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Efficacy and Safety of Microneedle Monopolar Radiofrequency and Poly-L-lactic Acid (PLLA-SCA) Compared to sterile water for the Treatment of Atrophic Acne Scars in Thailand

Efficacy and Safety of Microneedle Monopolar Radiofrequency and Poly-L-lactic Acid (PLLA-SCA) Compared to sterile water for the Treatment of Atrophic Acne Scars in Thailand

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250803007
Enrollment
24
Registered
2025-08-03
Start date
2024-04-08
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne scar Acne scar

Interventions

Participants face was applied with PLLA then treated with micro needling radiofrequency monthly for 3 sessions,Participants face was applied with sterile water then treated with micro needling radiofr
Experimental Device,Active Comparator Device
Microneedling RF + PLLA,Microneedling RF + Sterile water

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Male or female 20-50 years old 2. Participants with at least moderate severity of acne scar

Exclusion criteria

Exclusion criteria: 1. Participants who are pregnant or breastfeeding. 2. Participants with a medical history of collagen-related disorders, such as Cushing's syndrome or Ehlers-Danlos syndrome. 3. Participants with dermatitis, wounds, or active skin infections on the face. 4. Participants diagnosed with cancer, currently undergoing cancer treatment, or with a history of skin cancer in the treatment area. 5. Participants with immunodeficiency conditions, including those infected with HIV or diagnosed with AIDS. 6. Participants with a history of allergy to local anesthetics. 7. Participants with a history of abnormal photosensitivity. 8. Participants who have received facial treatments involving dermal fillers, botulinum toxin, collagen biostimulators, platelet-rich plasma (PRP), or thread lifting within 6 months prior to study enrollment. 9. Participants who have undergone facial laser treatment for acne scars within 6 months prior to study enrollment. 10. Participants with a history of keloids or active skin lesions in the treatment area. 11. Participants who have used isotretinoin for acne treatment within 6 months prior to study enrollment. 12. Participants who have used retinoids or vitamin A derivatives within 3 months prior to study enrollment. 13. Participants with a history of psychiatric disorders. 14. Participants with any conditions deemed by the investigator to pose potential safety risks. 15. Participants who do not consent to photography for treatment evaluation purposes.

Design outcomes

Primary

MeasureTime frame
Texture Baseline, 1 month after 1st tteatment, 1 month after 2nd treatment, 1 , 3 and 6 months after 3rd treatment Antera3D,Volume depression Baseline, 1 month after 1st tteatment, 1 month after 2nd treatment, 1 , 3 and 6 months after 3rd treatment Antera3D,Acne scar severity Baseline, 1 month after 1st tteatment, 1 month after 2nd treatment, 1 , 3 and 6 months after 3rd treatment Goodman and Baron's Quantitative Global Acne Scarring Grading System

Secondary

MeasureTime frame
Melanin index Baseline, 1 month after 1st tteatment, 1 month after 2nd treatment, 1 , 3 and 6 months after 3rd treatment Mexameter,Pigmentation Baseline, 1 month after 1st tteatment, 1 month after 2nd treatment, 1 , 3 and 6 months after 3rd treatment Antera3D,Erythema index Baseline, 1 month after 1st tteatment, 1 month after 2nd treatment, 1 , 3 and 6 months after 3rd treatment Mexameter,Redness Baseline, 1 month after 1st tteatment, 1 month after 2nd treatment, 1 , 3 and 6 months after 3rd treatment Antera3D,Safety Baseline, 1 month after 1st tteatment, 1 month after 2nd treatment, 1 , 3 and 6 months after 3rd treatment ADverse event,Physician assessment Baseline, 1 month after 1st tteatment, 1 month after 2nd treatment, 1 , 3 and 6 months after 3rd treatment 2 independent dermatologists

Countries

Thailand

Contacts

Public ContactWoraphong Manuskiatti

Faculty of medicine Siriraj hospital, Mahidol university

woraphong.man@mahidol.ac.th024197777

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026