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OpenTrials
Completed

NCT Number: NCT00407914

Safety and Effectiveness of Aquamid as Compared to Restylane for the Aesthetic Treatment of Nasolabial Folds

The purpose of this study is to compare the effectiveness of Aquamid and Restylane in aesthetically enhancing nasolabial folds 6 months after treatment and to evaluate the safety of Aquamid through 12 months after treatment.

The study includes an extended follow up to 24 months.

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Key information

Conditions

Facial Wrinkles

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

White Plains, New York, 10604, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • interested on soft tissue augmentation for the nasolabial folds
  • moderate to severe nasolabial fold

Exclusion criteria

  • sensitivity to anesthetics
  • allergy to hyaluronic acid
  • previous treatment with permanent fillers in the treated area
  • recent previous aesthetic procedure in the treatment area
  • infected skin areas or autoimmune diseases affecting the skin

Treatment and study plan

Aquamid

Device

Subcutaneous injection

Restylane

Device

Injection in dermis

Primary outcomes

  1. Wrinkle Assessment Scale

    Time frame: Baseline, 3, 6, 9, 12 Months

  2. Adverse device effects

    Time frame: continuosly

Secondary outcomes

  1. Global Aesthetic Improvement Scale

    Time frame: Optimal treatment, 3, 6, 9 and 12 Months

  2. Injection site reactions

    Time frame: After injection

  3. Adverse events

    Time frame: continuosly

Sponsors and collaborators

Lead sponsor

Contura

Industry

Registry information

Official study title

A Double-Masked, Randomized, Multi-Center, 2-Arm Parallel Study Comparing the Safety and Effectiveness of Aquamid and Restylane for the Aesthetic Treatment of Nasolabial Folds

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Dec 5, 2006
Registry last updated
Oct 8, 2009

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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