AgingNCT03836638
The Impact of Age on Botulinum Toxin Potency in Facial Rhytides Treatment
A study testing 30 Units of botulinum toxin and 50 Units of botulinum toxin in people with Aging and Botulinum Toxin, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
Trial summary
Botulinum toxin is approved by the FDA for the treatment of facial wrinkles. Patients are usually older than 45 years and their main demand is to treat pre-existing facial wrinkles. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Botulinum Toxin, Facial Wrinkles
- What is being tested?
- 30 Units of botulinum toxin and 50 Units of botulinum toxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteLebanon
- Study dates
- 1 May 2019to 1 Dec 2020
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female patients presenting to our clinic for Facial wrinkle treatment with botulinum toxin
- Must be between 25-35 years old to be included in group 1.
- Must be older than 45 to be included in groups 2 and 3.
Who cannot join
- Patients with previous periorbital/forehead surgery
- Patients who plucked the upper eyebrow margin
- Patients with eyebrow tatoos
- Patients with upper face botulinum toxin injection in the past 12 months
- Patients with resorbable upper face fillers injection in the past 12 months
- Patients with previous permanent upper face fillers injection
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- Pregnant patients
- Lactating patients
- Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome)
- Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics)
- Patients with sensitivity to botulinum toxin or human albumin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Age on Botulinum Toxin Potency in Facial Rhytides Treatment: A Prospective Randomized Controlled Trial
Botulinum toxin is approved by the FDA for the treatment of facial wrinkles. Patients are usually older than 45 years and their main demand is to treat pre-existing facial wrinkles. However with the increasing popularity of this technique, younger patients, aged 25 to 35 years, are now seeking botulinum toxin injection as a preventive measure for rhytides. The usual dose used for the treatment of facial rhytides in a female patient older than 45 years is 50 units. No consensus exists concerning the dose of botulinum toxin that should be used in younger patients. Hypothesis: lower dose of botulinum toxin is sufficient to give good and long lasting results in young patients. The objective of this randomized open-label study is to evaluate the effect of lower doses of Botulinum toxin on the facial rythides in young patients.
Read the detailed description
Botulinum toxin is approved by the FDA for the treatment of facial wrinkles. Patients are usually older than 45 years and their main demand is to treat pre-existing facial wrinkles. However with the increasing popularity of this technique, younger patients, aged 25 to 35 years, are now seeking botulinum toxin injection as a preventive measure for rhytides. The usual dose used for the treatment of facial rhytides in a female patient older than 45 years is 50 units. No consensus exists concerning the dose of botulinum toxin that should be used in younger patients. Hypothesis: lower dose of botulinum toxin is sufficient to give good and long lasting results in young patients.
The objective of this randomized open-label study is to evaluate the effect of lower doses of Botulinum toxin on the facial rythides in young patients.
In this trial, patients will be divided into 3 groups: Group 1 patients will be 25-35 years old and will be injected with 30 units of botulinum toxin into the upper face, group 2 patients will be older than 45 and will be injected with the same amount of botulinum toxin into the upper face and group 3 patients will be older than 45 and will be treated with the usual 50 units dose (control group). Patients older than 45 will be randomized between groups 2 and 3. Validated photonumeric scales will be used to evaluate the wrinkles at rest and with muscle contraction at 2, 4, 8, 12, 16, 20, 24 weeks post injection in the 3 groups. The patient satisfaction rate and the Physician global assessment will also be evaluated in the 3 groups. The scores will be determined by 3 independent blinded raters.
Hypothesis:
(1) the low dose will be sufficient to treat the group 1 patients and it will be insufficient to treat the group 2 patients. (2) The results will last longer in groups 1 and 3 patients compared to group 2 patients. (3) Group 1 patients treated with low doses of botulinum toxin will have similar results to the group 3 patients treated with the standard dose of botulinum toxin.
- Conditions
- Aging, Botulinum Toxin, Facial Wrinkles
- Being tested
- 30 Units of botulinum toxin, 50 Units of botulinum toxin
- Keywords
- Botulinum Toxin, Rejuvenation, Age, Wrinkles, Rhytidis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 Units of botulinum toxinDrug
30 Units of botulinum toxin to upper face
50 Units of botulinum toxinDrug
50 Units of botulinum toxin to upper face
| Study group | Role | What they receive |
|---|---|---|
| Low dose young subjects | Experimental | Group 1 patients will be 25-35 years old and will be injected with 30 units of botulinum toxin into the upper face Receives: Drug: 30 Units of botulinum toxin |
| Low dose older subjects | Experimental | Group 2 patients will be older than 45 and will be injected with 30 units of botulinum toxin into the upper face Receives: Drug: 30 Units of botulinum toxin |
| high dose older subjects | Active comparator | Group 3 patients will be older than 45 and will be treated with the usual 50 units dose into the upper face (control group) Receives: Drug: 50 Units of botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of scores of Validated photonumeric scales: Brow Positioning Scale at rest
0-Youthful, refreshed look and high-arch eyebrow
- Medium-arch eyebrow
- Slight arch of the eyebrow
- Flat arch of the eyebrow, visibility of folds, and tired appearance
- Flat eyebrow with barely any arch, marked visibility of folds, and very tired appearance.
