NCT03836638

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: St Joseph University, Beirut, Lebanon · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	30 Units of botulinum toxin	30 Units of botulinum toxin to upper face
DRUG	50 Units of botulinum toxin	50 Units of botulinum toxin to upper face

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-02-11
• Last updated: 2019-02-11

Locations

1 site across 1 country: Lebanon