Rhytidosis Facialis Clinical Trial
Official title:
A Study Evaluating Blended Belotero for the Treatment of Etched-in Fine Facial Lines
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.
| Status | Enrolling by invitation |
| Enrollment | 30 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 25 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Skin Care and Laser Physicians of Beverly Hills | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| Skin Care and Laser Physicians of Beverly Hills | Merz Aesthetics Inc. |
United States,
Carruthers A, Carruthers J, Hardas B, Kaur M, Goertelmeyer R, Jones D, Rzany B, Cohen J, Kerscher M, Flynn TC, Maas C, Sattler G, Gebauer A, Pooth R, McClure K, Simone-Korbel U, Buchner L. A validated grading scale for forehead lines. Dermatol Surg. 2008 Nov;34 Suppl 2:S155-60. doi: 10.1111/j.1524-4725.2008.34364.x. — View Citation
Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. — View Citation
Moradi A, Shirazi A, Moradi-Poehler J, Turner J, Howell DJ. A blinded, randomized, split-face pilot study of bruising and pain with hyaluronic acid for correction of perioral lines using no lidocaine, lidocaine alone, and lidocaine and epinephrine. Aesthet Surg J. 2015 May;35(4):443-55. doi: 10.1093/asj/sjv043. — View Citation
Narins RS, Carruthers J, Flynn TC, Geister TL, Görtelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, de Maio M, Mohrmann C, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Breitscheidel L, Carruthers A. Validated assessment scales for the lower face. Dermatol Surg. 2012 Feb;38(2 Spec No.):333-42. doi: 10.1111/j.1524-4725.2011.02247.x. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Investigator Fine Facial Line Evaluations (Merz Aesthetic Validated Assessment Scales for cutaneous lip and the forehead and Validated Lemperle Facial Wrinkle Scales for the radial cheek, nasolabial folds, and melolabial folds) | Investigator evaluations and ratings of fine facial lines will be made 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. | 24-26 weeks | No |
| Secondary | Patient Diary Cards Documenting Adverse Events | Patients will be given diary cards to document any potential adverse events for 2 weeks after each treatment. | 2-4 weeks | No |
| Secondary | Subject Improvement Evaluations of Treated Facial Lines | Subject improvement evaluations will be made at each visit with exception to the first visit. Subjects will rate the percent improvement of the treated facial lines (0-25% Improvement, 25-49% Improvement, 50-74% Improvement, or 75-100% Improvement). | 24-26 weeks | No |