Botulinum Toxin, Rejuvenation, Neck, Therapy Clinical Trial
Official title:
Nefertiti Lift for Neck Rejuvenation: Assessing Efficiency and Re-defining Patient Selection
The purpose of this study is to describe a safe and consistent technique for neck rejuvenation using botulinum toxin. This study will also evaluate the efficiency of the intervention and determine the patients that would benefit most.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | October 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: Female patients presenting to our clinic for neck rejuvenation who: - Were deemed nonsurgical candidates for neck rejuvenation - Were not willing to undergo invasive surgical procedures - Had a medical contraindication to surgery Exclusion Criteria: - Patients with lower face botulinum toxin injection in the past 12 months - Patients with resorbable lower face fillers injection in the past 12 months - Patients with previous permanent lower face fillers injection - Pregnant patients - Lactating patients - Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome) - Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics) - Patients with sensitivity to botulinum toxin or human albumin |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Lebanon | Hotel Dieu De France | Beirut | Aschrafieh |
| Lead Sponsor | Collaborator |
|---|---|
| St Joseph University, Beirut, Lebanon |
Lebanon,
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 marionette lines. Dermatol Surg. 2008 Nov;34 Suppl 2:S167-72. doi: 10.1111/j.1524-4725.2008.34366.x. — View Citation
Geister TL, Bleßmann-Gurk B, Rzany B, Harrington L, Görtelmeyer R, Pooth R. Validated assessment scale for platysmal bands. Dermatol Surg. 2013 Aug;39(8):1217-25. doi: 10.1111/dsu.12240. Epub 2013 May 7. — View Citation
Gupta S, Biskup N, Mattison G, Leis A. Development and Validation of a Clinical Assessment Tool for Platysmal Banding in Cervicomental Aesthetics of the Female Neck. Aesthet Surg J. 2015 Aug;35(6):NP141-6. doi: 10.1093/asj/sju160. — 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
Sattler G, Carruthers A, Carruthers J, Flynn TC, Geister TL, Görtelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, Mohrmann C, Narins RS, Pooth R, Rzany B, Buchner L, Benter U, Breitscheidel L, de Maio M. Validated assessment scale for neck volume. Dermatol Surg. 2012 Feb;38(2 Spec No.):343-50. doi: 10.1111/j.1524-4725.2011.02253.x. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Neck volume using a validated scale from the Summit Scale II (1) | The assessment will be done by 2 plastic surgeons and 1 dermatologist. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale . The 3 evaluators will be blinded to the pre or post injection status of the photos No Sagging Mild Sagging Moderate Sagging Severe Sagging Very Severe Sagging |
15-25 days post treatment | No |
| Primary | Jowls at rest using a validated scale from the Summit Scale II (2) | The assessment will be done by 2 plastic surgeons and 1 dermatologist. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale . The 3 evaluators will be blinded to the pre or post injection status of the photos No Sagging Mild Sagging Moderate Sagging Severe Sagging Very Severe Sagging |
15-25 days post treatment | No |
| Primary | Marionette lines at rest using a validated scale from the Summit Scale II (3) | The assessment will be done by 2 plastic surgeons and 1 dermatologist. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale . The 3 evaluators will be blinded to the pre or post injection status of the photos No visible folds: continuous skin lines Shallow but visible folds with slight indentation Moderately deep folds, clear feature at normal appearance, but not when stretched Very long and deep folds, prominent facial feature Extremely long and deep folds; detrimental facial appearance |
15-25 days post treatment | No |
| Primary | Oral commissures at rest using a validated scale from the Summit Scale II (2) | The assessment will be done by 2 plastic surgeons and 1 dermatologist. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale . The 3 evaluators will be blinded to the pre or post injection status of the photos No Downturn Mild Downturn Moderate Downturn Severe Downturn Very Severe Downturn |
15-25 days post treatment | No |
| Primary | Platysmal bands at maximal contraction using a validated scale (4) | The assessment will be done by 2 plastic surgeons and 1 dermatologist. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale . The 3 evaluators will be blinded to the pre or post injection status of the photos No relevant prominence of platysmal bands Mild prominence of platysmal bands Moderate prominence of platysmal bands Severe prominence of platysmal bands Very severe prominence of platysmal bands |
15-25 days post treatment | No |
| Primary | Platysmal bands at rest using a validated scale (5) | The assessment will be done by 2 plastic surgeons and 1 dermatologist. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale . The 3 evaluators will be blinded to the pre or post injection status of the photos No platsymal bands visible at rest Mild platysmal bands evident at rest. Bands do not appear along the full length of the neck. Mild platysmal bands evident along the full length of the neck at rest, less than 5 mm of elevation from the surrounding tissue. Moderate platsymal bandsvisible at rest along the full length of the neck, elevation at least 5 mm from the surrounding tissue. Severe platsymal bands along the full length of the neck at rest, elevation at least 5 mm from the surrounding tissue, with additional soft tissue ptotic banding present laterally |
15-25 days post treatment | No |
| Primary | Mandibular definition change with maximal contraction will be assessed by a 2-point scale | The assessment of the pre-injection photos will be done by 2 plastic surgeons and 1 dermatologist Mandibular contour does not worsen with platysmal contraction Mandibular contour worsen with platysmal contraction |
15-25 days post treatment | No |
| Secondary | Investigators Global Aesthetic Improvement Scale | Improvement in Overall appearance (global neck, jowls, skin laxity, platysmal bands, mandibular contour), as assessed by the investigators using the Global Aesthetic Improvement Scale (GAIS). GAIS will be completed based on photographic assessment comparing post-treatment photos taken at day 15-25 post intervention to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) as follows: Very Much Improved: optimal cosmetic results Much Improved: marked improvement in appearance from initial condition but not completely optimal Improved: obvious improvement in appearance from initial condition but additional treatments are advised No Change: the appearance is the same as the original condition Worse: the appearance is worse from the original condition |
15-25 days post treatment | No |
| Secondary | Subject Global Aesthetic Improvement Scale | Improvement in Overall appearance (global neck, jowls, skin laxity, platysmal bands, mandibular contour), as assessed by the subject using the Global Aesthetic Improvement Scale (GAIS). GAIS will be completed based on a live assessment of the subject with a mirror in hand for real time assessment and and a photographic assessment comparing post-treatment photos taken at day 15-25 post intervention to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) as follows: Very Much Improved: optimal cosmetic results Much Improved: marked improvement in appearance from initial condition but not completely optimal Improved: obvious improvement in appearance from initial condition but additional treatments are advised No Change: the appearance is the same as the original condition Worse: the appearance is worse from the original condition |
15-25 days post treatment | No |
| Secondary | Patient satisfaction | Patient satisfaction will be determined by a questionnaire completed at 15-25 days post-treatment. Subjects will indicate how satisfied they are on a 4-point scale (1-4) as follow: Very Satisfied Satisfied Dissatisfied Very Dissatisfied. |
15-25 days post treatment | No |
| Secondary | Patient willingness to repeat the procedure | Patient willingness to repeat the procedure will be assessed by a simple question with a Yes or No response | 15-25 days post treatment | No |
| Secondary | Patient willingness to recommend the procedure | Patient willingness to recommend the procedure to a friend will be assessed by a simple question with a Yes or No response | 15-25 days post treatment | No |
| Secondary | Assessment of Pain during treatment | Subjects' pain during the treatment will be recorded using a validated Numeric Rating Scale (0-10), with 0 representing no pain and 10 representing the worst pain possible | At the day of the procedure | No |