Skin ScarringPhase 2NCT06465056
Use of Botulinum Toxin A in Direct Eyebrow Lift Scar
A Phase 2 study testing Botulinum toxin type A in people with Skin Scarring and Eyebrow Ptosis, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
Prospective, controlled and randomized study in which participants indicated for surgery to direct eyebrow lift will be randomized into two groups. In addition to surgery, the patients will be treated with botulinum toxin in one eyebrow and saline (placebo) in the other site. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Scarring, Eyebrow Ptosis
- What is being tested?
- Botulinum toxin type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Jan 2024to 1 Jan 2026
- Phase
- Phase 2
- 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
- Patients over 18 years of age with indication for direct eyebrow lift surgery.
Who cannot join
- Vulnerable groups: children, pregnant women and immunosuppressed patients
- Allergy to botulinum toxin A
- Patients under 18 years old
- Women who are breastfeeding
- Patients with muscular/neuromuscular diseases such as myasthenia gravis and amyotrophic lateral sclerosis
- Patients who underwent botulinum toxin A injection in the last 6 months prior to surgery
- Patients with a history of radiotherapy, chemotherapy or hematological disorders
- Refusal to participate in the study
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
University of São Paulo (Clinical Hospital)
São Paulo, 05403-010
Renata D. Lemos, MD, MMed, rdinizlemos@gmail.com
- Recruiting
Ophthalmology Dept. University of Sao Paulo General Hospital
São Paulo, 05403010
Suzana Matayoshi, MD
About this study
Official title: Use of Botulinum Toxin A in Direct Eyebrow Lift Scar: a Randomized Controlled Clinical Trial
Prospective, controlled and randomized study in which participants indicated for surgery to direct eyebrow lift will be randomized into two groups. In addition to surgery, the patients will be treated with botulinum toxin in one eyebrow and saline (placebo) in the other site. The patients participate as treatment and placebo at the same time. Assessments will be carried out through non-invasive exams.
Read the detailed description
A component of eyebrow ptosis, part of the natural aging process, with or without asymmetries, is found in the majority of patients who seek the blepharoplasty procedure.
There are several procedures to address this condition, but none of them is undoubtedly superior to the others. The direct eyebrow lift technique is known for providing good eyebrow suspension, predictable results and relatively low complexity surgery, which can be performed with local anesthesia.
However, the biggest concern for surgeons and patients is the final appearance of the scar, which will be in a visible area of the face. Botulinum toxin A has been used in recent studies precisely to improve the appearance of scars. Previous studies mainly evaluated traumatic lacerations and post-tumor excision reconstructions, obtaining positive results, with an improvement in the appearance of the wounds in patients who used the medication. It is a safe drug, used for several years for other purposes and without serious adverse effects according to these studies.
The objective of this study is to compare the use of botulinum toxin A versus 0.9% saline solution in the healing of direct eyebrow lift surgery.
- Conditions
- Skin Scarring, Eyebrow Ptosis
- Being tested
- Botulinum toxin type A
- Keywords
- Botulinum Toxin A, Direct eyebrow lift, Eyebrow scar
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin application between 3-14 days after direct eyebrow lift surgery.
| Study group | Role | What they receive |
|---|---|---|
| Right side treatment | Active comparator | Patients receive botulinum toxin A in right side eyebrow scar and saline in left side scar. Receives: Drug: Botulinum toxin type A |
| Left side treatment | Active comparator | Patients receive botulinum toxin A in left side eyebrow scar and saline in right side scar. Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar evaluation 1
Eyebrow direct lift scar evaluation, comparing botulinum toxin A side with saline side, using the following assessment scale: Visual Analogue Scale Score (VAS). The VAS is described as a quick and practical way of evaluating the patient's experience in relation to pain, on a scale of 0 to 100 millimeters, ranging from no pain to the worst pain imaginable.17 Due to the ease and simplicity of its application, it is used in several studies to evaluate various parameters, even if not consistent with their original validation. Here it will be using meaning 0 (no scar) and 100 milimeters (worst scar imaginable).
Measured: One month, three months and six months after surgery
Scar evaluation 2
Eyebrow direct lift scar evaluation, comparing botulinum toxin A side with saline side, using the following assessment scale: Vancouver Scar Scale (VSS). The VSS ranges from 0 (best) to 13 (worst) points, evaluating vascular distribution, thickness, flexibility and pigmentation.
Measured: One month, three months and six months after surgery
Scar evaluation 3
Eyebrow direct lift scar evaluation, comparing botulinum toxin A side with saline side, using the following assessment scale: Stony Brook Scar Evaluation Scales (SBSESs). The SBSES was developed for short-term assessment of repaired burns, and is described as useful for assessment of suture scars. It consists of five indicators: length, elevation or depression, color, suture or staple marks and general appearance. Your score ranges from 0 (worst) to 5 (best)
Measured: One month, three months and six months after surgery
Scar evaluation 4
Eyebrow direct lift scar evaluation, comparing botulinum toxin A side with saline side, using the following assessment scale: Patient and Observer Scar Assessment Scale (POSAS).
