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Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds

NCT00414544 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2011-06-27

Study results available
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Summary

This is a randomized, double-blind pivotal study to evaluate the safety and effectiveness of CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as nasolabial folds (i.e., smile lines).

Conditions

  • Facial Wrinkles

Interventions

DEVICE

CosmetaLife

Dermal filler

DEVICE

Restylane

Dermal filler

Sponsors & Collaborators

  • Cosmeta Corp, A Gel-Del Technologies Company

    collaborator UNKNOWN

  • Cosmeta

    lead INDUSTRY

Principal Investigators

  • David B. Masters, Ph.D. · Cosmeta™ Corp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-09-30
Completion
2008-03-31

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 NCT00414544 on ClinicalTrials.gov