Direct Brow LiftNCT04383912
Onabotulinum Toxin A in Direct Brow Lift
A study testing Botox Injectable Product in people with Direct Brow Lift and Scarring, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The brow lift is a surgical procedure that has been practiced for several decades. A typical indication is brow ptosis, which can be secondary to involutional changes or facial nerve palsies. Several techniques have been described, including direct, mid-forehead, coronal, and endoscopic approaches. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Direct Brow Lift, Scarring
- What is being tested?
- Botox Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 18 Nov 2020to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be over 18 years of age
- Participants must be able to attend outpatient appointments at the Victoria General Hospital
- Participants must be able to give informed consent
Who cannot join
- Known allergy to botulinum toxin
- Previous scarring in same region of surgical procedure
- Previous botulinum toxin injection within 6 months of surgical date for direct brow lift
- Currently pregnant or breast feeding
- History of keloid or hypertrophic scarring
- History of myasthenia gravis/ neuromotor disorder
Trial locations and contacts
1 site in 1 country.
Canada1 site
Eye Care Centre, Victoria General Hospital
Halifax, Nova Scotia, B3H 2Y9
About this study
Official title: Onabotulinum Toxin A to Improve Direct Brow Lift Outcomes
The brow lift is a surgical procedure that has been practiced for several decades. A typical indication is brow ptosis, which can be secondary to involutional changes or facial nerve palsies. Several techniques have been described, including direct, mid-forehead, coronal, and endoscopic approaches. Of these options, the direct brow lift allows for predictable post-operative brow contour and excellent control over the degree of lift achieved. As with any surgical procedure, with direct brow lift comes known undesirable post-operative outcomes, the most common of which is forehead paresthesia from supraorbital nerve damage. Other complications include alopecia and brow asymmetry. However, one of the main critiques of direct brow lift remains the poor cosmesis that can result from scarring just above the brow. A study conducted by Cho et al. concluded that of the main surgical techniques currently employed for treatment of brow ptosis, direct brow lifts held the highest rates of visible scarring.
Scarring can significantly impair an individuals' quality of life. This is particularly true of facial scarring, which is often difficult to conceal. Much research has been conducted in the area of treating postoperative, traumatic, and burn-related scarring. Cadet et al completed a randomized controlled trial using topical silicone gel for direct brow lift-related scarring, given the known benefit of silicone gel sheeting for the same, but did not find a significant difference between treatment and control groups. Some effective techniques described in the literature to date include long-pulsed non-ablative Nd:YAG laser, as well as intralesional steroid injection. On the rise are studies looking into the use of botulinum toxin A for treatment of unfavourable scarring and improved facial cosmesis.
Read more
Botulinum toxin is a neuromodulatory agent that has garnered usage in a variety of therapeutic and cosmetic settings. More recently, injection of botulinum toxin as a means to reduce scarring and improve outcomes in wound healing has been investigated. Several studies, including two large metaanalyses, have shown this to be an effective method of treatment. Proposed mechanisms include increased apoptosis and suppressed proliferation of fibroblasts treated with botulinum toxin, modulated via the PTEN/PI3K/Akt pathway. Park et al added to the in vitro literature by demonstrating that fibroblasts treated with botulinum toxin A produced fewer extracellular matrix proteins and pro-fibrotic factors compared to untreated cells. Another underlying mechanism that results in suboptimal wound healing is the constant contraction and relaxation of facial muscles, causing repetitive microtrauma that ultimately increases inflammation and impairs wound healing. It therefore stands to reason that by temporarily paralyzing local musculature during the post-operative period, collagen maturation can take place uninterrupted by excessive tensile forces.
Despite scarring being a widely known and undesirable complication of direct brow lift surgery, there have been no studies to date examining the use of onabotulinum toxin injection to reduce said scarring and improve outcomes. With this double masked, prospective, randomized controlled trial, the investigators aim to determine whether injection of onabotulinum toxin immediately following direct brow lift surgery can improve scores on validated patient and observer scar scales.
- Conditions
- Direct Brow Lift, Scarring
- Being tested
- Botox Injectable Product, No intervention (placebo)
- Keywords
- onabotulinum toxin, direct brow lift, scarring, Botox
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox Injectable ProductDrug
The side randomized to receive treatment will be injected with onabotulinum toxin A. Wound healing, scar characteristics, and patient satisfaction will be assessed post operatively. Scarring will be assessed by the patient, medical observers and a lay observer, all masked to the treatment vs placebo side. Standardized scales will be used, and pre-operative, intra-operative, and post-operative photographs will be taken for all participants. ImageJ software will be used to analyze the photos and measure the degree of brow lift achieved on each side, to ensure this has not been affected by onabotulinum toxin injection.
