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

Aging Clinical Trial

Official title:

The Impact of Age on Botulinum Toxin Potency in Facial Rhytides Treatment: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03836638
• Other study ID #: USJ-09
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2019
• Source: St Joseph University, Beirut, Lebanon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Botulinum Toxin
• Facial Wrinkles
• Facies

Intervention

Drug:
• 30 Units of botulinum toxin
30 Units of botulinum toxin to upper face
• 50 Units of botulinum toxin
50 Units of botulinum toxin to upper face

Locations

Country	Name	City	State
Lebanon	Hotel Dieu De France	Beirut	Aschrafieh

Sponsors (1)

Lead Sponsor	Collaborator
St Joseph University, Beirut, Lebanon

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0, 2, 4, 8, 12, 16, 20, 24 weeks
Primary	Changes of scores of Validated photonumeric scales: Forehead Lines Scale at rest	0-None; Minimal; Moderate; Deep; Extreme	0, 2, 4, 8, 12, 16, 20, 24 weeks
Primary	Changes of scores of Validated photonumeric scales: Forehead Lines Scale with contraction	0-None; Minimal; Moderate; Deep; Extreme	0, 2, 4, 8, 12, 16, 20, 24 weeks
Primary	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	0, 2, 4, 8, 12, 16, 20, 24 weeks
Primary	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	0, 2, 4, 8, 12, 16, 20, 24 weeks
Primary	Changes of scores of Validated photonumeric scales: Crow Feet Scale at rest	0-No wrinkles; Mild wrinkles; Moderate wrinkles; Severe wrinkles; Very severe wrinkles	0, 2, 4, 8, 12, 16, 20, 24 weeks
Primary	Changes of scores of Validated photonumeric scales: Crow Feet Scale with contraction	0-No wrinkles; Mild wrinkles; Moderate wrinkles; Severe wrinkles; Very severe wrinkles	0, 2, 4, 8, 12, 16, 20, 24 weeks
Secondary	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	0, 2, 4, 8, 12, 16, 20, 24 weeks
Secondary	Patient satisfaction	Very Satisfied; Satisfied; Dissatisfied; Very Dissatisfied.	0, 2, 4, 8, 12, 16, 20, 24 weeks