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| Name | Class |
|---|---|
| Robert Cizik Eye Clinic | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | Botulinum toxin type A will be administered to both sides |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karina Richani-Reverol, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Cizik Eye Clinic | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7365644 | Background | 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. | |
| 9834738 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | millimeters | Baseline | side of forehead (either left or right) | side of forehead (either left or right) |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karina Richani-Reverol, MD | The University of Texas Health Science Center at Houston | (713) 559-5200 | Karina.RichaniReverol@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2018 | May 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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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.
| 2.5% lidocaine/2.5% prilocaine | Drug | 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead |
|
|
| petrolatum ointment | Device | petrolatum ointment will be applied to one side of the forehead |
|
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 9279643 | 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. |
| 15598005 | 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. |
| 7824641 | 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. |
| 2748749 | 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. |
| 17117100 | 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. |
| 24699554 | 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. |
| 29016544 | 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. |
| 27617615 | 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. |
| 21120257 | 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. |
| 19454924 | 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. |
| 25705950 | 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. |
| 15507786 | 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. |
| 17376126 | 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. |
| 15710113 | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Distance between both lateral canthi | Mean | Standard Deviation | millimeters |
|
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
|
|
| 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. | Posted | Mean | Standard Deviation | millimeters | Week 2 | side of forehead (either left or right) | side of forehead (either left or right) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | millimeters | Week 6 | side of forehead (either left or right) | side of forehead (either left or right) |
|
|
|
| Primary | Eyebrow Excursion | Posted | Mean | Standard Deviation | millimeters | week 16 | side of forehead (either left or right) | side of forehead (either left or right) |
|
|
|
| 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. | Posted | Mean | Standard Error | weeks | week 16 | side of forehead (either left or right) | side of forehead (either left or right) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately after botox injection | side of forehead (either left or right) | side of forehead (either left or right) |
|
|
|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | Week 16 |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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 | 0 | 14 | 0 | 14 | 0 | 14 |
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| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| dissatisfied |
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| very dissatisfied |
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| dissatisfied |
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| very dissatisfied |
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| dissatisfied |
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| very dissatisfied |
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| dissatisfied |
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| very dissatisfied |
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| dissatisfied |
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| very dissatisfied |
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| dissatisfied |
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| very dissatisfied |
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| dissatisfied |
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| very dissatisfied |
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| dissatisfied |
|
| very dissatisfied |
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| dissatisfied |
|
| very dissatisfied |
|