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NCT02122536 · ClinicalTrials.gov registry record · NA

Split-Face Prospective Study Comparing Botox to Xeomin for the Treatment of Facial Wrinkles

A NA study of Facial Wrinkles, sponsored by YMD Eye and Face.

Completed
Registry status
NA
Development phase
45
Enrollment target
1
Study location

NCT02122536: Completed NA study of Facial Wrinkles, sponsored by YMD Eye and Face.

NCT02122536 is a NA study of Facial Wrinkles that has completed, run by YMD Eye and Face. The registered enrollment target is 45 participants, below the 80-participant average among 6 other Facial Wrinkles trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02122536, a NA study of Facial Wrinkles, has completed, sponsored by YMD Eye and Face.

COMPLETED
Registry status
NA
Development phase
45 participants
Enrollment target
1
Study location

Study Summary

The aim of this prospective, randomized, double-blind, intraindividual split face study will be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial wrinkles using a 1:1 dose ratio.

Primary Outcome

Objective assessment of change in wrinkles score pre and post injection of the crow's feet, glabella, and forehead using the "Validated Assessment Scaled for the Upper Face" published by Flynn et al. 2012. At the end of the study the delta wrinkle score from pre-injection to each followup assessment for each area will be calculated.

Conditions Studied

Interventions

  • DRUG Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects
  • DRUG Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjects

Study Locations (1)

Florida

  • Center for Sight - Sarasota

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2012-07
Est. Completion 2013-11
Phase NA
YMD Eye and Face

1 total trials

What the finished NCT02122536 record still lists

NCT02122536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 80-participant average among 6 other Facial Wrinkles trials with a reported enrollment target (44% lower).

The record links to 1 condition, with Facial Wrinkles appearing as the primary indexed condition, and to 2 interventions - of which Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects is the first listed.

NCT02122536 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT02122536 about?

NCT02122536 is a clinical study titled "Split-Face Prospective Study Comparing Botox to Xeomin for the Treatment of Facial Wrinkles". The aim of this prospective, randomized, double-blind, intraindividual split face study will be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial wrinkles using a 1:1 dose ratio.

What is the current status of trial NCT02122536?

This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2012-07. Estimated completion is 2013-11.

What conditions does trial NCT02122536 study?

This clinical trial studies the following conditions: Facial Wrinkles.

What interventions are being tested in trial NCT02122536?

The interventions under investigation include: Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects (DRUG), Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjects (DRUG).

Who is sponsoring clinical trial NCT02122536?

This trial is sponsored by YMD Eye and Face, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02122536 being conducted?

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

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Source: ClinicalTrials.gov NCT02122536, the US trial registry maintained by the National Library of Medicine. NCT02122536 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.