Status and phase
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About
This clinical trial is an extended clinical trial for test subjects who participated in the phase 3 clinical trial of PT_BTA_P3_21 (clinical trial plan number) and completed follow-up observation up to 16 weeks after administration of clinical trial drugs, and evaluates the effectiveness and safety of repeated administration of protoxin in those with moderate or severe brow wrinkles.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
A person who has or is accompanied by the following diseases at the time of screening
A person who has wrinkles to the extent that the glabellar lines cannot be physically flattened, such as when wrinkles are not straightened by hand
A person who is taking the following drugs
A person who has had procedure/surgery that may affect the wrinkles around the glabellar or forehead during the following period
A person with a history of surgery or treatment around the orbit (except for double eyelid surgery, epicanthal fold (Mongolian fold) correction)
A person who is planning to undergo facial cosmetic procedures such as dermal filler, photorejuvenation, chemical peeling, and dermabrasionduring the clinical trial period
PT_BTA_P3_21 (Clinical Trial Plan Number) A person who received similar drugs for clinical trials such as botulinum toxin A and B after visiting the end of phase 3 clinical trials)
A person who is expected to administer botulinum toxin formulations other than this investigational product during the clinical trial period
A person with a history of hypersensitivity or allergy to the components of the investigational product (botulinum toxin formulations and serum albumin, etc.)
A person with a history of alcohol or drug addiction
A person who, in the investigator's judgment, may affect clinical trial participation or objective efficacy evaluation results, due to anxiety disorders or other significant psychiatric disorders (e.g., severe depression)
Women and men of childbearing potential who plan to become pregnant or do not intend to use appropriate contraceptive methods* during the clinical trial period
* Appropriate contraceptive methods
Pregnant or lactating women
A person with serious comorbidities (e.g., malignant tumors, immunodeficiency (decreased immune function), renal disease, liver disease, heart disease, respiratory disease, etc.) or acute diseases that are unsuitable for participation in the clinical trial as judged by the investigator
A person who participated in other clinical trials/clinical device trials within 30 days prior to screening and received administration/treatment of investigational products/devices, or a person for whom the longer period has not passed between the above period and 5 times the half-life of the investigational product in the clinical trial in which they participated
Others who are judged inappropriate to participate in this clinical trial by the investigator
Primary purpose
Allocation
Interventional model
Masking
155 participants in 1 patient group
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Central trial contact
Jinhong Park, Director; Hyunkyu Lee, Manager
Data sourced from clinicaltrials.gov
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