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

Phase 2

Completed

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

• Registration Number: TCTR20230112004
• Lead Sponsor: Institute of Dermatology, Bangkok, Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-12
• Study Completion: 2023-05-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Melasma severity At baseline, 8 weeks, 12 weeks and 16 weeks after the baseline Hemi-Melasma Area and Severity Index

Secondary Outcome Measures

Name	Time	Method
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