A study exploring healthcare professionals' experiences using a ready-to-use botulinum toxin for cosmetic treatments in UK aesthetic clinics
| ISRCTN | ISRCTN30554575 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30554575 |
| IRAS number | 355065 |
- Submission date
- 12/03/2025
- Registration date
- 10/04/2025
- Last edited
- 10/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Botulinum toxin is commonly used in aesthetic medicine to reduce the appearance of facial lines such as frown lines and crow’s feet. A new formulation, called RelabotulinumtoxinA, has been developed that comes ready-to-use, without the need for reconstitution before injection. This may offer advantages in terms of time savings, reduced waste, and consistency of results. The PURE-QUEST study aims to understand how UK healthcare professionals working in aesthetic clinics experience using this product in real-world practice. It will also assess the broader clinical, operational, and financial impact of adopting the ready-to-use formulation, to support future decisions in aesthetic practice and inform a pharmacoeconomic model.
Who can participate?
Healthcare professionals (such as doctors, dentists, or nurse prescribers) working in UK aesthetic clinics who have at least three years of experience administering botulinum toxin treatments. Patients receiving treatment at these clinics will not be enrolled in the study, and no patient-identifiable data will be collected.
What does the study involve?
Clinics taking part will be provided with 10 vials of RelabotulinumtoxinA to use in the normal course of their practice. Participating clinicians will complete three questionnaires: one before they begin using the product, one after one month, and one at six months. The questionnaires ask about their experience using the product, including ease of use, impact on workflow, patient satisfaction (as observed by the clinician), and financial or operational considerations. No extra procedures or clinic visits are required for patients, and data will be anonymised.
What are the possible benefits and risks of participating?
There are no direct risks to clinicians participating in the study. Clinics benefit from the opportunity to evaluate a new botulinum toxin formulation in routine practice and contribute to research that may influence future guidance in aesthetic medicine. Patients are not involved as study participants and receive standard treatment as part of normal care.
Where is the study run from?
The study is sponsored by Galderma UK Ltd and run in collaboration with Medialis Ltd, and will involve 30 private aesthetic clinics across the UK, including England, Wales, Scotland and Northern Ireland.
When is the study starting and how long is it expected to run for?
September 2024 to March 2026
Who is funding the study?
Galderma UK Ltd
Who is the main contact?
Dr. Wojciech Konczalik, wojciech.konczalik@galderma.com
Contact information
Public, Scientific, Principal Investigator
Evergreen House North
Grafton Place
London
NW1 2DX
United Kingdom
| Phone | +44 (0)7917650496 |
|---|---|
| wojciech.konczalik@galderma.com |
Study information
| Study design | Observational questionnaire-based study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Questionnaire-based study |
| Study setting(s) | Other |
| Study type | Other |
| Scientific title | PURE-QUEST: preliminary UK RelabotulinumtoxinA experience – a questionnaire-based observational real-world study evaluating clinician experiences with a ready-to-use botulinum toxin (RelabotulinumtoxinA) in aesthetic practice |
| Study acronym | PURE-QUEST |
| Study hypothesis | This study is being conducted to gather real-world insights from healthcare professionals on the use of RelabotulinumtoxinA, a new ready-to-use botulinum toxin, in routine aesthetic practice. It aims to evaluate the product’s ease of use, impact on clinic workflow, and clinician perceptions of patient outcomes, while also exploring its pharmacoeconomic implications for aesthetic clinics. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | The Health Research Authority reviewed the manuscript on IRAS and agreed that the study constitutes post-marketing surveillance with no direct engagement of patients and therefore does not require REC approval |
| Condition | Facial lines, specifically glabellar (frown) lines and lateral canthal (crow’s feet) lines |
| Intervention | The study will recruit healthcare professionals from UK aesthetic clinics who will use RelabotulinumtoxinA as part of their routine practice to treat patients seeking botulinum toxin for facial lines. Participating clinicians will complete structured questionnaires at baseline, 1 and 6 months to capture their experiences with the product, including ease of use, patient satisfaction, and clinic workflow impact. Data will be anonymised and analysed descriptively to provide real-world insights and explore the pharmacoeconomic implications of the product. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/09/2024 |
| Overall study end date | 15/03/2026 |
Eligibility
| Participant type(s) | Health professional, Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/05/2025 |
| Recruitment end date | 01/07/2025 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centre
United Kingdom
Sponsor information
Industry
Evergreen House North
Grafton Place
London
NW1 2DX
England
United Kingdom
| Phone | +44 (0)7827251766 |
|---|---|
| medinfo.uk@galderma.com | |
| Website | https://www.galderma.com/uk/contact-us |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. |
Editorial Notes
10/04/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
