NCT02626598

A Study Evaluating Blended Belotero for the Treatment of Etched-in Fine Facial Lines

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Skin Care and Laser Physicians of Beverly Hills · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a single center study for adult females or males ages 25 to 75 years who are seeking treatment for etched-in fine lines of the cutaneous lip, and/or radial cheek area, and/or nasolabial folds, and/or melolabial folds, and/or forehead. The purpose of this study is to evaluate blended Belotero for the treatment of etched-in fine facial lines and to monitor for adverse events.

Detailed description

This is a study to evaluate the effects of Belotero blended with 0.1 cc of 1% lidocaine with epinephrine per 1.0 cc of Belotero in the treatment of etched-in fine facial lines. 30 adults scheduled to have blended Belotero injected into fine lines of the cutaneous lip, and/or radial cheek area, and/or nasolabial folds, and/or melolabial folds, and/or forehead will be evaluated. The blended Belotero will be injected intradermally into these etched-in fine lines. The patients will be given diary cards to document potential adverse events. 2 weeks after receiving injections of the blended Belotero the subjects will return to have photographs taken, have their treated fine lines evaluated, and complete a self assessment questionnaire. Touch-up injections are common clinical practice and if additional touch-ups would improve their result, those subjects can be re-treated at this visit. Those subjects who are touched up will return to the clinic for an additional follow up visit and photographs 2 weeks later. All subjects will return to the clinic 12 weeks and 24 weeks after their last injection for photographs and evaluations. Improvement assessments will be made by investigator ratings at each visit. Investigator ratings for the cutaneous lip and the forehead area are based on the Merz Aesthetic Validated Assessment Scales. Investigator ratings for the radial cheek area, nasolabial folds, and melolabial folds are based on the Validated Lemperle Facial Wrinkle Scales.

Conditions

• Rhytidosis Facialis

Interventions

Type	Name	Description
DEVICE	Blended Belotero	Belotero blended with 0.1 cc of 1% lidocaine with epinephrine per 1.0 cc Belotero will be injected to etched in fine facial lines

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-12-10
• Last updated: 2015-12-10

Locations

1 site across 1 country: United States