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NCT01269801 · ClinicalTrials.gov registry record · Phase 4

Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds

A Phase 4 study of Wrinkles, sponsored by AboutSkin Dermatology and DermSurgery, PC.

Completed
Registry status
Phase 4
Development phase
156
Enrollment target
3
Study locations

NCT01269801: Completed Phase 4 study of Wrinkles, sponsored by AboutSkin Dermatology and DermSurgery, PC.

NCT01269801 is a Phase 4 study of Wrinkles that has completed, run by AboutSkin Dermatology and DermSurgery, PC. The registered enrollment target is 156 participants, above the 34-participant average among 7 other Wrinkles trials with a reported enrollment target (359% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01269801, a Phase 4 study of Wrinkles, has completed, sponsored by AboutSkin Dermatology and DermSurgery, PC.

COMPLETED
Registry status
Phase 4
Development phase
156 participants
Enrollment target
3
Study locations

Study Summary

The purpose of this study is to see how well Juvederm Ultra XC or Juvederm Ultra Plus XC, and BOTOX Cosmetic, work compared to each other and when used together for the cosmetic treatment of age-associated wrinkles and folds of the face.

Primary Outcome

Assessments at Visits 3,5,6+7 (weeks 4,8,12,24) include: -Physician Global Aesthetic Improvement Scale (PGAIS). Ratings include no change, improved, much improved, very much improved. Number of subjects with improvement score for the 5 point PGAIS from baseline to Visit 7. -Objective Observer Global Aesthetic Improvement Scale Number of subjects with improvement score for the from baseline to Visit 7. Ratings include no change, some improvement, definite improvement, substantial improvement,

Conditions Studied

Interventions

  • DRUG onabotulinumtoxinA
  • DRUG JUVÉDERM

Study Locations (3)

Ontario

  • Niagara Falls Dermantology and Skin Care Center - Niagara Falls
  • University of Toronto - Toronto

Colorado

  • About Skin Dermatology - Englewood

Trial Details

FieldValue
Enrollment Target 156 participants
Start Date 2011-01
Est. Completion 2012-02
Phase Phase 4

What the finished NCT01269801 record still lists

NCT01269801 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, above the 34-participant average among 7 other Wrinkles trials with a reported enrollment target (359% higher).

The record links to 1 condition, with Wrinkles appearing as the primary indexed condition, and to 2 interventions - of which onabotulinumtoxinA is the first listed.

NCT01269801 reports a single indexed study location in Ontario, Colorado.

Frequently Asked Questions

What is clinical trial NCT01269801 about?

NCT01269801 is a clinical study titled "Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds". The purpose of this study is to see how well Juvederm Ultra XC or Juvederm Ultra Plus XC, and BOTOX Cosmetic, work compared to each other and when used together for the cosmetic treatment of age-associated wrinkles and folds of the face.

What is the current status of trial NCT01269801?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 156 participants. The study started on 2011-01. Estimated completion is 2012-02.

What conditions does trial NCT01269801 study?

This clinical trial studies the following conditions: Wrinkles.

What interventions are being tested in trial NCT01269801?

The interventions under investigation include: onabotulinumtoxinA (DRUG), JUVÉDERM (DRUG).

Who is sponsoring clinical trial NCT01269801?

This trial is sponsored by AboutSkin Dermatology and DermSurgery, PC, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01269801 being conducted?

This trial has 3 study locations across Colorado, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01269801, the US trial registry maintained by the National Library of Medicine. NCT01269801 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.