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Efficacy of Fractional Microneedle Radiofrequency Combined with Topical Dihydromyricetin for the Treatment of Photoaging: A Double-Blind Randomized Controlled Trial

Efficacy of Fractional Microneedle Radiofrequency Combined with Topical Dihydromyricetin for the Treatment of Photoaging: A Double-Blind Randomized Controlled Trial

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260129001
Enrollment
32
Registered
2026-01-29
Start date
2025-10-03
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

Fractional Microneedle Radiofrequency Combined Dihydromyricetin Photoaging Fractional Microneedle Radiofrequency Combined Dihydromyricetin Photoaging

Interventions

Participants in this group will receive non-insulated fractional microneedle radiofrequency treatment at standardized parameters Immediately following each FMR session, a topical DHM-based cream will
Experimental Device,Placebo Comparator Device
Fractional Microneedle Radiofrequency Combined with Topical Dihydromyricetin,Fractional Microneedle Radiofrequency Combined with Topical placebo cream

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 20 to70 years, of either sex. 2. Clinically diagnosed by a dermatologist with facial melasma involving both sides of the face, with no requirement to specify lesion size, and willing to refrain from using any other facial skincare or cosmetic treatments during the study period, including botulinum toxin injections, dermal fillers, laser treatments, thread lifting, or dermabrasion. 3. Able to comply with all study procedures, attend scheduled follow-up visits throughout the study period, and promptly report any adverse events related to the study.

Exclusion criteria

Exclusion criteria: 1. History of systemic retinoid (acitretin, isotretinoin), methotrexate, photosensitizing or phototoxic drugs, tranexamic acid, glutathione, or vitamin supplements (A, B, etc.) use within 6 months prior to study initiation. 2. History of microdermabrasion, IPL, pigment laser treatments, ablative or non-ablative resurfacing lasers, chemical peels, botulinum toxin, or dermal filler injections on the face within 6 months prior to the study. 3. Use of topical medications for melasma within 1 month before study enrollment. 4. Presence of photosensitive dermatoses, infectious or inflammatory skin diseases, or inflammatory acne in the treatment area. 5. Personal or family history of skin cancer. 6. History of herpes simplex infection on the face. 7. History of hypertrophic scars or keloids. 8. Presence of serious chronic illnesses requiring continuous treatment, such as cirrhosis, chronic renal failure, malignancy, or immunodeficiency disorders. 9. Current use of anticoagulant medications. 10. Pregnant or breastfeeding women, or those planning pregnancy or not using contraception. 11. Current smokers or individuals who smoke regularly. 12. Inability to attend treatment sessions or follow-up visits according to the study schedule. 13. History of allergy to local anesthetics.

Design outcomes

Primary

MeasureTime frame
efficacy 0,2,4,6,8,10,18 week modified melasma area severity index

Secondary

MeasureTime frame
Melanin average level,vessel density measurement, 0,8,10,18 week antera camera, optical coherence tomography ,melanin pigment, collagen in dermis, thickness of basement membrane 0,10 week histological analysis(Fontana Masson stain ,Masson trichrome ,Periodic acid-Schiff stain ),side effect of Fractional Microneedle Radiofrequency Combined with Topical Dihydromyricetin compare with Fractional Microneedle Radiofrequency Combined with Topical Placebo cream 0,2,4,6,10,18 week questionnaire,Satisfaction questionnaire 18th week 9-point rating scale

Countries

Thailand

Contacts

Public ContactWareeporn Disphanurat

Thammasat university hospital

dwareeporn@gmail.com029259435

Outcome results

None listed

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