Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Galderma R&D
With
DeNova Research
Age
18–64
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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:
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
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
Clareo Health | A Controlled Study on Pain Management With Injection of Botulinum Toxin for Glabellar Line Correction
