Melasma
Conditions
Brief summary
This study aims to assess the efficacy and safety of using combination of 755-nm picosecond alexandrite laser and 2% hydroquinone compared with 2% hydroquinone alone for the treatment of melasma: A randomized split-face controlled trial
Interventions
DEVICE755-nm picosecond alexandrite laser with topical 2% hydroquinone
treatment one side of the face with 755-nm picosecond alexandrite laser with topical 2% hydroquinone
DRUGtopical 2% hydroquinone
treatment one side of the face with topical 2% hydroquinone
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Both male and female age 18-60 years * Melasma on both cheeks - epidermal or mixed type * Fitzpatrick Skin type III-V
Exclusion criteria
* History of retinoid or other keratolytic drugs used within 6 months before enrolled * History of keloid * photosensitivity * Immunocompromised host
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Melanin index measured by Mexameter® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma | 6 months | measuring in au |
| Patient satisfaction quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma | 6 months | score 0 -100% |
| Physician evaluation quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma | 6 months | score 0 -100% |
| Modified melasma area and severity index score(mMASI) - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma of using combination of 755-nm picosecond alexandrite laser and 2% hydroquinone | 6 months | score range 0-24 |
| Average melanin measured by Antera3D® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma | 6 months | measuring in au |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of using 2% hydroquinone | 6 months | side effect of topical 2%Hydroquinone use |
| Safety of using combination of 755-nm picosecond alexandrite laser | 6 months | Monitor side effect from picesecond alexandrite laser |
Countries
Thailand
Contacts
Primary Contactworaphong Manuskiatti, M.D.
Backup ContactChadakan Yan, M.D.
Outcome results
None listed