An Open-label, Randomized, Split-face, Controlled Study on Pain Management With Injection of Botulinum Toxin for Glabellar Line Correction

Galderma R&D1 site in 1 country60 target enrollmentOctober 23, 2023

ConditionsInjection Site Discomfort

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Injection Site Discomfort
Sponsor: Galderma R&D
Enrollment: 60
Locations: 1
Primary Endpoint: Visual Analogue Scale
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, single-center, randomized, split-face, controlled study to assess the effect of comfort intervention on pain during treatment injection compared against non-comfort intervention.

Registry

clinicaltrials.gov

Start Date

October 23, 2023

End Date

February 15, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Galderma R&D

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult subjects aged 18-65 years
•Females or males
•Having any Fitzpatrick skin types I-VI
•Any races and ethnicities
•Having any self-assessed pain tolerance, with a minimum of 5 subjects in each category (low, medium, and high pain tolerance)
•Subject with intent to undergo correction of the glabellar lines (frown lines between the eyebrows)
•Subject with moderate-to-severe glabellar lines as assessed by investigator using Glabellar Line Severity Scale (GLSS).
•Subject with no history of aesthetic injection, i.e., botulinum toxin, collagen, hyaluronic acid, calcium hydroxyapatite, poly L-lactic acid or permanent materials.
•Subject with healthy immune systems
•Subject willing to abstain from any other facial plastic surgical or cosmetic procedure(s) during the duration of the study.

Exclusion Criteria

•Pregnant, breastfeeding, or planning pregnancy during the course of the study, confirmed by UPT.
•Current smokers or consumer nicotine (e.g., cigarettes, e-cigarettes, vaping device with pre-filled pods, vapor tank or mod, chewing tobacco)
•History of allergy or hypersensitivity to botulinum toxin type A, human albumin, lactose, or cow's milk protein
•Subject with signs and symptoms of eyelid or brow ptosis, inability to substantially lessen glabellar lines by physically spreading them apart, or history or presence of facial nerve palsy, as judged by the Investigator.
•Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
•Previous aesthetic treatment in the face with any of the following injection prior to the baseline visit:
•Botulinum toxin
•Collagen, hyaluronic acid
•Calcium hydroxylapatite, poly L-lactic acid, fat or permanent materials (non-biodegradable)
•Previous treatment/procedure in the face in the previous 2-4 weeks that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study e.g.,

Outcomes

Primary Outcomes

Visual Analogue Scale

Time Frame: Baseline

Visual Analogue Scale is a 11-point psychometric scale that specifies the level of pain. Subject will be shown a photo of a VAS and verbally report a pain score between 0 and 10, which will be captured by a clinic staff. A score of 0 corresponds to no pain felt and a score of 10 corresponds to very high pain.