Enlarged pore size on both sides of anterior cheek Microneedle Microneedle patch Botulinum Toxins Type A Facial Pores Drug Delivery Systems Minimally Invasive Procedures
Conditions
Interventions
Intervention Details:
Dose: Botulinum toxin type A 10 units per side and delivered of Botulimun toxin type A by double-length microneedle patch
Intervention
1. Preparation of Microneedle Patch
Two ty
Microneedle patch delivered Botulinum toxin type A,Intradermal injection of Botulinum toxin type A
Sponsors
Merz Healthcare Company Limited, Thailand
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Thai participants aged 20 - 60 years 2. Participants with visible facial pores on both sides of anterior cheek (visible pores size 0.1 to 0.6 mm2)
Exclusion criteria
Exclusion criteria: 1. Participants who had history of allergy to botulinum toxin. 2. Participants who had history of allergy or hypersensitivity to polymethylmethacrylate (PMMA) and the monomer plastic. 3.Participants who had received topical retinoids within 1 month prior to the study. 4.Participants who had received oral retinoids within 3 months prior to the study. 5.Participants who had history of chemical peel within 3 months prior to the study. 6.Participants who had history of lasers resurfacing or energy-based devices treatment on both cheeks within 6 months prior to the study. 7.Participants who had history of filler or biostimulator injection on both cheeks within 1 year prior to the study. 8.Participants who had received botulinum toxin injection on both cheeks in the previous 6 months. 9.Participants who had severe underlying or uncontrolled diseases such as autoimmune connective tissue diseases 10. Participants who had history of neurological disease or coagulopathy. 11. Participants who had skin infection or active acne or eczematous dermatitis in the treated area. 12. Participants who use immunosuppressive therapy. 13. Pregnant or lactation 14. Participants who had facial scarat both cheek area.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pore volume at baseline, 1month, 3 month, and 6 month Antera 3D,Pore score at baseline, 1month, 3 month, and 6 month Visual grading | — |
Secondary
| Measure | Time frame |
|---|---|
| Subum production at baseline, 1month, 3 month, and 6 month Sebumeter,Skin roughness at baseline, 1month, 3 month, and 6 month Antera 3D,Pain score at day 0 (after intervention) Visual Analog Scale,Patient Satisfaction at baseline, 1month, 3 month, and 6 month Patient Satisfaction Score | — |
Countries
Thailand
Contacts
Public ContactSorravee Chalongkulwat
Thammasat University
Outcome results
None listed