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OpenTrials
Completed

NCT Number: NCT00977704

Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles

This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.

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Key information

Conditions

Peri-oral Wrinkles

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Call For Information, Coral Gables, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Same Wrinkle Severity (either both Moderate [3] or both Severe [4]) of marionette lines and upper peri-oral rhytids

Exclusion criteria

  • Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds
  • Subjects who had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months prior to study entry
  • Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
  • Permanent implant placed in the Nasolabial Fold area

Treatment and study plan

Restylane and Perlane

Device

Primary outcomes

  1. Local and Systemic Adverse Events

    Time frame: 2-weeks

    To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of:

    • All local adverse events as reported by healthcare professional
    • All systemic adverse events (related and unrelated)

Sponsors and collaborators

Lead sponsor

Medicis Global Service Corporation

Industry

Registry information

Official study title

An Open-label Study of the Safety of Restylane and Perlane in the Correction of Peri-oral Wrinkles.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 16, 2009
Registry last updated
Jun 10, 2013

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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