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

NCT03836638 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-02-11

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • St Joseph University, Beirut, Lebanon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03836638 on ClinicalTrials.gov