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

NCT03836638 | Unknown

• 1 other identifier: USJ-09
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Aging; Botulinum Toxin; Facial Wrinkles

Keywords

Botulinum Toxin; Rejuvenation; Age; Wrinkles; Rhytidis

Outcome Measures

Primary Outcomes (7)

• Changes of scores of Validated photonumeric scales: Brow Positioning Scale at rest

  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

  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

  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

  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

  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

  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

  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 Outcomes (2)

• Investigators Global Aesthetic Improvement Scale

  0, 2, 4, 8, 12, 16, 20, 24 weeks

• Patient satisfaction

  0, 2, 4, 8, 12, 16, 20, 24 weeks

Study Arms (3)

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

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

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)

Drug: 50 Units of botulinum toxin

Interventions

30 Units of botulinum toxin DRUG

30 Units of botulinum toxin to upper face

Low dose older subjects; Low dose young subjects

50 Units of botulinum toxin DRUG

50 Units of botulinum toxin to upper face

high dose older subjects

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St Joseph University, Beirut, Lebanon: lead

Study Sites (1)

Hotel Dieu De France

Beirut, Aschrafieh, 00961, Lebanon

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: February 11, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 11, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)