A Study Evaluating Blended Belotero for the Treatment of Etched-in Fine Facial Lines
Status unconfirmed
Conditions studied: Rhytidosis Facialis
In brief
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.
Key facts
- Study ID
- NCT02626598
- Run by
- Skin Care and Laser Physicians of Beverly Hills
- People needed
- 30
- Starts
- 2015-12-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2015-12-10
Who can join
Age: 25 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult females and males, aged 25-75 years.
- Subjects must be seeking treatment for etched-in fine lines of the cutaneous lip area, and/or radial cheek area, and/or nasolabial fold area, and/or melolabial fold area, and/or forehead area.
- Subjects must have one or more etched-in fine line on the cutaneous lip area, and/or radial cheek area, and/or nasolabial fold area, and/or melolabial fold area, and/or forehead area.
- Subjects must have been deemed eligible by the treating physician and be scheduled for treatment of etched-in fine facial lines with Belotero blended with lidocaine with epinephrine.
- Subjects must be willing to defer any other cosmetic procedures in the treatment area while in the study. They can continue using topicals with retinoids, retinol, beta hydroxy acids, or alpha hydroxyl acids if they were previously using these topicals for at least 3 months prior to starting the study, but they should not initiate cosmetic treatments with new topicals during the study period. They should not have cosmetic treatments such as chemical peels, microdermabrasion, microneedling procedures, laser procedures, botulinum toxin injections, or other injectable filler therapy in the treatment area during the study period.
- Subjects must be willing and able to provide written informed consent in English
- Subjects must be willing and able to follow the procedures outlined in this protocol.
You may not qualify if…
- Subjects who are pregnant.
- Subjects with previous permanent injectable filler therapy to the treatment area.
- Subjects with previous non-permanent injectable filler therapy to the treatment area within the past year.
- Subjects with previous botulinum toxin injections in the treatment area within the past 6 months.
- Subjects with severe baseline facial lines in the treatment area with a score of 5 based on the Validated Lemperle Facial Wrinkle Scales.
- Subjects with visible scars in the treatment area that may affect evaluation of response and/or quality of photography in the opinion of the investigator.
- Known allergy or sensitivity to any of the treatment injections or their components, including or known or suspected lidocaine hypersensitivity.
- Subjects with an infection in the treatment area.
- Subjects are not to undergo any additional cosmetic procedures in the treatment area during the study period.
- Subjects with a history of poor cooperation, non-compliance with medical treatment, or unrealiability.
Where it is running
- Skin Care and Laser Physicians of Beverly Hills — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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