Face Clinical Trial
Official title:
Efficacy of Prabotulinum Toxin-A and Onabotulinum Toxin-A for the Treatment of Expression Lines in the Upper Third of the Face.
Verified date | April 2023 |
Source | Instituto de Oftalmología Fundación Conde de Valenciana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The appearance of facial wrinkles, lines, or folds is a natural phenomenon during aging. Different scales help classify wrinkles objectively, such as the Facial Wrinkle Scale. Others help classify patients' subjective perspectives, like the Face-Q questionnaire. The application of Botulinum Toxin is the most performed non-surgical aesthetic procedure in the world to treat facial expression lines. The present study aims to compare the efficacy of onabotulinum toxin-A (BOTOX®) and prabotulinum toxin-A (NABOTA®) to treat expression lines in the upper third of the face, based on objective and subjective follow-up, using the FWS scale and FACE-Q questionnaire, respectively.
Status | Completed |
Enrollment | 26 |
Est. completion date | January 15, 2021 |
Est. primary completion date | January 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 40 Years |
Eligibility | Inclusion Criteria: - 25 and 40 years of age - Diagnosis of expression lines in the upper facial third of any degree - Wished to improve their aesthetic appearance Exclusion Criteria: - Known allergy to milk protein or albumin - Pregnancy and lactation - Cardiovascular or neuromuscular disease - Recent history of infections in the facial region - Concomitant intake of aminoglycosides or cyclosporine A |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto de Oftalmología | Mexico City | |
Mexico | Institute of Ophthalmology, Conde de Valenciana Foundation | Mexico, City | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto de Oftalmología Fundación Conde de Valenciana |
Mexico,
Cheon HI, Jung N, Won CH, Kim BJ, Lee YW. Efficacy and Safety of Prabotulinumtoxin A and Onabotulinumtoxin A for Crow's Feet: A Phase 3, Multicenter, Randomized, Double-Blind, Split-Face Study. Dermatol Surg. 2019 Dec;45(12):1610-1619. doi: 10.1097/DSS.00 — View Citation
Conkling N, Bishawi M, Phillips BT, Bui DT, Khan SU, Dagum AB. Subjective rating of cosmetic treatment with botulinum toxin type A: do existing measures demonstrate interobserver validity? Ann Plast Surg. 2012 Oct;69(4):350-5. doi: 10.1097/SAP.0b013e31824a43e0. — View Citation
Hadi H, Wilkinson CM. Categorizing facial creases: A review. J Cosmet Dermatol. 2017 Jun;16(2):180-185. doi: 10.1111/jocd.12305. Epub 2017 Feb 1. — View Citation
Huang W, Foster JA, Rogachefsky AS. Pharmacology of botulinum toxin. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):249-59. doi: 10.1067/mjd.2000.105567. — View Citation
Klein AW. Contraindications and complications with the use of botulinum toxin. Clin Dermatol. 2004 Jan-Feb;22(1):66-75. doi: 10.1016/j.clindermatol.2003.12.026. — View Citation
Kohl E, Steinbauer J, Landthaler M, Szeimies RM. Skin ageing. J Eur Acad Dermatol Venereol. 2011 Aug;25(8):873-84. doi: 10.1111/j.1468-3083.2010.03963.x. Epub 2011 Jan 24. — View Citation
Nam HS, Park YG, Paik NJ, Oh BM, Chun MH, Yang HE, Kim DH, Yi Y, Seo HG, Kim KD, Chang MC, Ryu JH, Lee SU. Efficacy and safety of NABOTA in post-stroke upper limb spasticity: a phase 3 multicenter, double-blinded, randomized controlled trial. J Neurol Sci — View Citation
Satriyasa BK. Botulinum toxin (Botox) A for reducing the appearance of facial wrinkles: a literature review of clinical use and pharmacological aspect. Clin Cosmet Investig Dermatol. 2019 Apr 10;12:223-228. doi: 10.2147/CCID.S202919. eCollection 2019. — View Citation
Sundaram H, Signorini M, Liew S, Trindade de Almeida AR, Wu Y, Vieira Braz A, Fagien S, Goodman GJ, Monheit G, Raspaldo H; Global Aesthetics Consensus Group. Global Aesthetics Consensus: Botulinum Toxin Type A--Evidence-Based Review, Emerging Concepts, and Consensus Recommendations for Aesthetic Use, Including Updates on Complications. Plast Reconstr Surg. 2016 Mar;137(3):518e-529e. doi: 10.1097/01.prs.0000475758.63709.23. — View Citation
