Efficacy of HOSPSL 577nm laser in Melasma Treatment
Phase 4
Completed
- Conditions
- Patients with melasma that did not response to at least 2% hydroquinone cream-containing regimen after 3 monthsmelasmalaser577nm
- Registration Number
- TCTR20210618003
- Lead Sponsor
- Siriraj Skin Laser Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
1. Age 20-65 years old
2. Melasma (Epidermal or mixed type) on both side of face
3. Do not response to at least 2% hydroquinone-containing regimen after at least 3 months usage
4. Fizpatrick skin type III-V
5. Willing to participate and give written informed consent
Exclusion Criteria
1. Pregnancy or lactation
2. Dermatitis or wound on face
3. Has other type(s) of pigmented lesions (such as seborrheic keratosis, lentigines, freckles, Hori's nevus, or nevus of Ota) in the melasma area
4. History of hormonal treatment within 1 month before the study participation
5. Recieve any chemical peelings or laser treatment on the face within 6 months before the study participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: melanin and erythema index Baseline, wk2, wk4, wk8, wk12, wk16, wk20, wk28, wk40 Mexameter ,Efficacy: Clinical grading score Baseline, wk2, wk4, wk8, wk12, wk16, wk20, wk28, wk40 mMASI (modified Melasma Area and Severity Index) score,Efficacy: Physician clinical photo evaluation wk2, wk4, wk8, wk12, wk16, wk20, wk28, wk40 Clinical photography,Efficacy: Patient self assessment wk2, wk4, wk8, wk12, wk16, wk20, wk28, wk40 VAS (visual analog scale)
- Secondary Outcome Measures
Name Time Method Safety: Adverse effect evaluation wk2, wk4, wk8, wk12, wk16, wk20, wk28, wk40 Physician evaluation,Pain from laser Baseline, wk4, wk8, wk12, wk16 pain score