Enlarged facial pores Enlarged facial pores, enlarged pores, dilated pores, pores, microneedle radiofrequency, micro focused ultrasound, focused ultrasound
Conditions
Interventions
Microneedle radiofrequency (Sylfirm X
X, Viol Co., Ltd., Seongnam, Korea) needle XE mode continuous wave 2, pulse duration 160 msec,
depth 1.5 mm, energy level 4, 1 pass) will be treated on one side o
Experimental Device,Active Comparator Device
Microneedle radiofrequency,Micro focused ultrasound
Sponsors
Strategic Wisdom and Research Institute
Quantum Healthcare Thailand,Merz Aesthetics Thailand,Beiersdorf Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old 2. Generally healthy with no serious chronic conditions 3. Have enlarged pores on both cheeks equally and a score of 3 or higher on the Criteria of Visual Assessment for Pores 4. Able to attend scheduled appointments and comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Infection or wound: Participants with infections or wounds at the treatment site 2. Uncontrolled Inflammatory Acne (Acne Vulgaris): - Moderate acne: More than 10 small papules and pustules and/or fewer than 5 nodules. - Severe acne: Numerous papules and pustules, many nodules or cysts, inflamed nodules that persist, recurrent, or have draining sinuses. 3. Immunosuppression: Participants with immunosuppressive conditions. 4. Active or recent malignancy. 5. History of keloid or hypertrophic scarring. 6. History of herpes infection. 7. History of connective tissue disorders. 8. History of psychiatric disorders. 9. Presence of electronic devices or metallic implants in the body, such as pacemakers or defibrillators. 10.Use of vitamin A derivatives within 3 months prior to the study. 11. Recent Facial Treatments: laser, dermabrasion, chemical peeling, radiofrequency, or focused ultrasound treatments on the cheeks within 3 months prior to the study. 12. Filler injections in the cheek area within 6 months. 13. Botulinum toxin injections in the face within 3 months. 14. History of anesthesia allergy. 15. Pregnancy, lactation or women planning to conceive, currently pregnant, or breastfeeding. 16. Participants who refuse or request to withdraw from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pore volume baseline, week 4, 8, 12, 16, 20 and 24 after treatment Antera3D,Assessment of pores by physician baseline, week 4, 8, 12, 16, 20 and 24 after treatment Visual assessment of pore,Improvement of pores by volunteers baseline, week 4, 8, 12, 16, 20 and 24 after treatment 20-point visual analog scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Sebum level baseline, week 4, 8, 12, 16, 20 and 24 after treatment Sebumeter,Skin elasticity baseline, week 4, 8, 12, 16, 20 and 24 after treatment Cutometer,Skin roughness baseline, week 4, 8, 12, 16, 20 and 24 after treatment Antera3D,Adverse effects (e.g. erythema, edema, erosion, burn, bullae, post inflammatory hyperpigmentation, post inflammatory hypopigmentation and scar) baseline, week 4, 8, 12, 16, 20 and 24 after treatment Patient report,Pain score baseline and week4 10-point visual analog scale | — |
Countries
Thailand
Contacts
Public ContactPintusorn Kungvalpivat
Department of Dermatology, Faculty of Medicine, Srinakharinwirot University
Outcome results
None listed