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Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

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ClinicalTrials.gov Identifier: NCT03799484
Recruitment Status : Enrolling by invitation
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
Robert Cizik Eye Clinic
Information provided by (Responsible Party):
Karina Richani-Reverol, The University of Texas Health Science Center, Houston

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Forehead Rhytides Forehead Wrinkles Drug: Botulinum toxin type A Drug: 2.5% lidocaine/2.5% prilocaine Device: petrolatum ointment Phase 4

Detailed 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Randomization will only be known by the principal investigator performing the injections and will not be disclosed to the participants or the brow excursion examiner.
Primary Purpose: Other
Official Title: Randomized, Single Center, Masked Study Comparing the Efficacy of Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
Estimated Study Start Date : January 2, 2019
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Topical Anesthesia
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
Drug: Botulinum toxin type A
Botulinum toxin type A will be administered to both sides
Other Name: BTX-A

Drug: 2.5% lidocaine/2.5% prilocaine
2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead
Other Name: EMLA

Petrolatum
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
Drug: Botulinum toxin type A
Botulinum toxin type A will be administered to both sides
Other Name: BTX-A

Device: petrolatum ointment
petrolatum ointment will be applied to one side of the forehead
Other Name: Aquaphor




Primary Outcome Measures :
  1. Change in eyebrow excursion [ Time Frame: Baseline, Week 2 ]
    Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.

  2. Change in eyebrow excursion [ Time Frame: Baseline, Week 6 ]
    Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.

  3. Change in eyebrow excursion [ Time Frame: Baseline, Week 16 ]
    Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.


Secondary Outcome Measures :
  1. Number of participants for whom Botulinum Toxin Type A effect lasted at least 2 weeks [ Time Frame: Week 2 ]
    Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value.

  2. Number of participants for whom Botulinum Toxin Type A effect lasted at least 6 weeks [ Time Frame: Week 6 ]
    Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value.

  3. Number of participants for whom Botulinum Toxin Type A effect lasted at least 16 weeks [ Time Frame: Week 16 ]
    loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value.

  4. Perception of pain immediately after injection as assessed by a visual analogue scale [ Time Frame: Immediately after botox injection ]
    A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome.

  5. Participant satisfaction [ Time Frame: Week 2 ]
    Participant satisfaction will be assessed by a survey that includes questions about the overall appearance of the forehead. The survey will be assessed using a 5-point rating scale: 5 = very satisfied, 4 = satisfied, 3 = neutral, 2 = dissatisfied and 1 = very dissatisfied. Higher scores indicate a better outcome. The survey has 3 satisfaction questions. Average scores ranging from 3 (very dissatisfied) to 15 (very satisfied).

  6. Participant satisfaction [ Time Frame: Week 6 ]
    Participant satisfaction will be assessed by a survey that includes questions about the overall appearance of the forehead. The survey will be assessed using a 5-point rating scale: 5 = very satisfied, 4 = satisfied, 3 = neutral, 2 = dissatisfied and 1 = very dissatisfied. Higher scores indicate a better outcome. The survey has 3 satisfaction questions. Average scores ranging from 3 (very dissatisfied) to 15 (very satisfied).

  7. Participant satisfaction [ Time Frame: Week 16 ]
    Participant satisfaction will be assessed by a survey that includes questions about the overall appearance of the forehead. The survey will be assessed using a 5-point rating scale: 5 = very satisfied, 4 = satisfied, 3 = neutral, 2 = dissatisfied and 1 = very dissatisfied. Higher scores indicate a better outcome. The survey has 3 satisfaction questions. Average scores ranging from 3 (very dissatisfied) to 15 (very satisfied).

  8. Number of participants who perceive a difference in efficacy [ Time Frame: Week 2 ]
    Participants will be asked if there is a noticeable difference between the 2 sides of their face.

  9. Number of participants who perceive a difference in efficacy [ Time Frame: Week 6 ]
    Participants will be asked if there is a noticeable difference between the 2 sides of their face.

  10. Number of participants who perceive a difference in efficacy [ Time Frame: Week 16 ]
    Participants will be asked if there is a noticeable difference between the 2 sides of their face.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799484


Locations
United States, Texas
Robert Cizik Eye Clinic
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Robert Cizik Eye Clinic
Investigators
Principal Investigator: Karina Richani-Reverol, MD The University of Texas Health Science Center, Houston

Publications:

Responsible Party: Karina Richani-Reverol, Clinical Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03799484     History of Changes
Other Study ID Numbers: HSC-MS-18-0908
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Karina Richani-Reverol, The University of Texas Health Science Center, Houston:
Rhytides
Forehead Wrinkles

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Prilocaine
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Petrolatum
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Acetylcholine Release Inhibitors
Cholinergic Agents
Neurotransmitter Agents
Neuromuscular Agents
Emollients
Dermatologic Agents