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Evaluation of Efficacy and Safety of the 640-nm light-emitting diode in the Treatment of Melasma in Asians

Evaluation of Efficacy and Safety of the 640-nm light-emitting diode in the Treatment of Melasma in Asians

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250207005
Enrollment
30
Registered
2025-02-07
Start date
2024-09-24
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

participant with melasma 640-nm light-emitting diode, Melasma

Interventions

Participants is treated with 640-nm light-emitting diode for 10 session total duration for 5 weeks. Patient then received follow up at 1-,3- and 6 months after complete treatment
Experimental Device
640-nm light-emitting diode

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years and older, both male and female. 2. Asian individuals with Fitzpatrick Skin Type III-V. 3. Diagnosed with melasma by the physician. 4. Have melasma on both sides of the face. 5. Patients who consent to participate in the project voluntarily and agree to receive treatment with a light-emitting diode at the positions specified in the research protocol.

Exclusion criteria

Exclusion criteria: 1. Participants who are pregnant or breastfeeding. 2. Participants with inflammatory skin rashes, wounds, or infections on the face. 3. Participants with light-sensitive rashes such as various photodermatitis, lupus erythematosus, and those with a history of skin cancer on the face. 4. Participants who have used hormones or contraceptives within the last 3 months. 5. Participants who have been treated for melasma with topical or oral medications within the last 3 months. 6. Participants who have been treated for melasma with facial laser treatments within the last 3 months. 7. Participants who have been treated with platelet-rich plasma injections within the last 12 months. 8. Participants who have received facial injections to stimulate collagen or reduce hyperpigmentation, such as polycaprolactone, hyaluronic acid, polydioxanone, poly-L-lactic acid, or calcium hydroxyapatite within the last 12 months. 9. Participants with severe chronic illnesses such as advanced-stage cancer or end-stage renal failure. 10. Participants diagnosed with a mental disorder by a psychiatrist. 11. Participants who do not consent to having photographs taken for treatment assessment

Design outcomes

Primary

MeasureTime frame
Average melanin concentration Baseline, treatment 6 (2 weeks after start treatment), 1-,3- and 6 months after treatment antera,Average erythema concentration Baseline, treatment 6 (2 weeks after start treatment), 1-,3- and 6 months after treatment antera,melanin level Baseline, treatment 6 (2 weeks after start treatment), 1-,3- and 6 months after treatment mexameter,erythema level Baseline, treatment 6 (2 weeks after start treatment), 1-,3- and 6 months after treatment mexameter

Secondary

MeasureTime frame
physician assessment score Baseline, treatment 6 (2 weeks after start treatment), 1-,3- and 6 months after treatment photo,patient assessment score Baseline, treatment 6 (2 weeks after start treatment), 1-,3- and 6 months after treatment global aesthetic improvement score,Modified Melasma area and severity index score (mMASI score) Baseline, treatment 6 (2 weeks after start treatment), 1-,3- and 6 months after treatment Modified Melasma area and severity index score (mMASI score) ,adverse event Baseline, treatment 6 (2 weeks after start treatment), 1-,3- and 6 months after treatment note,pain score treatment sessions visual analog score

Countries

Thailand

Contacts

Public ContactWoraphong Manuskiatti

Faculty of Medicine Siriraj Hospital, Mahidol University

woraphong.man@mahidol.ac.th6624197000

Outcome results

None listed

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