretically transposes healthy, pigmented skin cells to depigmented areas using a needle in vitiligo patients. Two preliminary studies of needling as a novel treatment for vitiligo had promising results but were limited by small sample size and subjective results. The proposed randomized control trial (RCT) will further investigate the use of needling to treat vitiligo. It differs from the previous studies in that it seeks to identify the cause of clinical benefit by comparing needling alone to needling with corticosteroid, examines a larger number of patients, and quantifies improvement using confocal microscopy. Confocal microscopy (CFM) allows non-invasive visualization of the skin on a cellular level and has been used in the past to diagnose cutaneous pigmentary conditions. This study would be the first RCT of needling in vitiligo to use an objective measure to quantify results, thus has the potential to establish needling as a novel, effective treatment for vitiligo and to evaluate the utility of CFM for monitoring response to treatment.

Interventions

  • DRUG Triamcinolone
  • PROCEDURE Needling

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2014-09
Est. Completion 2018-01
Phase Phase 2

What the Registry Record Tells You About NCT02191748

The ClinicalTrials.gov registry entry for NCT02191748 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Triamcinolone is the first listed.

NCT02191748 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02191748 about?

NCT02191748 is a clinical study titled "Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo". Vitiligo is an autoimmune cutaneous disorder that destroys melanocytes leading to depigmented areas of skin. In the United States, vitiligo affects 1% of patients, causing not only changes in the color of skin, but also significant cosmetic concerns and quality of life issues. Current treatment moda...

What is the current status of trial NCT02191748?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2014-09. Estimated completion is 2018-01.

What interventions are being tested in trial NCT02191748?

The interventions under investigation include: Triamcinolone (DRUG), Needling (PROCEDURE).

Who is sponsoring clinical trial NCT02191748?

This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.