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NCT Number: NCT00414544

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

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).

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Key information

Conditions

Facial Wrinkles

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beauty Renewed, Tracy, California, United States

Loading trial locations.

About this study

Patients with negative reaction skin test results will be randomized to receive CosmetaLife in one nasolabial fold and Control in the nasolabial fold on the opposite side of the face (split face design). Each subject will serve as his or her own control, allowing for comparison of the outcome between the contralateral sides. Patients will be followed at 2 weeks and 3, 6, 9 and 12 months post treatment for assessment of safety and effectiveness.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years of age or older
  • Patients with moderate nasolabial folds (3-4 WSRS scale)
  • Patients willing to provide written informed consent for their participation in the study
  • Patients willing to abstain from other facial cosmetic procedures through the 12 month follow-up visit

Exclusion criteria

  • Patients with any aesthetic facial therapy within 6 months prior to
  • Patients with an any reaction to the skin test
  • Patients with a history of autoimmune disorder, lidocaine reactions, allergy to heparin, other severe or chronic allergies
  • Patients with a current disease state that can effect the immunoresponse, or patients on immunosuppressive therapy
  • Patients with an active infection of any kind, skin disease, connective tissue disorder
  • Patients who are pregnant or lactating
  • Patients enrolled in another investigational clinical trial

Treatment and study plan

CosmetaLife

Device

Dermal filler

Restylane

Device

Dermal filler

Primary outcomes

  1. Change in Wrinkle Severity Rating Scale

    Time frame: baseline and 6 months

    To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded.

  2. Adverse Event Reporting

    Time frame: 6 months

Secondary outcomes

  1. Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months

    Time frame: 3, 9 and 12 months

Sponsors and collaborators

Lead sponsor

Cosmeta

Industry

Collaborators

  • Cosmeta Corp, A Gel-Del Technologies Company

Registry information

Official study title

A Randomized, Double-Blind, Multicenter Comparison of the Safety and Efficacy of CosmetaLife™ Versus Control for the Correction of Nasolabial Folds

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Dec 21, 2006
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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