Forehead RhytidesPhase 4NCT03799484
Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
A Phase 4 study testing Botulinum toxin type A, 2.5% lidocaine/2.5% prilocaine and petrolatum ointment in people with Forehead Rhytides and Forehead Wrinkles, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Forehead Rhytides, Forehead Wrinkles
- What is being tested?
- Botulinum toxin type A, 2.5% lidocaine/2.5% prilocaine and petrolatum ointment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2019to 14 Jun 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Single Center, Masked Study Comparing the Efficacy of Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
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.
Read the detailed 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
- Conditions
- Forehead Rhytides, Forehead Wrinkles
- Being tested
- Botulinum toxin type A, 2.5% lidocaine/2.5% prilocaine, petrolatum ointment
- Keywords
- Rhytides, Forehead Wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called BTX-A
Botulinum toxin type A will be administered to both sides
2.5% lidocaine/2.5% prilocaineDrug
Also called EMLA
2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead
petrolatum ointmentDevice
Also called Aquaphor
petrolatum ointment will be applied to one side of the forehead
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Botulinum toxin type A; Device: petrolatum ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 6
Eyebrow Excursion
Measured: week 16
Secondary outcomes (14)
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.
Measured: week 16
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start4 Jan 2019
- Primary completion14 Jun 2019
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Forehead RhytidesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Cizik Eye Clinic
- Responsible party
- Principal investigator, Karina Richani-Reverol, The University of Texas Health Science Center, Houston
- Investigators
- Karina Richani-Reverol, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799484
- Sponsor's protocol ID
- HSC-MS-18-0908
- Status last verified
- Jun 2020
- First submitted
- 3 Jan 2019
- Last updated
- 18 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7365644Carruthers 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.
PubMed 9834738Carter 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.
PubMed 9279643Charles 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.
PubMed 15598005Carruthers 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.
PubMed 7824641Clark RP, Berris CE. Botulinum toxin: a treatment for facial asymmetry caused by facial nerve paralysis. Plast Reconstr Surg. 1989 Aug;84(2):353-5.
PubMed 2748749Sami 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.
PubMed 17117100Gordin 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.
PubMed 24699554Li 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.
PubMed 29016544Shi 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.
PubMed 27617615Baumann 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.
PubMed 21120257Weiss 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.
PubMed 19454924Alam 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.
PubMed 25705950Carruthers 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.
PubMed 15507786Ito 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.
PubMed 17376126
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single Center, Masked Study Comparing the Efficacy of Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
- ClinicalTrials.gov ID
- NCT03799484
- Acronym / sponsor ID
- HSC-MS-18-0908
- Conditions
- Forehead Rhytides, Forehead Wrinkles
- Keywords
- Rhytides, Forehead Wrinkles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Robert Cizik Eye Clinic
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Posted 18 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Anesthesia | Other | Drug: Botulinum toxin type A, Drug: 2.5% lidocaine/2.5% prilocaine2.5% 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 | Drug: Botulinum toxin type A, Device: petrolatum ointmentPetrolatum 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AAlso: BTX-ABotulinum toxin type A will be administered to both sides | Drug | Petrolatum, Topical Anesthesia |
| 2.5% lidocaine/2.5% prilocaineAlso: EMLA2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead | Drug | Topical Anesthesia |
| petrolatum ointmentAlso: Aquaphorpetrolatum ointment will be applied to one side of the forehead | Device | Petrolatum |
Primary outcome
Eyebrow Excursion
Time frame: Baseline
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.
Eyebrow Excursion
Time frame: Week 2
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.
Eyebrow Excursion
Time frame: Week 6
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.
Eyebrow Excursion
Time frame: week 16
14 secondary outcomes
Duration of Botulinum Toxin Type A Effect
Time frame: week 16
Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale
Time frame: Immediately after botox injection
Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey
Time frame: Week 2
Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey
Time frame: Week 6
Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey
Time frame: Week 16
Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey
Time frame: Week 2
Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey
Time frame: Week 6
Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey
Time frame: Week 16
Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey
Time frame: Week 2
Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey
Time frame: Week 6
Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey
Time frame: Week 16
Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
Time frame: Week 2
Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
Time frame: Week 6
Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7365644Scott 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.
- Background: PubMed 9834738Carruthers 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.
- Background: PubMed 9279643Carter 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.
- Background: PubMed 15598005Charles 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.
- Background: PubMed 7824641Carruthers 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.
- Background: PubMed 2748749Clark RP, Berris CE. Botulinum toxin: a treatment for facial asymmetry caused by facial nerve paralysis. Plast Reconstr Surg. 1989 Aug;84(2):353-5.
- Background: PubMed 17117100Sami 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.
- Background: PubMed 24699554Gordin 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.
- Background: PubMed 29016544Li 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.
- Background: PubMed 27617615Shi 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.
- Background: PubMed 21120257Baumann 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.
- Background: PubMed 19454924Weiss 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karina Richani-Reverol, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin type A, 2.5% lidocaine/2.5% prilocaine and petrolatum ointment in people with Forehead Rhytides and Forehead Wrinkles, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyebrow Excursion (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03799484, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.