This study has been transitioned to CTIS with ID 2025-520915-14-00 check the CTIS register for the current data. Primary objectiveTo investigate the client*s satisfaction over time for the treatment of glabellar frown lines (GFL), horizontal…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cosmetic treatment
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Satisfaction Scale - score of treatment satisfaction over time compared with
base-line.
Secondary outcome
- 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.
Background summary
The field of aesthetic medicine focuses to minimizing signs of aging such as
skin laxity, wrinkles, and improve overall appearance. Treatments aims to
improve the perceived health and well-being of the client. For more than 20
years, botulinum toxin has been known for its applicability in aesthetic
practice.Through its property to induce muscle relaxation, the toxin is
approved by the EMA for the treatment of hyperactive facial lines, including
glabellar lines and horizontal forehead lines and crow*s feet.
The aim of this study is to evaluate the satisfaction of the client and
physician, as well as the pharmacodymanics of NT201 in two dosing regimens: the
standard regimen (control group) and a regimen with half the dose and a higher
injection frequency (intervention group).
Study objective
This study has been transitioned to CTIS with ID 2025-520915-14-00 check the CTIS register for the current data.
Primary objective
To investigate the client*s satisfaction over time for the treatment of
glabellar frown lines (GFL), horizontal forehead lines (HFL) and lateral
periorbital wrinkles, with half the stand-ard dose of NT201 administered at
more frequent intervals (intervention group; 2 months interval) and the
standard dose (control group; 4 months interval) measured with an elec-tronic
visual analogue scale (eVAS).
Secondary objective
· To evaluate the client*s satisfaction 4 and 8 months after baseline compared
with baseline for each of the treatment areas.
· To compared the differences in client satisfaction of the intervention group
com-pared with the control group during each visit for each of the different
treatment ar-eas.
· To evaluate improvement of the appearance at every study visit, using the
Global Aesthetic Improvement Scale (GAIS).
· To evaluate the wrinkle reduction using the Miravex Antera 3D imager, the
Canfield Vectra H2 3D camera, and the respective Merz Aesthetics Scales.
· To evaluate the changes in hydration, elasticity, transepidermal water loss
and se-bum production in the treated areas.
· To evaluate the impact on quality of life of clients in the intervention
group and con-trol group.
Study design
This will be a double-blind, randomized controlled study.
Intervention
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. The CG will be injected with
the standard dose (Table 1 of protocol) of NT201 every 4 months (1st and 3rd
treatment). To ensure blinding, clients in the CG will be treated with a
placebo during treatment 2 and 4.
An overview of the dosages can be found in table 1 of the protocol (page 13).
Study burden and risks
Seeking for beauty, many of the clients address to the aesthetic physician
requesting a natural result, a fresher look, and a well-rested appearance.
Therefore, the treatment with NT201 has a major role by reducing muscle
contraction in the treated area. By following the standard protocols and doses
of the injection techniques, subjects have also noticed, especially in the
first weeks after treatment, that the inability to use mimic muscles may lead
to an artificial, frozen appearance. By reducing the dose and increasing the
frequency of botulinum toxin injection, this study attempts to increase cliient
satisfaction by establishing a more natural appearance right from the debut of
the toxin's effect. Because of a split-face study design, asymmetry due to
different doses of NT201 might occur. Clients may withdraw from the study at
any time. A corrective treatment will be offered, without additional costs.
The potential risks of the procedures are minimal and they are related to the
injection techniques or allergic reactions. Considering that the physicians in
charge are members of the Dutch Society of Aesthetic Medicine (NVCG), who have
followed an extensive training program and have an extensive experience, the
risks will be even lower.
Falckstraat 51
Amsterdam 1017VV
NL
Falckstraat 51
Amsterdam 1017VV
NL
Listed location countries
Age
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 <= 8 based on the eVAS Satisfaction
Scale (0-10);
· Able to participate and willing to give informed consent and comply with the
study re-strictions.
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 < 6 months before the first treatment;
· Has ever received a permanent filler in the upper face, or has received a
temporary filler in the upper face in the last two years;
· Presence of an infection, or any type of skin disease, in the treatment area;
· Presence or history of a malignancy like melanoma in the treated area;
· Grade 4 lines in one re more of the treatment areas expressed by the Merz
Aesthetic Scales;
· Marked asymmetry of the crow*s feet by 1 point on the Merz Aesthetic Scales;
· Females who are pregnant, planning to get pregnant during the full duration
of the study, or breastfeeding.
· Clients with body dysmorphic disorder or related diagnosis in the DSM-V.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2025-520915-14-00 |
| EudraCT | EUCTR2017-004278-32-NL |
| CCMO | NL68226.018.18 |