Measured: 0, 2, 4, 8, 12, 16, 20, 24 weeks
Changes of scores of Validated photonumeric scales: Forehead Lines Scale at rest
0-None
- Minimal
- Moderate
- Deep
- Extreme
Measured: 0, 2, 4, 8, 12, 16, 20, 24 weeks
Changes of scores of Validated photonumeric scales: Forehead Lines Scale with contraction
0-None
- Minimal
- Moderate
- Deep
- Extreme
Measured: 0, 2, 4, 8, 12, 16, 20, 24 weeks
Changes of scores of Validated photonumeric scales: Glabellar Lines Scale at rest
0-No glabella lines
- Mild glabella lines
- Moderate glabella lines
- Severe glabella lines
- Very severe glabella lines
Measured: 0, 2, 4, 8, 12, 16, 20, 24 weeks
Changes of scores of Validated photonumeric scales: Glabellar Lines Scale with contraction
0-No glabella lines
- Mild glabella lines
- Moderate glabella lines
- Severe glabella lines
- Very severe glabella lines
Measured: 0, 2, 4, 8, 12, 16, 20, 24 weeks
Changes of scores of Validated photonumeric scales: Crow Feet Scale at rest
0-No wrinkles
- Mild wrinkles
- Moderate wrinkles
- Severe wrinkles
- Very severe wrinkles
Measured: 0, 2, 4, 8, 12, 16, 20, 24 weeks
Changes of scores of Validated photonumeric scales: Crow Feet Scale with contraction
0-No wrinkles
- Mild wrinkles
- Moderate wrinkles
- Severe wrinkles
- Very severe wrinkles
Measured: 0, 2, 4, 8, 12, 16, 20, 24 weeks
Secondary outcomes (2)
Investigators Global Aesthetic Improvement Scale
- Very Much Improved: optimal cosmetic results
- Much Improved: marked improvement in appearance from initial condition but not completely optimal
- Improved: obvious improvement in appearance from initial condition but additional treatments are advised
- No Change: the appearance is the same as the original condition
- Worse: the appearance is worse from the original condition
Measured: 0, 2, 4, 8, 12, 16, 20, 24 weeks
Patient satisfaction
- Very Satisfied
- Satisfied
- Dissatisfied
- Very Dissatisfied.
Measured: 0, 2, 4, 8, 12, 16, 20, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 May 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Joseph University, Beirut, Lebanon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samer jabbour, St Joseph University, Beirut, Lebanon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836638
- Sponsor's protocol ID
- USJ-09
- Status last verified
- Feb 2019
- First submitted
- 24 Aug 2018
- Last updated
- 11 Feb 2019
- 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 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Age on Botulinum Toxin Potency in Facial Rhytides Treatment: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03836638
- Acronym / sponsor ID
- USJ-09
- Conditions
- Aging, Botulinum Toxin, Facial Wrinkles
- Keywords
- Botulinum Toxin, Rejuvenation, Age, Wrinkles, Rhytidis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- St Joseph University, Beirut, LebanonUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 11 Feb 2019 (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.
Botulinum toxin is approved by the FDA for the treatment of facial wrinkles. Patients are usually older than 45 years and their main demand is to treat pre-existing facial wrinkles. However with the increasing popularity of this technique, younger patients, aged 25 to 35 years, are now seeking botulinum toxin injection as a preventive measure for rhytides. The usual dose used for the treatment of facial rhytides in a female patient older than 45 years is 50 units. No consensus exists concerning the dose of botulinum toxin that should be used in younger patients. Hypothesis: lower dose of botulinum toxin is sufficient to give good and long lasting results in young patients. The objective of this randomized open-label study is to evaluate the effect of lower doses of Botulinum toxin on the facial rythides in young patients.
Detailed description
Botulinum toxin is approved by the FDA for the treatment of facial wrinkles. Patients are usually older than 45 years and their main demand is to treat pre-existing facial wrinkles. However with the increasing popularity of this technique, younger patients, aged 25 to 35 years, are now seeking botulinum toxin injection as a preventive measure for rhytides. The usual dose used for the treatment of facial rhytides in a female patient older than 45 years is 50 units. No consensus exists concerning the dose of botulinum toxin that should be used in younger patients. Hypothesis: lower dose of botulinum toxin is sufficient to give good and long lasting results in young patients.
