NCT00922623

Safety and Effectiveness of Belotero® in Subjects With Fitzpatrick Phototypes IV Through VI

A Multicenter Study of The Safety and Effectiveness of Dermal Filler, Belotero®, After Mid-to-Deep Dermal Implantation for Correction of Moderate to Severe Facial Wrinkles (Such as Nasolabial Folds) Over 24 Weeks in Subjects With Fitzpatrick Phototype Scores of IV, V, and VI.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a study to assess how safe and effective an investigational product, Belotero® is in people with all skin types with facial wrinkles, such as nasolabial folds. Nasolabial folds are wrinkles on the face that go from outside of the nostrils to the edges of the mouth.

Detailed description

The Fitzpatrick Skin Phototype Scale goes from number 1 (I), which is the very lightest skin tone, to number 6 (VI) which is the very darkest skin tone. This study is to determine the safety and effectiveness of Belotero® in people with skin phototypes of 1(I)thru 6 (VI).

Conditions

• Facial Wrinkles

Interventions

Type	Name	Description
DEVICE	Belotero®	Hyaluronic acid dermal filler, Belotero®, single use syringe, injected into mid to deep dermal layer

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-06-17
• Last updated: 2013-04-26
• Results posted: 2012-01-30

Locations

3 sites across 1 country: United States