A Controlled Study on Pain Management With Injection of Botulinum Toxin for Glabellar Line Correction

NCT ID: NCT06161246

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-23
• Study Completion Date: 2024-02-15

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.

Conditions

Injection Site Discomfort

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Subjects will be treated for correction of glabellar lines with Dysport and comfort intervention on one side and Dysport only on the other side depending on pre-determined randomization. Subjects will complete the study assessments and end the study.

Group Type: EXPERIMENTAL

Vibrating Beauty Bar

Intervention Type: DEVICE

A vibrating beauty bar will be used at the injection site for patient comfort.

Interventions

Vibrating Beauty Bar

A vibrating beauty bar will be used at the injection site for patient comfort.

Intervention Type: DEVICE

Other Intervention Names

Vibration therapy

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.
• For female subjects of childbearing potential, she must not be pregnant, breastfeeding or planning pregnancy during the course of the study. Subjects must be willing to take a urine pregnancy test (UPT) prior to all treatment injections.
• Ability of giving consent for participation in the study
• Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments

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:

1. Botulinum toxin

2. Collagen, hyaluronic acid

3. 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.,

1. Resurfacing (laser, photo modulation, light, radiofrequency, ultrasound, chemical peel, dermabrasion, or other ablative/non-ablative procedures)

2. Needling or mesotherapy

3. Cryotherapy

• Presence of any disease or lesions near or on the glabellar region, e.g.,

1. Inflammation, active, or chronic infection in or near the treatment area

2. Psoriasis, eczema, rosacea, atopic dermatitis, herpes zoster/herpes simplex, and acanthosis

3. Scars or deformities

• History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation (e.g., aspirin or other non-steroidal anti-inflammatory drugs), omega 3, or vitamin E within 14 days before treatment. Omega 3 and vitamin E are acceptable only as part of a standard multivitamin formulation.
• Planning on having surgeries and/or invasive medical procedures during the course of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DeNova Research

OTHER

Sponsor Role: collaborator

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DeNova Research

Chicago, Illinois, United States

Countries

United States

Other Identifiers

GLI.04.US.SL.028

Identifier Type: -

Identifier Source: org_study_id