low dose high frequency
Satisfaction study of split doses botulinum toxin with higher frequency
low dose high frequency
The aim of this study is to compare the satisfaction, duration of effect and efficacy of the treatment with clients treated with half of the standard dose of NT201 more frequently (2 months) than in the client group treated with the standard dose every 4 months for glabellar frown lines (GFL), horizontal forehead lines (HFL) and lateral peri orbital lines (crow’s feet-CF)
Many clients have the desire for a natural look, being more satisfied with small changes in their appearance.
The objective of this study is to compare the satisfaction, duration of effect and efficacy of the treatment with clients treated with half of the standard dose of NT201 more frequently (2 months) than in the client group treated with the standard dose every 4 months for glabellar frown lines (GFL), horizontal forehead lines (HFL) and lateral peri orbital lines (crow’s feet-CF)
After randomization, both groups will receive fout NT201/placebo treatments every two months. The intervention group will receive half of the standard dose during treatment 1 - 4. The control group will be treated with the standard dose administered during treatment 1 and 3 (at baseline and after 4 months). To ensure blinding placebo solution will be injected during treatments 2 and 4 (after 2 months and after 6 months).
main study parameters/endpoints
Looking to improve the appearance of clients in a more natural way, the assessment will be based on both the subjective opinion of clients using the eVAS Satisfaction Scale and the BeautyQoL and the objective opinion of the physician using The Global Aesthetic Improvement Scale (GAIS), the Merz Aesthetic Scales for the respective areas at maximum contraction and measuring the depth of wrinkles by using Antera 3D and Canfield Vectra H2 camera. Another parameter is to evaluate the elasticity and the hydration of the skin in the study areas by using the Delfin Technologies devices, ElastiMeter and MoistureMeterSC.
The sebum production will be assessed using SebuScale and the transepidermal water loss through VapoMeter. The main endpoint of the study is to evaluate the increase in and stability of the satisfaction over time using the eVAS Satisfaction Scale compared to baseline. The other endpoints of the study are to reach ‘improved’ on the GAIS, also in the mentioned Merz Aesthetics Scales by at least one-point improvement on de MAS in each of the treatment areas, a reduction in the depth of the wrinkles measured with the Antera 3D and Vectra H2 cameras, and an improvement in the skin elasticity and hydration in the treated areas. Intervention and control groups will be compared.
The change from baseline in satisfaction, by using the eVAS Satisfaction Scale, is expected to be higher at follow-up (2 months after the last treatment) in the intervention group as compared to the control group.
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