Satisfaction study of split doses botulinum toxin with double frequency

Satisfaction study of split doses botulinum toxin with double frequency - Split dose double frequency study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49792

Enrollment

Registered

2019-01-09

Start date

2020-12-01

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cosmetic treatment rhytide wrinkle

Interventions

Clients will be randomized in a 1:1 ratio into the intervention group (IG) or control group (CG). The IG will be treated with half of the standard dose (Table 1 of protocol) of NT201 at every visit.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: · Males or females, 18 to 65 years of age, inclusive; · General good health status · Symmetrical rhytids on both sides of the face, expressed by a Merz Aesthetics Scales score in dynamic >= 2 in all treatment areas; · Client overall satisfaction score >= 2 and

Exclusion criteria

Exclusion criteria: · Clients with known allergies or sensitivity to the drug or any components of the study medication; · Use of any agent that impedes the neuromuscular transmission, or other neuromus-cular diseases that could amplify the effects of botulinum toxin type A treatment (e.g. myasthenia gravis, excessive weakness, Eaton-Lambert syndrome, or atrophy of target muscles); · Previous exposure to botulinum toxin

Design outcomes

Primary

Measure	Time frame
- Satisfaction Scale - score of treatment satisfaction over time compared with base-line.	—

Secondary

Measure	Time frame
- Satisfaction Scale - score of treatment satisfaction before Treatment 3 (after 4 months), and at the Follow-up visit (after 8 months); - Satisfaction Scale - difference in satisfaction score between the IG and CG for each time point; - Merz Aesthetics Scales in dynamic - at least one-point improvement on the Merz Aesthetic Scales in each of the treatment areas; - GAIS - score of at least improved; - Antera 3D camera - Wrinkle depth quantification (mm); - Canfield Vectra H2 - Wrinkle depth quantification (mm); - MoistureMeter SC Compact - quantification of increase in hydration compared to baseline in the stratum corneum of the dermis (arbitrary units) compared with baseline; - ElastiMeter - quantification of increase in elasticity (instant skin elasticity [N/m]) compared with baseline; - VapoMeter - quantification of decrease in TEWL (evaporation rate value [g/m²h]) compared with baseline; - SebumScale - quantification of decrease in sebum production (amount of sebum [mg/cm²]) compared with baseline; - BeautyQoL - change in score on QoL.	—

Measure

Time frame

- Satisfaction Scale - score of treatment satisfaction before Treatment 3 (after 4 months), and at the Follow-up visit (after 8 months); - Satisfaction Scale - difference in satisfaction score between the IG and CG for each time point; - Merz Aesthetics Scales in dynamic - at least one-point improvement on the Merz Aesthetic Scales in each of the treatment areas; - GAIS - score of at least *improved*; - Antera 3D camera - Wrinkle depth quantification (mm); - Canfield Vectra H2 - Wrinkle depth quantification (mm); - MoistureMeter SC Compact - quantification of increase in hydration compared to baseline in the stratum corneum of the dermis (arbitrary units) compared with baseline; - ElastiMeter - quantification of increase in elasticity (instant skin elasticity [N/m]) compared with baseline; - VapoMeter - quantification of decrease in TEWL (evaporation rate value [g/m²h]) compared with baseline; - SebumScale - quantification of decrease in sebum production (amount of sebum [mg/cm²]) compared with baseline; - BeautyQoL - change in score on QoL.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)