Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

Forehead Wrinkles Clinical Trial

Official title:

Randomized, Single Center, Masked Study Comparing the Efficacy of Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03799484
• Other study ID #: HSC-MS-18-0908
• Status: Completed
• Phase: Phase 4
• Start date: January 4, 2019
• Est. completion date: June 14, 2019

Study information

• Verified date: June 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, randomized, double-masked, comparative study in patients who present at the Robert Cizik Eye Clinic with horizontal forehead rhytides requiring treatment with botulinum toxin Type A (Botox ®; Allergan, Irvine, CA, USA).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 14, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Forehead Rhytides
• Forehead Wrinkles

Intervention

Drug:
• 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

Device:
• petrolatum ointment
petrolatum ointment will be applied to one side of the forehead

Locations

Country	Name	City	State
United States	Robert Cizik Eye Clinic	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Robert Cizik Eye Clinic

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. Review. — View Citation

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. — View Citation

Carruthers A, Carruthers J. Aesthetic indications for botulinum toxin injections. Plast Reconstr Surg. 1995 Feb;95(2):427-8. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Carter SR, Seiff SR. Cosmetic botulinum toxin injections. Int Ophthalmol Clin. 1997 Summer;37(3):69-79. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Oct 6. doi: 10.1097/DSS.0000000000001349. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

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). pii: 13030/qt38b203d0. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Eyebrow Excursion		week 16
Secondary	Duration of Botulinum Toxin Type A Effect	Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value.	week 16
Secondary	Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale	A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome.	Immediately after botox injection
Secondary	Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.	Week 2
Secondary	Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.	Week 6
Secondary	Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.	Week 16
Secondary	Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.	Week 2
Secondary	Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.	Week 6
Secondary	Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.	Week 16
Secondary	Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.	Week 2
Secondary	Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.	Week 6
Secondary	Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.	Week 16
Secondary	Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face	Participants will be asked if there is a noticeable difference between the 2 sides of their face.	Week 2
Secondary	Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face	Participants will be asked if there is a noticeable difference between the 2 sides of their face.	Week 6
Secondary	Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face	Participants will be asked if there is a noticeable difference between the 2 sides of their face.	Week 16