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Novel Technique for Botulinum Toxin Injection to Minimize Patient Discomfort

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Henry Ford Health

Status

Completed

Conditions

Pain

Treatments

Drug: botulinum type a

Study type

Interventional

Funder types

Other

Identifiers

NCT00628472
IRB 4300

Details and patient eligibility

About

This single blinded randomized pilot study was performed on 21 Caucasian females to determine if injections through follicular openings were less painful than traditional injections for cosmetic botulinum toxin type A injections.

Full description

Objective: To investigate whether injection of botulinum toxin type A is less painful if performed through follicular openings versus traditional non-specific approach.

Design: Prospective, randomized, single-blinded study.

Setting: Academic dermatology department.

Patients: A volunteer sample of twenty female patients aged 25-55 who had no prior history of botulinum toxin injection.

Intervention: Each patient received six randomized injections of botulinum toxin type A (Botox® Allergan). Two injections into the procerus muscle and two into each corrugator muscle. Three of the injections were performed through follicular openings and three were performed traditionally.

Main Outcome Measure: Patient discomfort on a 1-10 scale and direct comparison between the two injection techniques.

Enrollment

21 patients

Sex

Female

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Female
  • No prior history of botulinum toxin
  • Age 25-55

Exclusion criteria

  • Male
  • Prior history of botulinum toxin
  • Neuromuscular disorders
  • Aminoglycoside therapy

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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