None listed
Conditions
Interventions
Drug : Arm 1. 100 Unit of Botulax Inj.®(Botulinum toxin type A, Hugel, South Korea) was diluted with 10cc of saline and injected at multiple points around the subcutaneous layer of sutured site with
Sponsors
Hallym University Medical Center-Kangnam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female, whose ages are over 20 and below 65 2) Patients with forehead lacerations and treated with primary closure 3) Patients who can adhere to the follow up schedule and protocols of the clinical trial 4) Patients who voluntarily consented to the agreement form
Exclusion criteria
Exclusion criteria: 1) ongoing infection on forehead, systematic skin disorder 2) prior medical procedures on forehead in past 6 months from the recruitment 3) drug history of aspirin or other anticoagulants 4) presence of facial palsy or blepharoptosi 5) presence of neuromuscular junction disorders such as myasthenia gravis, Lambert-Eaton myasthenic syndrome 6) drug addiction or abuse, diagnosed mood disorder 7) presence of severe cardiovascular, renal, hepatic respiratory, or hematologic diseases 8) History of administration of similar drugs within 3 months prior to the screening 9) History of administration of drugs which have muscle relaxing effects such as muscle relaxants, Spectinomycin HCL injection, Aminoglycosides, polypeptide antibiotics, tetracyclines, lincosamides, anticholinergics, benzodiazepines, benzamide derivatives 10) Hypersensitivity to botulinum toxin A and other ingredients included in the preparation 11) Pregnant women and breastfeeding women 12) Women in their childbearing ages who are planning pregnancy within next 3 months or having unprotexted sex 13) Patients who participated in other cilincal trials within 30 days prior to screening or have not passed the 5 times of half-life of the administered drug from prior clinical trials 14) Acute systemic diseases 15) Other conditions which may lead to exclusion from the trial judged by researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analog scale score of scar;Patient and Observer Scar Assessment score of scar;Stony Brook Scar Evaluation Scale score of scar | — |
Secondary
| Measure | Time frame |
|---|---|
| Saftey evaluation (abnormal reaction, vital sign) | — |
Countries
Korea, Republic of
Contacts
Public ContactJun Won Lee
Hallym University Medical Center-Kangnam
Outcome results
None listed