Enlarged facial pores Botulinum toxin Enlarged pores Microneedle
Conditions
Interventions
Participants will be treated with a microneedle-assisted drug delivery device(POTENZA) while simultaneously being topically applied with a solution containing 16 units of botulinum toxin mixed in 1 ml
Experimental Drug,Placebo Comparator Drug
Microneedling with infusion tip with botulinum toxin A,Microneedling with infusion tip with normal saline
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Technicalbiomed Co.,ltd,Merz Aesthetics. Thailand
Eligibility
Sex/Gender
All
Age
25 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Thai descendants 2. There are enlarged pores on both cheeks. By definition, enlarged pores must be visible to the naked eye (visible topographic enlarged facial pores) at a distance of 30 cm and examined by two dermatologists with a consensus.
Exclusion criteria
Exclusion criteria: 1. Pregnant, breastfeeding, or after giving birth for no more than three months or plan to become pregnant during six months. 2. Using vitamin A compounds or chemical peeling agents or injecting botulinum toxin on the cheek area in the last six months 3. History of allergy to anesthetics or botulinum toxin 4. History of hypertrophic scars or keloids 5. Open wounds, infected skin, or skin rashes on the face 6. Having underlying diseases such as diabetes, collagen-related disorders, immunodeficiencies, or having an underlying condition that the researcher considers to be unsafe if participating in the program, such as epilepsy 7. History of regularly using steroids or smoking. 8. History of using anticoagulants, antiplatelet agents, or ginkgo leaf extract. 9. Volunteers with an implanted pacemaker with an implanted metallic device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pore volume before treatment, 2 weeks, 1 month, 3 months, 6 months after treatment Antera 3D analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events 1 week, 2 weeks, 1 month, 3 months, 6 months after treatment Clinical evaluation,Sebum production 2 weeks, 1 month, 3 months, 6 months after treatment Sebumeter | — |
Countries
Thailand
Contacts
Public ContactThrit Hutachoke
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed