crow'
Conditions
Interventions
Letibotulinum toxin A mixed in preservative-free normal saline solution is stored in a zip-lock plastic bag and kept refrigerated at 2-8 degrees Celsius for 1 month, 6-12 units injected into to random
s feet line. Dosage depends on wrinkles severity, but the dosage per side between experimental and control side are equal.
,Letibotulinum toxin A reconstituted in preservative-free normal saline solut
s feet line. Dosage depends on wrinkles severity, but the dosage per side between experimental and control side are equal.
Experimental Drug,Active Comparator Drug
Letibotulinum toxin A reconstituted in preservative-free normal saline solution is stored in a zip-lock plastic bag and kept refrigerated at 2-8 degrees Celsius for 1 month.,Freshly reconstituted Leti
Sponsors
none
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Must be 18 years old or above. 2. Must be healthy without serious chronic illnesses. 3. Must have crow's feet wrinkles as assessed clinically using the Flynn Validated Assessment Scale for the Upper Face, which is a 5-point photonumerical rating scale detailed in the table below. Participants with a score of 2 or higher will be eligible to participate in the study.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Presence of infection or inflammation on the facial skin or other skin conditions in the treatment area. 2. History of allergy to botulinum toxin or human albumin, or cow's milk. 3. Previous injections of botulinum toxin or fillers in the scalp, face, or any other procedures that assist in reducing facial wrinkles within the past 1 year prior to study participation. 4. Presence of wounds in the treatment area. 5. Permanent false eyelashes that cannot be removed. 6. History of neuromuscular diseases such as myasthenia gravis, amyotrophic lateral sclerosis. 7. Refusal or request to withdraw from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy and safety of both preparations 1, 2, 4, 8, 12, 16, and 24 weeks after treatment Indentation index from Antera 3D camera, patient satisfaction (GAIS), Pain score Adverse effects Microbiological testing | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of action of both preparations 1, 2, 4, 8, 12, 16, and 24 weeks after treatment Indentation index from Antera 3D camera, patient satisfaction (GAIS) | — |
Countries
Thailand
Contacts
Public ContactWaritta Dararattanaroj
Mahidol university
Outcome results
None listed