Treatment and prevention of upper facial rhytdies including glabellar frown lines and crow’s feet. Skin and Connective Tissue Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Over the age of 21 years 2. Male or female 3. Identical twin; both twins must consent to participation in the study
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding 2. Previous treatment with permanent/non-biodegradeable products to the upper face area. I.e. lifting threads or fat transfer (lipofilling) 3. Significant trauma and/ or surgery to upper face including fracture of skull/facial bones 4. Significant scarring of upper face 5. Neuromuscular disorder of the upper face including significant nerve palsy 6. Prescribed anticoagulant or have a bleeding disorder 7. Current or previous psychiatric illness (e.g. Psychosis, depression, anxiety) that could affect safety during the study 8. Participating in another scientific study within 30 days of starting treatment 9. Twins must not be receiving any other neuromodulator treatment for the reduction of upper facial rhytdies for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessed annually up to 5 years: 1. Assessor reported outcomes: improvement in Global Aesthetic Improvement Scale (GAIS) ratings following repeated treatments with Alluzience® 2. Patient reported outcomes: improvement in Global Aesthetic Improvement Scale (GAIS) ratings following repeated treatments with Alluzience® | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of patients' emotional display, feelings about self, interpersonal communications and well-being (physical and psychological). This is undertaken via patient self-assessment questionnaires. Assessed annually up to 5 years. | — |
Countries
England, United Kingdom