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

NCT ID: NCT02626598

Last Updated: 2015-12-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-07-31

Brief 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

Keywords

facial wrinkles; photoaging

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Blended Belotero

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Treated patients

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merz Aesthetics Inc.

INDUSTRY

Sponsor Role: collaborator

Skin Care and Laser Physicians of Beverly Hills

OTHER

Sponsor Role: lead

Responsible Party

Derek H. Jones, M.D.

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derek H Jones, MD

Role: PRINCIPAL_INVESTIGATOR

Skin Care and Laser Physicians of Beverly Hills

Locations

Skin Care and Laser Physicians of Beverly Hills

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19021673 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11711957 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25908703 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22316189 (View on PubMed)

Other Identifiers

IIS2202

Identifier Type: -

Identifier Source: org_study_id