No intervention (placebo)Other
This group (of brows) will be receiving placebo injections containing normal saline. They will be assessed in the same manner as the treatment side.
| Study group | Role | What they receive |
|---|---|---|
| onabotulinum toxin A group (brow) | Experimental | Product name: Onabotulinum toxin A (Botox A, Allergan), 50 unit vials Product code: 93094EC
Description: The side randomized to treatment will receive an injection of 20 units of onabotulinum toxin A as the final step of a direct brow lift surgery. The surgeon will visually divide the surgical incision in half, and divide the volume of the injection evenly between the two sides. This will be a one time administration. Receives: Drug: Botox Injectable Product |
| placebo group (brow) | Placebo comparator | Product name: normal saline
Description: The side randomized to placebo will receive an injection of normal saline as the final step of a direct brow lift surgery. The surgeon will visually divide the surgical incision in half, and divide the volume of the injection evenly between the two sides. This will be a one time administration. Receives: Other: No intervention (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of onabotulinum toxin A on scarring in direct brow lift surgery
- At 1 month following surgery, photographs will be taken of both brows. The patient will then be given a mirror, and under consistent lighting conditions and in a private setting, will complete the Patient Scar Assessment Scale (PSAS) and Visual Analog Scale (VAS), after adequate explanation of each parameter. These scores will be combined for a total score ranging from 7 to 70, again with lower numbers indicating higher patient satisfaction. A masked lay observer (consistent person with every patient) will also complete the VAS.
- The above step will be repeated at 3 months, 6 months, and 12 months after surgery, as well as the following additional steps. Scars will be graded by a masked observer using the Observer Scar Assessment Scale (OSAS), Observer Modified Scar Assessment Scale (OMSAS), and Visual Analog Scale (VAS). These scores will be combined for a total score ranging from 11 to 81, with lower scores indicating better outcome.
Measured: 1 to 12 months
Degree of brow lift achieved
Pre-operative, intra-operative, and post-operative (at month 1, 3, 6, and 12) photographs will be taken for all participants. ImageJ software will be used to analyze the photos and measure the degree of brow lift achieved on each side, to ensure this has not been affected by botulinum toxin injection. This will be measured from the pupillary light reflex to the upper border of the eyebrow (in mm). These measurements will be done by a masked observer.
Measured: Pre-operative to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start18 Nov 2020
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Direct Brow LiftStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double masked, prospective, randomized controlled trial. Participants will function as their own internal control, with one side (i.e. brow) being randomized to the treatment arm, and the other to placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Principal investigator, Ahsen Hussain, Nova Scotia Health Authority
- Investigators
- Ahsen Hussain, FRCOphth, MD, Principal investigator, Staff surgeon (ophthalmic plastic and reconstructive surgery)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383912
- Sponsor's protocol ID
- Botox Direct Brow Lift
- Status last verified
- Feb 2024
- First submitted
- 1 May 2020
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Booth AJ, Murray A, Tyers AG. The direct brow lift: efficacy, complications, and patient satisfaction. Br J Ophthalmol. 2004 May;88(5):688-91. doi: 10.1136/bjo.2003.019232.
PubMed 15090424Cho MJ, Carboy JA, Rohrich RJ. Complications in Brow Lifts: A Systemic Review of Surgical and Nonsurgical Brow Rejuvenations. Plast Reconstr Surg Glob Open. 2018 Oct 15;6(10):e1943. doi: 10.1097/GOX.0000000000001943. eCollection 2018 Oct.
PubMed 30534495Price P, Tebble N. Psychological consequences of facial scarring. Chapter from Surgery in Wounds 2004, 519-526.
Cadet N, Hardy I, Dudek D, Miszkiewicz K, Boulos P, Nguyen Q, Wong J. Prospective case-control trial evaluating silicone gel for the treatment of direct brow lift scars. Can J Ophthalmol. 2018 Feb;53(1):29-33. doi: 10.1016/j.jcjo.2017.07.017.
PubMed 29426436Tenzel PA, Patel K, Erickson BP, Shriver EM, Grunebaum LD, Alabiad CR, Lee WW, Wester ST. Split face evaluation of long-pulsed non-ablative 1,064 nm Nd:YAG laser for treatment of direct browplasty scars. Lasers Surg Med. 2016 Oct;48(8):742-747. doi: 10.1002/lsm.22543. Epub 2016 Aug 9.