POSAS was developed in 2004 and is the first scale to consider the perspective of the patient and the evaluator. It is useful in evaluating postoperative and linear scars, ranging from 5 (worst) to 50 (best). It encompasses physical properties of scars such as vascularity, pigmentation, thickness, relief and flexibility, in addition to two patient symptoms, pain and itching.
Measured: One month, three months and six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ScarringStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil, Faculdade de Medicina do ABC
- Responsible party
- Principal investigator, Suzana Matayoshi, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465056
- Sponsor's protocol ID
- 73675523.7.0000.0068
- Status last verified
- Jun 2024
- First submitted
- 26 May 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Botulinum Toxin A in Direct Eyebrow Lift Scar: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06465056
- Acronym / sponsor ID
- 73675523.7.0000.0068
- Conditions
- Skin Scarring, Eyebrow Ptosis
- Keywords
- Botulinum Toxin A, Direct eyebrow lift, Eyebrow scar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil, Faculdade de Medicina do ABC
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 18 Jun 2024 (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.
Prospective, controlled and randomized study in which participants indicated for surgery to direct eyebrow lift will be randomized into two groups. In addition to surgery, the patients will be treated with botulinum toxin in one eyebrow and saline (placebo) in the other site. The patients participate as treatment and placebo at the same time. Assessments will be carried out through non-invasive exams.
Detailed description
A component of eyebrow ptosis, part of the natural aging process, with or without asymmetries, is found in the majority of patients who seek the blepharoplasty procedure.
There are several procedures to address this condition, but none of them is undoubtedly superior to the others. The direct eyebrow lift technique is known for providing good eyebrow suspension, predictable results and relatively low complexity surgery, which can be performed with local anesthesia.
However, the biggest concern for surgeons and patients is the final appearance of the scar, which will be in a visible area of the face. Botulinum toxin A has been used in recent studies precisely to improve the appearance of scars. Previous studies mainly evaluated traumatic lacerations and post-tumor excision reconstructions, obtaining positive results, with an improvement in the appearance of the wounds in patients who used the medication. It is a safe drug, used for several years for other purposes and without serious adverse effects according to these studies.
The objective of this study is to compare the use of botulinum toxin A versus 0.9% saline solution in the healing of direct eyebrow lift surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right side treatment | Active comparator | Drug: Botulinum toxin type APatients receive botulinum toxin A in right side eyebrow scar and saline in left side scar. |
| Left side treatment | Active comparator | Drug: Botulinum toxin type APatients receive botulinum toxin A in left side eyebrow scar and saline in right side scar. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age with indication for direct eyebrow lift surgery.
Key exclusion criteria (8 listed)
- Vulnerable groups: children, pregnant women and immunosuppressed patients
- Allergy to botulinum toxin A
- Patients under 18 years old
- Women who are breastfeeding
- Patients with muscular/neuromuscular diseases such as myasthenia gravis and amyotrophic lateral sclerosis
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 ABotulinum toxin application between 3-14 days after direct eyebrow lift surgery. | Drug | Left side treatment, Right side treatment |
Primary outcome
Scar evaluation 1
Time frame: One month, three months and six months after surgery
Eyebrow direct lift scar evaluation, comparing botulinum toxin A side with saline side, using the following assessment scale: Visual Analogue Scale Score (VAS). The VAS is described as a quick and practical way of evaluating the patient's experience in relation to pain, on a scale of 0 to 100 millimeters, ranging from no pain to the worst pain imaginable.17 Due to the ease and simplicity of its application, it is used in several studies to evaluate various parameters, even if not consistent with their original validation. Here it will be using meaning 0 (no scar) and 100 milimeters (worst scar imaginable).
Scar evaluation 2
Time frame: One month, three months and six months after surgery
Eyebrow direct lift scar evaluation, comparing botulinum toxin A side with saline side, using the following assessment scale: Vancouver Scar Scale (VSS). The VSS ranges from 0 (best) to 13 (worst) points, evaluating vascular distribution, thickness, flexibility and pigmentation.
Scar evaluation 3
Time frame: One month, three months and six months after surgery
Eyebrow direct lift scar evaluation, comparing botulinum toxin A side with saline side, using the following assessment scale: Stony Brook Scar Evaluation Scales (SBSESs). The SBSES was developed for short-term assessment of repaired burns, and is described as useful for assessment of suture scars. It consists of five indicators: length, elevation or depression, color, suture or staple marks and general appearance. Your score ranges from 0 (worst) to 5 (best)
Scar evaluation 4
Time frame: One month, three months and six months after surgery
Eyebrow direct lift scar evaluation, comparing botulinum toxin A side with saline side, using the following assessment scale: Patient and Observer Scar Assessment Scale (POSAS). POSAS was developed in 2004 and is the first scale to consider the perspective of the patient and the evaluator. It is useful in evaluating postoperative and linear scars, ranging from 5 (worst) to 50 (best). It encompasses physical properties of scars such as vascularity, pigmentation, thickness, relief and flexibility, in addition to two patient symptoms, pain and itching.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin type A in people with Skin Scarring and Eyebrow Ptosis, run by University of Sao Paulo at 2 sites in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Renata Lemos ((11) 2661-7217, rdinizlemos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar evaluation 1 (time frame: One month, three months and six months after surgery). 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?
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 2024.