Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

NCT03799484 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-18-0908
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether there is a difference in clinical effect, duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to Botulinum Toxin Type A administration for the treatment of forehead rhytides.

Conditions

Forehead Rhytides; Forehead Wrinkles

Keywords

Rhytides; Forehead Wrinkles

Outcome Measures

Primary Outcomes (4)

• Eyebrow Excursion

  Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.

  Baseline

• Eyebrow Excursion

  Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.

  Week 2

• Eyebrow Excursion

  Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.

  Week 6

• Eyebrow Excursion

  week 16

Secondary Outcomes (14)

• Duration of Botulinum Toxin Type A Effect

  week 16

• Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale

  Immediately after botox injection

• Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey

  Week 2

• Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey

  Week 6

• Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey

  Week 16

Study Arms (2)

Topical Anesthesia

OTHER

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

Drug: Botulinum toxin type A; Drug: 2.5% lidocaine/2.5% prilocaine

Petrolatum

OTHER

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

Drug: Botulinum toxin type A; Device: petrolatum ointment

Interventions

Botulinum toxin type A DRUG

Botulinum toxin type A will be administered to both sides

Also known as: BTX-A

Petrolatum; Topical Anesthesia

2.5% lidocaine/2.5% prilocaine DRUG

2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead

Also known as: EMLA

Topical Anesthesia

petrolatum ointment DEVICE

petrolatum ointment will be applied to one side of the forehead

Also known as: Aquaphor

Petrolatum

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years of age
• 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

You may not qualify if:

• Previous injection of botulinum toxin in the intended treatment area for the study within the last 4 months
• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Robert Cizik Eye Clinic: collaborator

Study Sites (1)

Robert Cizik Eye Clinic

Houston, Texas, 77030, United States

Location

Related Publications (16)

• 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.

  PMID: 7365644 BACKGROUND

• 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.

  PMID: 9834738 BACKGROUND

• 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.

  PMID: 9279643 BACKGROUND

• 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.

  PMID: 15598005 BACKGROUND

• 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.

  PMID: 7824641 BACKGROUND

• 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.

  PMID: 2748749 BACKGROUND

• 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.

  PMID: 17117100 BACKGROUND

• 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.

  PMID: 24699554 BACKGROUND

• 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.

  PMID: 29016544 BACKGROUND

• 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.

  PMID: 27617615 BACKGROUND

• 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.

  PMID: 21120257 BACKGROUND

• 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.

  PMID: 19454924 BACKGROUND

• 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.

  PMID: 25705950 BACKGROUND

• 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.

  PMID: 15507786 BACKGROUND

• 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.

  PMID: 17376126 BACKGROUND

• 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.

  PMID: 15710113 BACKGROUND

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Karina Richani-Reverol, MD
• Organization: The University of Texas Health Science Center at Houston

Karina.RichaniReverol@uth.tmc.edu

(713) 559-5200

Study Officials

• Karina Richani-Reverol, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization will only be known by the principal investigator performing the injections and will not be disclosed to the participants or the brow excursion examiner.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 10, 2019
• Study Start: January 4, 2019
• Primary Completion: June 14, 2019
• Study Completion: June 14, 2019
• Last Updated: June 18, 2020
• Results First Posted: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)