PubMed 27505684Trisliana Perdanasari A, Torresetti M, Grassetti L, Nicoli F, Zhang YX, Dashti T, Di Benedetto G, Lazzeri D. Intralesional injection treatment of hypertrophic scars and keloids: a systematic review regarding outcomes. Burns Trauma. 2015 Aug 26;3:14. doi: 10.1186/s41038-015-0015-7. eCollection 2015.
PubMed 27574660Guo X, Song G, Zhang D, Jin X. Efficacy of Botulinum Toxin Type A in Improving Scar Quality and Wound Healing: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Aesthet Surg J. 2020 Apr 14;40(5):NP273-NP285. doi: 10.1093/asj/sjz165.
PubMed 31155638Yang W, Li G. The Safety and efficacy of botulinum toxin type A injection for postoperative scar prevention: A systematic review and meta-analysis. J Cosmet Dermatol. 2020 Apr;19(4):799-808. doi: 10.1111/jocd.13139. Epub 2019 Sep 12.
PubMed 31513335Zhang X, Lan D, Ning S, Jia H, Yu S. Botulinum toxin type A prevents the phenotypic transformation of fibroblasts induced by TGF-beta1 via the PTEN/PI3K/Akt signaling pathway. Int J Mol Med. 2019 Aug;44(2):661-671. doi: 10.3892/ijmm.2019.4226. Epub 2019 May 31.
PubMed 31173164Park GS, An MK, Yoon JH, Park SS, Koh SH, Mauro TM, Cho EB, Park EJ, Kim KH, Kim KJ. Botulinum toxin type A suppresses pro-fibrotic effects via the JNK signaling pathway in hypertrophic scar fibroblasts. Arch Dermatol Res. 2019 Dec;311(10):807-814. doi: 10.1007/s00403-019-01975-0. Epub 2019 Sep 9.
PubMed 31501922Shome D, Khare S, Kapoor R. An Algorithm Using Botox Injections for Facial Scar Improvement in Fitzpatrick Type IV-VI Skin. Plast Reconstr Surg Glob Open. 2018 Aug 8;6(8):e1888. doi: 10.1097/GOX.0000000000001888. eCollection 2018 Aug.
PubMed 30324067Tyers AG, Collin JRO. In: Colour atlas of ophthalmic plastic surgery. 2nd ed. Oxford: Butterworth-Heinemann, 1997, 178-82.
Ziade M, Domergue S, Batifol D, Jreige R, Sebbane M, Goudot P, Yachouh J. Use of botulinum toxin type A to improve treatment of facial wounds: a prospective randomised study. J Plast Reconstr Aesthet Surg. 2013 Feb;66(2):209-14. doi: 10.1016/j.bjps.2012.09.012. Epub 2012 Oct 25.
PubMed 23102873
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onabotulinum Toxin A to Improve Direct Brow Lift Outcomes
- ClinicalTrials.gov ID
- NCT04383912
- Acronym / sponsor ID
- Botox Direct Brow Lift
- Conditions
- Direct Brow Lift, Scarring
- Keywords
- onabotulinum toxin, direct brow lift, scarring, Botox
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The brow lift is a surgical procedure that has been practiced for several decades. A typical indication is brow ptosis, which can be secondary to involutional changes or facial nerve palsies. Several techniques have been described, including direct, mid-forehead, coronal, and endoscopic approaches. Of these options, the direct brow lift allows for predictable post-operative brow contour and excellent control over the degree of lift achieved. As with any surgical procedure, with direct brow lift comes known undesirable post-operative outcomes, the most common of which is forehead paresthesia from supraorbital nerve damage. Other complications include alopecia and brow asymmetry. However, one of the main critiques of direct brow lift remains the poor cosmesis that can result from scarring just above the brow. A study conducted by Cho et al. concluded that of the main surgical techniques currently employed for treatment of brow ptosis, direct brow lifts held the highest rates of visible scarring.
Scarring can significantly impair an individuals' quality of life. This is particularly true of facial scarring, which is often difficult to conceal. Much research has been conducted in the area of treating postoperative, traumatic, and burn-related scarring. Cadet et al completed a randomized controlled trial using topical silicone gel for direct brow lift-related scarring, given the known benefit of silicone gel sheeting for the same, but did not find a significant difference between treatment and control groups. Some effective techniques described in the literature to date include long-pulsed non-ablative Nd:YAG laser, as well as intralesional steroid injection. On the rise are studies looking into the use of botulinum toxin A for treatment of unfavourable scarring and improved facial cosmesis.
