Satisfaction study of split doses botulinum toxin with double frequency
- Conditions
- cosmetic treatmentrhytidewrinkle
- Registration Number
- NL-OMON49792
- Lead Sponsor
- Flack Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 96
· 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.
· 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Satisfaction Scale - score of treatment satisfaction over time compared with<br /><br>base-line. </p><br>
- Secondary Outcome Measures
Name Time Method