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| Name | Class |
|---|---|
| Merz Aesthetics Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated patients | Patients treated with blended Belotero 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 area will be evaluated with photographs, physician ratings, and patient improvement assessments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blended Belotero | Device | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Subject Improvement Evaluations of Treated Facial Lines |
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Inclusion Criteria:
Exclusion Criteria:
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This is a single-center observational study of adult females and males ages 25 to 75 years who are scheduled to have treatment with Belotero blended with lidocaine with epinephrine, as is common in clinical practice 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 area. After reviewing the risks and benefits of the procedure, the patient will sign a clinical consent form prior to treatment. If the patient is amenable to participate in the study and agrees to have pre and post treatment photographs and evaluations completed, they will proceed to sign the research consent form and will be enrolled into the study.
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| Name | Affiliation | Role |
|---|---|---|
| Derek H Jones, MD | Skin Care and Laser Physicians of Beverly Hills | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Care and Laser Physicians of Beverly Hills | Los Angeles | California | 90069 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19021673 | Background | 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. | |
| 11711957 |
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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 |
| 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. doi: 10.1097/00006534-200111000-00048. |
| 25908703 | Background | 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. |
| 22316189 | Background | Narins RS, Carruthers J, Flynn TC, Geister TL, Gortelmeyer 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. |