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Upper Facial Remodeling With Perlane-L and Dysport

NCT01354743 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-09-26

No results posted yet for this study

Summary

The purpose of this study is to provide data to support combination treatment of the upper face with Perlane-L® and Dysport™. This study will assess the outcome of upper face rejuvenation in the temporal fossa; outcome of glabella and/or periorbital regions will also be assessed as a secondary endpoint.

Conditions

  • Mild to Moderate Temporal Atrophy
  • Moderate to Severe Glabellar Rhytids
  • Moderate to Severe Periorbital Rhytids

Interventions

DRUG

Dysport

Patients entering will be based on gender and assessment of procerus and corrugator muscle mass. Muscle mass will be graded separately for males and females as +, ++, or+++ (light/small, moderate/medium, or heavy/large) by assessment of the procerus/corrugator muscles. Male patients will receive 0.3 mL to 0.4 mL (60, 70, or 80 units) in five equally divided doses of Dysport™ Female patients will receive 0.25 mL to 0.35 mL (50, 60 or 70 units) in equally divided doses of Dysport™ at 5 designated injection sites in the glabellar region Subjects will be treated with Dysport™ 20 or 30 units bilaterally to crow's feet. Subjects will be treated at baseline and if maximum amount of product has not been used at 1 month follow up subject will receive a touch up. No further treatment will be done for the remaining study visits.

DEVICE

Perlane L

The subject will be allowed to receive up to 4 mls between the temporal fossa and the glabella area.

Sponsors & Collaborators

  • Medicis Pharmaceutical Corporation

    collaborator INDUSTRY

  • Beer, Kenneth R., M.D., PA

    lead INDIV

Principal Investigators

  • Kenneth Beer M.D. · Kenneth Beer, M.D., PA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-12-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01354743 on ClinicalTrials.gov