None listed
Conditions
Interventions
Drug : In this study, the horizontal wrinkles on the forehead of a patient are divided into left and right sides based on the midline, randomly assigned, and the test group toxin will be administered
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adult males and females over 20 years of age 2. Those with horizontal forehead wrinkles 3. Patients with Facial Wrinkle Scale with photonumeric guide (FWS) moderate to severe (Investigator-assessed) 4. A person who can follow the procedures of clinical trials well and adhere to the visit schedule 5. Those who voluntarily sign the consent form
Exclusion criteria
Exclusion criteria: 1. Those who have had botulinum toxin injection experience within 1 year of screening 2. Patients who have undergone cosmetic procedures around the frontal lobe and orbit within 1 year of screening 3. Those with asymmetric horizontal forehead wrinkles 4. Those with scars around the frontal lobe or orbit 5. Those with infection or inflammation at the injection site 6. People with compensatory prefrontal hyperactivity 7. Persons with diseases that may affect neuromuscular function, such as myasthenia gravis, Eaton-Lamburton syndrome, amyotrophic lateral sclerosis, motor neuropathy, etc. 8. Those who have been diagnosed with or treated for fibromyalgia 9. Taking anticoagulants, aminoglycoside antibiotics, curare-like agents, or drugs that inhibit neuromuscular function (muscle relaxants, anticholinergics, benzodiazepines, benzamides, tetracyclines, lincomycin antibiotics, etc.) However, registration of muscle relaxants and benzodiazepines is possible if the dosage is stably maintained within 4 weeks or it is expected that there will be no change during the clinical trial period. 10. Those who are allergic to or sensitive to clinical investigational drugs or their ingredients 11. Those who are allergic to or sensitive to iodine 12. Women who are pregnant, lactating, or planning to become pregnant during the clinical period, or women of childbearing age who do not use available contraceptives (Women of childbearing age must have a negative pregnancy test before injection). 13. Those who are allergic to or sensitive to botulinum toxin 14. Those who participated in other clinical trials within 30 days before screening or those who have not passed the longer period of 5 times the half-life of the investigational drug in the clinical trial in which they participated. 15. Those who are not suitable for this clinical trial under the judgment of other investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area of anhidrosis evaluated by the minor iodine starch test after administration of the botulinum toxin | — |
Secondary
| Measure | Time frame |
|---|---|
| Area of wrinkle reduction evaluated by digital photographs in the resting state and maximal forehead wrinkle (forced upward gaze) after botulinum toxin administration.;Area of wrinkle reduction evaluated by 3D image device (Antera, morpheus system) in the resting state and maximal forehead wrinkle (forced upward gaze) after administration of botulinum toxin. | — |
Countries
Korea, Republic of
Contacts
Public ContactIn Soon Kwon
Yonsei University Health System, Severance Hospital
Outcome results
None listed