Facial lines, specifically glabellar (frown) lines and lateral canthal (crow’s feet) lines Skin and Connective Tissue Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. UK-registered aesthetic clinics that offer botulinum toxin treatments as part of their routine practice 2. Clinics with at least one licensed healthcare professional (HCP) qualified to prescribe and administer botulinum toxin treatments, including doctors, dentists, or nurse prescribers 3. The prescribing healthcare professional must have a minimum of 3 years’ experience in administering botulinum toxin for aesthetic indications 4. Clinics that have the necessary facilities to store botulinum toxin safely, including refrigeration at 2–8°C 5. Clinics that have appropriate treatment rooms and equipment for administering botulinum toxin safely, including access to emergency equipment 6. Clinics that agree to treat a minimum of 10 eligible patients using RelabotulinumtoxinA as part of routine clinical practice within the study period 7. Clinics and participating HCPs willing to complete all three study questionnaires (baseline, 1 and 6 months) 8. Clinics and HCPs willing to adhere to the study protocol and data confidentiality requirements 9. Clinics and HCPs who provide written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Clinics that do not routinely provide botulinum toxin treatments as part of their aesthetic practice 2. Clinics that do not have a prescriber on-site with appropriate qualifications to administer botulinum toxin (e.g., doctor, dentist, nurse prescriber) 3. Healthcare professionals (HCPs) with less than 3 years of experience administering botulinum toxin for aesthetic purposes 4. Clinics that lack appropriate storage facilities, such as a refrigerator capable of storing botulinum toxin at 2–8°C 5. Clinics that do not have appropriate treatment facilities and emergency equipment necessary for the safe administration of botulinum toxin 6. Clinics or healthcare professionals unable or unwilling to recruit 10 suitable patients for botulinum toxin treatment within the study timeframe 7. Healthcare professionals unwilling or unable to complete all three required study questionnaires (baseline, 1 and 6 months) 8. Clinics or healthcare professionals who refuse to comply with the study protocol, data confidentiality, and GDPR requirements 9. Clinics and healthcare professionals directly employed by Galderma UK Ltd, or otherwise involved in the design and oversight of the study, to avoid potential conflicts of interest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinician perception of RelabotulinumtoxinA as a convenient, ready-to-use neuromodulator with long-lasting efficacy in patients seeking aesthetic treatment. This is assessed through a single validated questionnaire item completed at baseline (prior to the first use of the product) and at 6 months following product adoption. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinician perception of the ease of use of RelabotulinumtoxinA, measured using a structured questionnaire at 1 and 6 months 2. Clinician perception of the potential for dosing errors or wastage when using RelabotulinumtoxinA, measured using a structured questionnaire at 1 and 6 months 3. Clinician perception of patient satisfaction with treatment outcomes (as observed in their practice), measured using a structured questionnaire at 1 and 6 months 4. Clinician perception of the need for treatment touch-ups or adjustments after initial injection, measured using a structured questionnaire at 1 and 6 months 5. Clinician perception of the financial impact of using RelabotulinumtoxinA on clinic operations (e.g., efficiency, cost-effectiveness, revenue), measured using a structured questionnaire at 1 and 6 months 6. Clinician perception of the impact of RelabotulinumtoxinA on clinic reputation and patient retention, measured using a structured questionnaire at 1 and 6 months 7. Clinician perception of sustainability and reduction in clinical waste associated with using a ready-to-use formulation, measured using a structured questionnaire at 1 and 6 months | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales