The Impact of Age on Botulinum Toxin Potency in Facial Rhytides Treatment

February 8, 2019 updated by: samer jabbour, St Joseph University, Beirut, Lebanon

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
    • Aschrafieh
      • Beirut, Aschrafieh, Lebanon, 00961
        • Hotel Dieu de France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Low dose young subjects
Group 1 patients will be 25-35 years old and will be injected with 30 units of botulinum toxin into the upper face
Drug: 30 Units of botulinum toxin
30 Units of botulinum toxin to upper face
EXPERIMENTAL: Low dose older subjects
Group 2 patients will be older than 45 and will be injected with 30 units of botulinum toxin into the upper face
Drug: 30 Units of botulinum toxin
30 Units of botulinum toxin to upper face
ACTIVE_COMPARATOR: high dose older subjects
Group 3 patients will be older than 45 and will be treated with the usual 50 units dose into the upper face (control group)
Drug: 50 Units of botulinum toxin
50 Units of botulinum toxin to upper face

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
0, 2, 4, 8, 12, 16, 20, 24 weeks
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
0, 2, 4, 8, 12, 16, 20, 24 weeks
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
0, 2, 4, 8, 12, 16, 20, 24 weeks
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
0, 2, 4, 8, 12, 16, 20, 24 weeks
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
0, 2, 4, 8, 12, 16, 20, 24 weeks
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
0, 2, 4, 8, 12, 16, 20, 24 weeks
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
0, 2, 4, 8, 12, 16, 20, 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Investigators Global Aesthetic Improvement Scale
Time Frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
  1. Very Much Improved: optimal cosmetic results
  2. Much Improved: marked improvement in appearance from initial condition but not completely optimal
  3. Improved: obvious improvement in appearance from initial condition but additional treatments are advised
  4. No Change: the appearance is the same as the original condition
  5. Worse: the appearance is worse from the original condition
0, 2, 4, 8, 12, 16, 20, 24 weeks
Patient satisfaction
Time Frame: 0, 2, 4, 8, 12, 16, 20, 24 weeks
  1. Very Satisfied
  2. Satisfied
  3. Dissatisfied
  4. Very Dissatisfied.
0, 2, 4, 8, 12, 16, 20, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St Joseph University, Beirut, Lebanon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • USJ-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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