Won CH, Kim HK, Kim BJ, Kang H, Hong JP, Lee SY, Kim CS. Comparative trial of a novel botulinum neurotoxin type A versus onabotulinumtoxinA in the treatment of glabellar lines: a multicenter, randomized, double-blind, active-controlled study. Int J Dermat — View Citation
Yaar M, Gilchrest BA. Photoageing: mechanism, prevention and therapy. Br J Dermatol. 2007 Nov;157(5):874-87. doi: 10.1111/j.1365-2133.2007.08108.x. Epub 2007 Aug 17. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in subjective evaluation of botulinum toxin between groups | Evaluation using Face-Q questionnaire on each visit, answered by the patient. Questionnaire-based Likert scale with a min value of 1 and maximum value of 4, qualifying patient's satisfaction with their facial appearance. | Pre treatment | |
Primary | Change in subjective evaluation of botulinum toxin between groups | Evaluation using Face-Q questionnaire on each visit, answered by the patient. Questionnaire-based Likert scale with a min value of 1 and maximum value of 4, qualifying patient's satisfaction with their facial appearance. | On day 7 | |
Primary | Change in subjective evaluation of botulinum toxin between groups | Evaluation using Face-Q questionnaire on each visit, answered by the patient. Questionnaire-based Likert scale with a min value of 1 and maximum value of 4, qualifying patient's satisfaction with their facial appearance. | On day 30 | |
Primary | Change in subjective evaluation of botulinum toxin between groups | Evaluation using Face-Q questionnaire on each visit, answered by the patient. Questionnaire-based Likert scale with a min value of 1 and maximum value of 4, qualifying patient's satisfaction with their facial appearance. | On day 120 | |
Primary | Change in objective evaluation of botulinum toxin between groups | Evaluation using Facial Wrinkle Scale on each visit, made by the main author. It is an objective scale with four points, minimum score 0, none; 1, mild; 2, moderate; and maximum score 3, severe. | Pretreatment | |
Primary | Change in objective evaluation of botulinum toxin between groups | Evaluation using Facial Wrinkle Scale on each visit, made by the main author. It is an objective scale with four points, minimum score 0, none; 1, mild; 2, moderate; and maximum score 3, severe. | On day 7 | |
Primary | Change in objective evaluation of botulinum toxin between groups | Evaluation using Facial Wrinkle Scale on each visit, made by the main author. It is an objective scale with four points, minimum score 0, none; 1, mild; 2, moderate; and maximum score 3, severe. | On day 30 | |
Primary | Change in objective evaluation of botulinum toxin between groups | Evaluation using Facial Wrinkle Scale on each visit, made by the main author. It is an objective scale with four points, minimum score 0, none; 1, mild; 2, moderate; and maximum score 3, severe. | On day 120 | |
Secondary | Duration of activity | Time of efficacy for muscle blockage on maximun expression | On day 30 | |
Secondary | Duration of activity | Time of efficacy for muscle blockage on maximun expression | On day 120 | |
Secondary | Onset of action | Time required from application to muscle blockage on maximum expression | On day 7 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05177380 -
Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis
|
N/A | |
Active, not recruiting |
NCT05400551 -
Craneofacial Injuries in Rink Hockey Athletes
|
||
Completed |
NCT04970290 -
Clinical and Instrumental Evaluation on Definisse Threads
|
N/A | |
Recruiting |
NCT03926403 -
Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia
|
N/A | |
Completed |
NCT04980586 -
Cheeks Appearance as a Novel Predictor of Obstructive Sleep Apnea The CASA Score Study
|
||
Not yet recruiting |
NCT04745247 -
Stimulate the Face to Improve Tactile Acuity on the Hand
|
N/A | |
Completed |
NCT03369028 -
Fitting of Commonly Available Face Masks for Late Preterm and Term Infants
|