Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Forehead Wrinkles; Forehead Rhytides

Treatments: Drug: 2.5% lidocaine/2.5% prilocaine; Device: petrolatum ointment; Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT03799484

HSC-MS-18-0908

Details and patient eligibility

About

The purpose of this study is to determine whether there is a difference in clinical effect, duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to Botulinum Toxin Type A administration for the treatment of forehead rhytides.

Full description

This is a prospective, randomized, double-masked, comparative study in patients who present at the Robert Cizik Eye Clinic with horizontal forehead rhytides requiring treatment with botulinum toxin Type A (Botox ®; Allergan, Irvine, CA, USA).

The objective of this study is to determine whether there is a difference in clinical effect (weakness/paralysis of the frontalis muscle), duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia (2.5% lidocaine/2.5 % prilocaine cream, Impax Laboratories, LLC) on one side of the forehead and petrolatum ointment on the other prior to BTX-A administration for the treatment of forehead rhytides.

• Primary outcome variable is change of eyebrow excursion on each side of the forehead from baseline to each follow-up visit.

• Secondary outcome variables

  • Duration of effect, defined as the elapsed time from injection to the end of botulinum, such that return of baseline frontalis function, i.e. within 2 mm of baseline value
  • Perception of pain immediately after injection at each side
  • Patient satisfaction for each side
  • Patient's perception of difference in efficacy

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 65 years of age
• Presence of horizontal forehead rhytides
• Good eyebrow excursion (greater than or equal to 5 mm)
• Able to understand and sign an informed consent form that has been approved by the Committee for the Protection of Human Subjects

Exclusion criteria

• Previous injection of botulinum toxin in the intended treatment area for the study within the last 4 months
• Known allergy to botulinum toxin
• Known history of sensitivity to local anesthetics of the amide type
• Existing disorder of neuromuscular transmission
• Usage of medication with effect on neuromuscular function
• Women of childbearing potential (who are not postmenopausal for at least 1 year or surgically sterile), who are pregnant or nursing or intend to become pregnant during the time of the study
• Significant brow asymmetry (> 5mm)
• Unable to follow-up for the duration of the study (16 weeks)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups

Topical Anesthesia

Other group

Description:

2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection

Treatment:

Drug: Botulinum toxin type A

Drug: 2.5% lidocaine/2.5% prilocaine

Petrolatum

Other group

Description:

Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection

Treatment:

Drug: Botulinum toxin type A

Device: petrolatum ointment