The objective of this randomized open-label study is to evaluate the effect of lower doses of Botulinum toxin on the facial rythides in young patients.
In this trial, patients will be divided into 3 groups: Group 1 patients will be 25-35 years old and will be injected with 30 units of botulinum toxin into the upper face, group 2 patients will be older than 45 and will be injected with the same amount of botulinum toxin into the upper face and group 3 patients will be older than 45 and will be treated with the usual 50 units dose (control group). Patients older than 45 will be randomized between groups 2 and 3. Validated photonumeric scales will be used to evaluate the wrinkles at rest and with muscle contraction at 2, 4, 8, 12, 16, 20, 24 weeks post injection in the 3 groups. The patient satisfaction rate and the Physician global assessment will also be evaluated in the 3 groups. The scores will be determined by 3 independent blinded raters.
Hypothesis:
(1) the low dose will be sufficient to treat the group 1 patients and it will be insufficient to treat the group 2 patients. (2) The results will last longer in groups 1 and 3 patients compared to group 2 patients. (3) Group 1 patients treated with low doses of botulinum toxin will have similar results to the group 3 patients treated with the standard dose of botulinum toxin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose young subjects | Experimental | Drug: 30 Units of botulinum toxinGroup 1 patients will be 25-35 years old and will be injected with 30 units of botulinum toxin into the upper face |
| Low dose older subjects | Experimental | Drug: 30 Units of botulinum toxinGroup 2 patients will be older than 45 and will be injected with 30 units of botulinum toxin into the upper face |
| high dose older subjects | Active comparator | Drug: 50 Units of botulinum toxinGroup 3 patients will be older than 45 and will be treated with the usual 50 units dose into the upper face (control group) |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female patients presenting to our clinic for Facial wrinkle treatment with botulinum toxin
- Must be between 25-35 years old to be included in group 1.
- Must be older than 45 to be included in groups 2 and 3.
Key exclusion criteria (11 listed)
- Patients with previous periorbital/forehead surgery
- Patients who plucked the upper eyebrow margin
- Patients with eyebrow tatoos
- Patients with upper face botulinum toxin injection in the past 12 months
- Patients with resorbable upper face fillers injection in the past 12 months
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 |
|---|---|---|
| 30 Units of botulinum toxin30 Units of botulinum toxin to upper face | Drug | Low dose older subjects, Low dose young subjects |
| 50 Units of botulinum toxin50 Units of botulinum toxin to upper face | Drug | high dose older subjects |
Primary outcome
Changes of scores of Validated photonumeric scales: Brow Positioning Scale at rest
Time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
0-Youthful, refreshed look and high-arch eyebrow 1. Medium-arch eyebrow 2. Slight arch of the eyebrow 3. Flat arch of the eyebrow, visibility of folds, and tired appearance 4. Flat eyebrow with barely any arch, marked visibility of folds, and very tired appearance.
Changes of scores of Validated photonumeric scales: Forehead Lines Scale at rest
Time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
0-None 1. Minimal 2. Moderate 3. Deep 4. Extreme
Changes of scores of Validated photonumeric scales: Forehead Lines Scale with contraction
Time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
0-None 1. Minimal 2. Moderate 3. Deep 4. Extreme
Changes of scores of Validated photonumeric scales: Glabellar Lines Scale at rest
Time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
0-No glabella lines 1. Mild glabella lines 2. Moderate glabella lines 3. Severe glabella lines 4. Very severe glabella lines
Changes of scores of Validated photonumeric scales: Glabellar Lines Scale with contraction
Time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
0-No glabella lines 1. Mild glabella lines 2. Moderate glabella lines 3. Severe glabella lines 4. Very severe glabella lines
Changes of scores of Validated photonumeric scales: Crow Feet Scale at rest
Time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
0-No wrinkles 1. Mild wrinkles 2. Moderate wrinkles 3. Severe wrinkles 4. Very severe wrinkles
Changes of scores of Validated photonumeric scales: Crow Feet Scale with contraction
Time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
0-No wrinkles 1. Mild wrinkles 2. Moderate wrinkles 3. Severe wrinkles 4. Very severe wrinkles
2 secondary outcomes
Investigators Global Aesthetic Improvement Scale
Time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
Patient satisfaction
Time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30 Units of botulinum toxin and 50 Units of botulinum toxin in people with Aging and Botulinum Toxin, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
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 11 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 11 Feb 2019. 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 Lebanon. 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.
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?
Changes of scores of Validated photonumeric scales: Brow Positioning Scale at rest (time frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks). The study lists 7 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 11 Feb 2019.