Botulinum toxin is a neuromodulatory agent that has garnered usage in a variety of therapeutic and cosmetic settings. More recently, injection of botulinum toxin as a means to reduce scarring and improve outcomes in wound healing has been investigated. Several studies, including two large metaanalyses, have shown this to be an effective method of treatment. Proposed mechanisms include increased apoptosis and suppressed proliferation of fibroblasts treated with botulinum toxin, modulated via the PTEN/PI3K/Akt pathway. Park et al added to the in vitro literature by demonstrating that fibroblasts treated with botulinum toxin A produced fewer extracellular matrix proteins and pro-fibrotic factors compared to untreated cells. Another underlying mechanism that results in suboptimal wound healing is the constant contraction and relaxation of facial muscles, causing repetitive microtrauma that ultimately increases inflammation and impairs wound healing. It therefore stands to reason that by temporarily paralyzing local musculature during the post-operative period, collagen maturation can take place uninterrupted by excessive tensile forces.
Despite scarring being a widely known and undesirable complication of direct brow lift surgery, there have been no studies to date examining the use of onabotulinum toxin injection to reduce said scarring and improve outcomes. With this double masked, prospective, randomized controlled trial, the investigators aim to determine whether injection of onabotulinum toxin immediately following direct brow lift surgery can improve scores on validated patient and observer scar scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double masked, prospective, randomized controlled trial. Participants will function as their own internal control, with one side (i.e. brow) being randomized to the treatment arm, and the other to placebo.
| Arm | Type | Receives |
|---|---|---|
| onabotulinum toxin A group (brow) | Experimental | Drug: Botox Injectable ProductProduct name: Onabotulinum toxin A (Botox A, Allergan), 50 unit vials Product code: 93094EC Description: The side randomized to treatment will receive an injection of 20 units of onabotulinum toxin A as the final step of a direct brow lift surgery. The surgeon will visually divide the surgical incision in half, and divide the volume of the injection evenly between the two sides. This will be a one time administration. |
| placebo group (brow) | Placebo comparator | Other: No intervention (placebo)Product name: normal saline Description: The side randomized to placebo will receive an injection of normal saline as the final step of a direct brow lift surgery. The surgeon will visually divide the surgical incision in half, and divide the volume of the injection evenly between the two sides. This will be a one time administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be over 18 years of age
- Participants must be able to attend outpatient appointments at the Victoria General Hospital
- Participants must be able to give informed consent
Key exclusion criteria (6 listed)
- Known allergy to botulinum toxin
- Previous scarring in same region of surgical procedure
- Previous botulinum toxin injection within 6 months of surgical date for direct brow lift
- Currently pregnant or breast feeding
- History of keloid or hypertrophic scarring
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 |
|---|---|---|
| Botox Injectable ProductThe side randomized to receive treatment will be injected with onabotulinum toxin A. Wound healing, scar characteristics, and patient satisfaction will be assessed post operatively. Scarring will be assessed by the patient, medical observers and a lay observer, all masked to the treatment vs placebo side. Standardized scales will be used, and pre-operative, intra-operative, and post-operative photographs will be taken for all participants. ImageJ software will be used to analyze the photos and measure the degree of brow lift achieved on each side, to ensure this has not been affected by onabotulinum toxin injection. | Drug | onabotulinum toxin A group (brow) |
| No intervention (placebo)This group (of brows) will be receiving placebo injections containing normal saline. They will be assessed in the same manner as the treatment side. | Other | placebo group (brow) |
Primary outcome
Effect of onabotulinum toxin A on scarring in direct brow lift surgery
Time frame: 1 to 12 months
* At 1 month following surgery, photographs will be taken of both brows. The patient will then be given a mirror, and under consistent lighting conditions and in a private setting, will complete the Patient Scar Assessment Scale (PSAS) and Visual Analog Scale (VAS), after adequate explanation of each parameter. These scores will be combined for a total score ranging from 7 to 70, again with lower numbers indicating higher patient satisfaction. A masked lay observer (consistent person with every patient) will also complete the VAS. * The above step will be repeated at 3 months, 6 months, and 12 months after surgery, as well as the following additional steps. Scars will be graded by a masked observer using the Observer Scar Assessment Scale (OSAS), Observer Modified Scar Assessment Scale (OMSAS), and Visual Analog Scale (VAS). These scores will be combined for a total score ranging from 11 to 81, with lower scores indicating better outcome.
