Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
NCT ID: NCT03799484
Last Updated: 2020-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
14 participants
INTERVENTIONAL
2019-01-04
2019-06-14
Brief Summary
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Detailed Description
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The objective of this study is to determine whether there is a difference in clinical effect (weakness/paralysis of the frontalis muscle), duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia (2.5% lidocaine/2.5 % prilocaine cream, Impax Laboratories, LLC) on one side of the forehead and petrolatum ointment on the other prior to BTX-A administration for the treatment of forehead rhytides.
* Primary outcome variable is change of eyebrow excursion on each side of the forehead from baseline to each follow-up visit.
* Secondary outcome variables
* Duration of effect, defined as the elapsed time from injection to the end of botulinum, such that return of baseline frontalis function, i.e. within 2 mm of baseline value
* Perception of pain immediately after injection at each side
* Patient satisfaction for each side
* Patient's perception of difference in efficacy
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Topical Anesthesia
2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection
Botulinum toxin type A
Botulinum toxin type A will be administered to both sides
2.5% lidocaine/2.5% prilocaine
2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead
Petrolatum
Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection
Botulinum toxin type A
Botulinum toxin type A will be administered to both sides
petrolatum ointment
petrolatum ointment will be applied to one side of the forehead
Interventions
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Botulinum toxin type A
Botulinum toxin type A will be administered to both sides
2.5% lidocaine/2.5% prilocaine
2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead
petrolatum ointment
petrolatum ointment will be applied to one side of the forehead
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of horizontal forehead rhytides
* Good eyebrow excursion (greater than or equal to 5 mm)
* Able to understand and sign an informed consent form that has been approved by the Committee for the Protection of Human Subjects
Exclusion Criteria
* Known allergy to botulinum toxin
* Known history of sensitivity to local anesthetics of the amide type
* Existing disorder of neuromuscular transmission
* Usage of medication with effect on neuromuscular function
* Women of childbearing potential (who are not postmenopausal for at least 1 year or surgically sterile), who are pregnant or nursing or intend to become pregnant during the time of the study
* Significant brow asymmetry (\> 5mm)
* Unable to follow-up for the duration of the study (16 weeks)
18 Years
65 Years
ALL
Yes
Sponsors
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Robert Cizik Eye Clinic
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Karina Richani-Reverol
Clinical Assistant Professor
Principal Investigators
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Karina Richani-Reverol, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Robert Cizik Eye Clinic
Houston, Texas, United States
Countries
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References
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Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. J Pediatr Ophthalmol Strabismus. 1980 Jan-Feb;17(1):21-5. doi: 10.3928/0191-3913-19800101-06.
Carruthers A, Carruthers J. Clinical indications and injection technique for the cosmetic use of botulinum A exotoxin. Dermatol Surg. 1998 Nov;24(11):1189-94. doi: 10.1111/j.1524-4725.1998.tb04097.x.
Carter SR, Seiff SR. Cosmetic botulinum toxin injections. Int Ophthalmol Clin. 1997 Summer;37(3):69-79. doi: 10.1097/00004397-199703730-00006. No abstract available.
Charles PD. Botulinum neurotoxin serotype A: a clinical update on non-cosmetic uses. Am J Health Syst Pharm. 2004 Nov 15;61(22 Suppl 6):S11-23. doi: 10.1093/ajhp/61.suppl_6.S11.
Carruthers A, Carruthers J. Aesthetic indications for botulinum toxin injections. Plast Reconstr Surg. 1995 Feb;95(2):427-8. doi: 10.1097/00006534-199502000-00049. No abstract available.
Clark RP, Berris CE. Botulinum toxin: a treatment for facial asymmetry caused by facial nerve paralysis. Plast Reconstr Surg. 1989 Aug;84(2):353-5.
Sami MS, Soparkar CN, Patrinely JR, Hollier LM, Hollier LH. Efficacy of botulinum toxin type a after topical anesthesia. Ophthalmic Plast Reconstr Surg. 2006 Nov-Dec;22(6):448-52. doi: 10.1097/01.iop.0000248989.33572.3c.
Gordin EA, Luginbuhl AL, Ortlip T, Heffelfinger RN, Krein H. Subcutaneous vs intramuscular botulinum toxin: split-face randomized study. JAMA Facial Plast Surg. 2014 May-Jun;16(3):193-8. doi: 10.1001/jamafacial.2013.2458.
Li Y, Dong W, Wang M, Xu N. Investigation of the Efficacy and Safety of Topical Vibration Anesthesia to Reduce Pain From Cosmetic Botulinum Toxin A Injections in Chinese Patients: A Multicenter, Randomized, Self-Controlled Study. Dermatol Surg. 2017 Dec;43 Suppl 3:S329-S335. doi: 10.1097/DSS.0000000000001349.
Shi LL, Sargen MR, Chen SC, Arbiser JL, Pollack BP. Effective local anesthesia for onabotulinumtoxin A injections to treat hyperhidrosis associated with traumatic amputation. Dermatol Online J. 2016 Jun 15;22(6):13030/qt38b203d0.
Baumann LS, Grunebaum L, Elsaie ML, Murdock J, Jablonka E, Figueras K, Bell M. Safety and efficacy of a rapid-acting topical 4% lidocaine gel in a unique drug delivery system. J Drugs Dermatol. 2010 Dec;9(12):1500-4.
Weiss RA, Lavin PT. Reduction of pain and anxiety prior to botulinum toxin injections with a new topical anesthetic method. Ophthalmic Plast Reconstr Surg. 2009 May-Jun;25(3):173-7. doi: 10.1097/IOP.0b013e3181a145ca.
Alam M, Bolotin D, Carruthers J, Hexsel D, Lawrence N, Minkis K, Ross EV. Consensus statement regarding storage and reuse of previously reconstituted neuromodulators. Dermatol Surg. 2015 Mar;41(3):321-6. doi: 10.1097/DSS.0000000000000303.
Carruthers J, Fagien S, Matarasso SL; Botox Consensus Group. Consensus recommendations on the use of botulinum toxin type a in facial aesthetics. Plast Reconstr Surg. 2004 Nov;114(6 Suppl):1S-22S. doi: 10.1097/01.PRS.0000144795.76040.D3.
Ito H, Ito H, Nakano S, Kusaka H. Low-dose subcutaneous injection of botulinum toxin type A for facial synkinesis and hyperlacrimation. Acta Neurol Scand. 2007 Apr;115(4):271-4. doi: 10.1111/j.1600-0404.2006.00746.x.
Tzou CH, Giovanoli P, Ploner M, Frey M. Are there ethnic differences of facial movements between Europeans and Asians? Br J Plast Surg. 2005 Mar;58(2):183-95. doi: 10.1016/j.bjps.2004.10.014.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-18-0908
Identifier Type: -
Identifier Source: org_study_id
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