Melasma Melasma, facial hyperpigmentation, fractional laser therapy, non-ablative laser, erbium laser, thulium laser, topical polydeoxyribonucleotide, skin pigmentation disorder
Conditions
Interventions
Participants will receive dual non ablative fractional laser treatment using erbium 1550 nm and thulium 1927 nm applied to both cheeks according to standard clinical practice. Laser parameters includi
Active Comparator Device,Experimental Device
Dual non-ablative fractional laser (erbium 1550 nm and thulium 1927 nm),Dual non-ablative fractional laser (erbium 1550 nm and thulium 1927 nm) plus topical polydeoxyribonucleotide
Sponsors
Chulabhorn International College of Medicine
Eligibility
Sex/Gender
All
Age
25 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Thai participants diagnosed with melasma presenting as symmetrical lesions on the cheeks, without restriction on disease severity, and with Fitzpatrick skin types III to V. 2. Participants who are willing to participate in this study and provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding participants. 2. History of dermal filler injection or biostimulator injection in the cheek area within the past one year. 3. Currently receiving laser treatment or treatment with any energy based device. 4. History of laser or energy based device treatment such as laser or radiofrequency on the face within six months prior to study enrollment. 5. Current use of systemic treatments, including oral or injectable medications such as immunosuppressive agents or systemic corticosteroids at a dose greater than twenty milligrams per day. 6. Participants using topical treatments for melasma will not be excluded; however, they must continue using the same topical products and regimen throughout the study period. 7. History of allergy to any component of the topical product, including polydeoxyribonucleotide, polynucleotide, hyaluronic acid, panthenol, ascorbic acid, glutathione, or tranexamic acid. 8. Presence of bacterial or viral infection or active inflammation on the face. 9. Presence of unhealed wounds in the treatment area. 10. Presence of abnormal skin conditions in the treatment area, such as ulceration, psoriasis, eczema, rash, or rosacea. 11. History of herpes infection involving the face or lips. 12. History of surgery in the treatment area within three months prior to study enrollment. 13. History of facial laser treatment or chemical peeling within three months prior to study enrollment. 14. Presence of systemic diseases or medical conditions that may affect treatment safety or efficacy, including: 15. Immunodeficiency conditions (Autoimmune diseases involving the skin, Current or previous history of malignancy or skin cancer, History of radiotherapy or chemotherapy, Cardiovascular disease, Poorly controlled endocrine disorders, such as uncontrolled diabetes mellitus, Tuberculosis, Febrile condition, Acute neuralgia or peripheral neuropathy, Renal failure or hepatic failure) 16. History of herpes simplex labialis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Melasma Area and Severity Index score At baseline and 1,2,3,4,5 months after initiation of treatment Standardized clinical photography with blinded assessmen | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in facial pigmentation severity At baseline and 1,2,3,4,5 months after initiation of treatment Melanin index by mexameter,Incidence of treatment related adverse events At baseline and 1,2,3,4,5 months after initiation of treatment Participant satisfaction questionnaire,Participant satisfaction At baseline and 1,2,3,4,5 months after initiation of treatment Participant satisfaction questionnaire | — |
Countries
Thailand
Contacts
Public ContactSunatra Nittayavardhana
Chulabhorn International College of Medicine, Thammasat University
Outcome results
None listed