Melasma Clinical Trial
Official title:
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
NCT number | NCT04597203 |
Other study ID # | si 082/2019 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2020 |
Est. completion date | February 2021 |
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
Status | Recruiting |
Enrollment | 20 |
Est. completion date | February 2021 |
Est. primary completion date | January 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Dermatology, Siriraj Hospital, Mahidol University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | score range 0-24 | 6 months | |
Primary | Melanin index measured by Mexameter® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma | measuring in au | 6 months | |
Primary | Average melanin measured by Antera3D® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma | measuring in au | 6 months | |
Primary | Patient satisfaction quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma | score 0 -100% | 6 months | |
Primary | Physician evaluation quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma | score 0 -100% | 6 months | |
Secondary | Safety of using combination of 755-nm picosecond alexandrite laser | Monitor side effect from picesecond alexandrite laser | 6 months | |
Secondary | Safety of using 2% hydroquinone | side effect of topical 2%Hydroquinone use | 6 months |
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