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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

45

Phase

  • 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

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
Intervention / Treatment
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

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

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

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)

May 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

August 24, 2018

First Submitted That Met QC Criteria

February 8, 2019

First Posted (ACTUAL)

February 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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