KCT0004952
Recruiting
未知
Investigations on the efficacy and safety of intradermal injection of botulinum toxin
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the skin and subcutaneous tissue
- Sponsor
- Samsung Medical Center
- Enrollment
- 23
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Healthy adult men and women in their 30s and 50s
- •2\) Those who can follow up during the clinical trial schedule (12 weeks)
- •3\) Those who have no serious abnormalities in pre\-examination or examination
- •4\) A person who understands the consent before conducting all test\-related evaluation / procedures, discloses the intention to participate in the clinical trial through himself or a legal representative, and signs the consent.
- •5\) Those who can and willing to comply with the schedule of visits and other clinical trial protocol requirements.
Exclusion Criteria
- •1\) Those with systemic neuromuscular junction disorder
- •(Example: myasthenia gravis, Eaton\-Lambert syndrome, amyotrophic lateral sclerosis, etc.)
- •2\) Those who have the following treatment skills or who have plans during the clinical trial period that are thought to influence the evaluation of this clinical trial before the screening visit.
- •\-Those who have undergone a permanent filler (silicone, fat grafting, tissue grafting, etc.) procedure that may affect wrinkle evaluation
- •\-Those who have undergone a semi\-permanent filler (CaHA (Calcium Hydroxyapatite), collagen\-stimulator, etc.) procedure within 1 year prior to participation in clinical research
- •\-Those who have undergone temporary filler (hyaluronic acid, etc.) treatment within 6 months of participation in clinical research
- •\-Those who have undergone cosmetic procedures (radio\-frequency treatment, HIFU, fractional laser, thread, chemical peeling over medium depth, etc.) on the face within 6 months of participation in clinical research
- •\-In the case of using cosmetics, external preparations, or oral drugs with wrinkle improvement function, there has been a change in use from 1 month prior to the screening time, or is expected to change during the clinical trial participation period even if they are used stably.
- •3\) People with facial asymmetry, skin relaxation, or deep scars on the face that interfere with wrinkles and texture evaluation, or those with excessively thick skin
- •4\) Those who are allergic to a drug for clinical trials or its components or have a history of hypersensitivity reactions
Outcomes
Primary Outcomes
Not specified
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