Clinical trial NCT06161246: A Controlled Study on Pain Management With Injection of Botulinum Toxin for Glabellar Line Correction
Official title: An Open-label, Randomized, Split-face, Controlled Study on Pain Management With Injection of Botulinum Toxin for Glabellar Line Correction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Injection Site Discomfort
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
Collaborators: name: DeNova Research
First posted: 2023-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will receive comfort intervention on one side of face, and will not receive comfort intervention on the other side of face.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Baseline
Secondary outcomes:
measure: Self-assessment questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
References: