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Comparative study of effectiveness between 20% azelaic acid with low-fluence 1064-nm Nd:YAG picosecond laser and 20% azelaic acid alone in the treatment of melasma in Thai female patients, split-face, prospective study

Comparative study of effectiveness between 20% azelaic acid with low-fluence 1064-nm Nd:YAG picosecond laser and 20% azelaic acid alone in the treatment of melasma in Thai female patients, split-face, prospective study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230112004
Enrollment
20
Registered
2023-01-12
Start date
2023-01-10
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

Thai female patients aged 18-65 years old with bilateral symmetrical malar type melasma Melasma, picosecond laser, 1064 nm, azelaic acid

Interventions

Each patient treated by low fluence 1064-nm Nd:YAG picosecond laser every 2 weeks for 3 sessions on the right side of the face. Patients have to apply 20% azelaic acid cream twice daily to the melasma
1064-nm Nd:YAG picosecond laser with azelaic acid side,azelaic acid side

Sponsors

Institute of Dermatology, Bangkok, Thailand
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Thai female patients 2) Aged 18-65 years old 3) Diagnosed with bilateral symmetrical malar type melasma at the face 4) Can be able to attend and willing to be a subject in this study including being able to give a consent

Exclusion criteria

Exclusion criteria: 1) Taking oral contraceptive pills or receiving hormone replacement 2) In the period of pregnancy or lactation 3) Have underlying disease of autoimmune diseases such as SLE 4) Have underlying disease of thyroid diseases 5) Allergy to azelaic acid or preservatives in topical melasma treatment 6) Have a laser treatment on the face within 6 months before the study 7) Using topical melasma treatments such as kojic acid, hydroquinone, alpha arbutin and whitening agents within 4 weeks before the study 8) Treated melasma by chemical peeling agents within 3 months before the study 9) Using tranexamic acid or vitamin C within 3 months before the study 10) Taking or applying retinoid within 12 months before the study 11) Having an active asthma 12) Having a history of using antiepileptic drugs 13) Having skin infections or any other skin disease, for example, allergic dermatitis, cellulitis, erysipelas, herpes simplex and herpes zoster infection on the face

Design outcomes

Primary

MeasureTime frame
Melasma severity At baseline, 8 weeks, 12 weeks and 16 weeks after the baseline Hemi-Melasma Area and Severity Index

Secondary

MeasureTime frame
Physician global assessment At 8 weeks, 12 weeks and 16 weeks after the baseline Physician global assessment scores,Patient satisfaction At 8 weeks, 12 weeks and 16 weeks after the baseline Patient satisfaction scores ,Sides effects At baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks after the baseline Sides effects report

Countries

Thailand

Contacts

Public ContactNatthika Klaisung

Institute of Dermatology, Bangkok, Thailand

natthika.proud@gmail.com0964459592

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026