Degree of brow lift achieved
Time frame: Pre-operative to 12 months
Pre-operative, intra-operative, and post-operative (at month 1, 3, 6, and 12) photographs will be taken for all participants. ImageJ software will be used to analyze the photos and measure the degree of brow lift achieved on each side, to ensure this has not been affected by botulinum toxin injection. This will be measured from the pupillary light reflex to the upper border of the eyebrow (in mm). These measurements will be done by a masked observer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 15090424Booth AJ, Murray A, Tyers AG. The direct brow lift: efficacy, complications, and patient satisfaction. Br J Ophthalmol. 2004 May;88(5):688-91. doi: 10.1136/bjo.2003.019232.
- Background: PubMed 30534495Cho MJ, Carboy JA, Rohrich RJ. Complications in Brow Lifts: A Systemic Review of Surgical and Nonsurgical Brow Rejuvenations. Plast Reconstr Surg Glob Open. 2018 Oct 15;6(10):e1943. doi: 10.1097/GOX.0000000000001943. eCollection 2018 Oct.
- BackgroundPrice P, Tebble N. Psychological consequences of facial scarring. Chapter from Surgery in Wounds 2004, 519-526.
- Background: PubMed 29426436Cadet N, Hardy I, Dudek D, Miszkiewicz K, Boulos P, Nguyen Q, Wong J. Prospective case-control trial evaluating silicone gel for the treatment of direct brow lift scars. Can J Ophthalmol. 2018 Feb;53(1):29-33. doi: 10.1016/j.jcjo.2017.07.017.
- Background: PubMed 27505684Tenzel PA, Patel K, Erickson BP, Shriver EM, Grunebaum LD, Alabiad CR, Lee WW, Wester ST. Split face evaluation of long-pulsed non-ablative 1,064 nm Nd:YAG laser for treatment of direct browplasty scars. Lasers Surg Med. 2016 Oct;48(8):742-747. doi: 10.1002/lsm.22543. Epub 2016 Aug 9.
- Background: PubMed 27574660Trisliana Perdanasari A, Torresetti M, Grassetti L, Nicoli F, Zhang YX, Dashti T, Di Benedetto G, Lazzeri D. Intralesional injection treatment of hypertrophic scars and keloids: a systematic review regarding outcomes. Burns Trauma. 2015 Aug 26;3:14. doi: 10.1186/s41038-015-0015-7. eCollection 2015.
- Background: PubMed 31155638Guo X, Song G, Zhang D, Jin X. Efficacy of Botulinum Toxin Type A in Improving Scar Quality and Wound Healing: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Aesthet Surg J. 2020 Apr 14;40(5):NP273-NP285. doi: 10.1093/asj/sjz165.
- Background: PubMed 31513335Yang W, Li G. The Safety and efficacy of botulinum toxin type A injection for postoperative scar prevention: A systematic review and meta-analysis. J Cosmet Dermatol. 2020 Apr;19(4):799-808. doi: 10.1111/jocd.13139. Epub 2019 Sep 12.
- Background: PubMed 31173164Zhang X, Lan D, Ning S, Jia H, Yu S. Botulinum toxin type A prevents the phenotypic transformation of fibroblasts induced by TGF-beta1 via the PTEN/PI3K/Akt signaling pathway. Int J Mol Med. 2019 Aug;44(2):661-671. doi: 10.3892/ijmm.2019.4226. Epub 2019 May 31.
- Background: PubMed 31501922Park GS, An MK, Yoon JH, Park SS, Koh SH, Mauro TM, Cho EB, Park EJ, Kim KH, Kim KJ. Botulinum toxin type A suppresses pro-fibrotic effects via the JNK signaling pathway in hypertrophic scar fibroblasts. Arch Dermatol Res. 2019 Dec;311(10):807-814. doi: 10.1007/s00403-019-01975-0. Epub 2019 Sep 9.
- Background: PubMed 30324067Shome D, Khare S, Kapoor R. An Algorithm Using Botox Injections for Facial Scar Improvement in Fitzpatrick Type IV-VI Skin. Plast Reconstr Surg Glob Open. 2018 Aug 8;6(8):e1888. doi: 10.1097/GOX.0000000000001888. eCollection 2018 Aug.
- BackgroundTyers AG, Collin JRO. In: Colour atlas of ophthalmic plastic surgery. 2nd ed. Oxford: Butterworth-Heinemann, 1997, 178-82.
- Individual participant dataSharing planned: No
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.
Ahsen Hussain, FRCOphth, MD principal investigator
Staff surgeon (ophthalmic plastic and reconstructive surgery)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botox Injectable Product in people with Direct Brow Lift and Scarring, run by Nova Scotia Health Authority at 1 site in Canada.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Feb 2024. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Effect of onabotulinum toxin A on scarring in direct brow lift surgery (time frame: 1 to 12 months). The study lists 2 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 NCT04383912, which also lists 13 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 6 Feb 2024.