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NCT02067260 · ClinicalTrials.gov registry record · NA

A Randomized, Double-blind Clinical Trial to Evaluate the Safety and Efficacy of the X5 HairLaser for the Treatment of Androgenetic Alopecia in Males

A NA study of Androgenetic Alopecia, sponsored by Spencer Forrest.

Completed
Registry status
NA
Development phase
3
Study locations

NCT02067260: Completed NA study of Androgenetic Alopecia, sponsored by Spencer Forrest.

NCT02067260 is a NA study of Androgenetic Alopecia that has completed, run by Spencer Forrest. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02067260, a NA study of Androgenetic Alopecia, has completed, sponsored by Spencer Forrest.

COMPLETED
Registry status
NA
Development phase
3
Study locations

Study Summary

The overall purpose of this clinical investigation is to collect data to support a marketing application for over the counter use of the X5 HairLaser with an indication for hair growth. The goal of this protocol is to demonstrate that the intended users of the X5 HairLaser can safely and effectively perform self-use application by following written instructions.

Primary Outcome

A circular haircount target area approximately 1.9 cm in diameter will be identified between 10 and 2 o'clock in the leading edge of an actively balding area of the vertex. The target area will be clipped short (approximately 1 mm in length). A small dot tattoo will be placed in the center of the target area and will be used as a reference point. The same circular haircount area will be clipped and photographed at subsequent study visits. All hairs \>30 μM will be classified as terminal hairs. T

Conditions Studied

Androgenetic Alopecia

Interventions

  • DEVICE X5 HairLaser
  • DEVICE X5 Hair Laser Sham Device

Study Locations (3)

Arkansas

  • Burke Pharmaceutical Research - Hot Springs

Florida

  • Hilltop Research - St. Petersburg

New York

  • NYU School of Medicine - New York

Trial Details

FieldValue
Phase NA
Spencer Forrest

1 total trials

What the finished NCT02067260 record still lists

NCT02067260 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

The record links to 1 condition, with Androgenetic Alopecia appearing as the primary indexed condition, and to 2 interventions - of which X5 HairLaser is the first listed.

NCT02067260 reports a single indexed study location in Arkansas, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT02067260 about?

NCT02067260 is a clinical study titled "A Randomized, Double-blind Clinical Trial to Evaluate the Safety and Efficacy of the X5 HairLaser for the Treatment of Androgenetic Alopecia in Males". The overall purpose of this clinical investigation is to collect data to support a marketing application for over the counter use of the X5 HairLaser with an indication for hair growth. The goal of this protocol is to demonstrate that the intended users of the X5 HairLaser can safely and effectively...

What is the current status of trial NCT02067260?

This trial is currently completed. It is a NA study.

What conditions does trial NCT02067260 study?

This clinical trial studies the following conditions: Androgenetic Alopecia.

What interventions are being tested in trial NCT02067260?

The interventions under investigation include: X5 HairLaser (DEVICE), X5 Hair Laser Sham Device (DEVICE).

Who is sponsoring clinical trial NCT02067260?

This trial is sponsored by Spencer Forrest, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02067260 being conducted?

This trial has 3 study locations across Arkansas, Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT02067260, the US trial registry maintained by the National Library of Medicine. NCT02067260 (unsized enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.