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The goal of this clinical trial is to evaluate the efficacy and safety of a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES when used as a moisturizer after QS-Nd:YAG 1064 nm low-fluence laser treatment for melasma and post-acne hyperpigmentation.
The study aims to answer the following main questions:
Participants will be female patients aged 18-60 years, clinically diagnosed with melasma or post-acne hyperpigmentation (skin types IV and V), who visit the Dermatology & Venereology Outpatient Clinic for QS-Nd:YAG 1064 low-fluence laser treatment. All participants will have undergone a 2-week priming period using either 2% hydroquinone cream or the test serum prior to laser treatment. Written informed consent is required.
Participants will be randomly assigned to receive either the test serum or 2% hydroquinone cream based on a coded allocation. The product will be applied twice daily after facial cleansing, and sunscreen will be used 15 minutes before outdoor activities. Treatment lasts for 2 weeks, with participants recording application times and any adverse effects in a diary. Evaluations-including facial photography, mMASI, mexameter, dermoscopy, Wood's lamp, and PAHPI-will be conducted at baseline and at 1, 2, and 4 weeks post-laser. Erythema and subjective assessment (VAS) will be performed 15 minutes after the laser procedure.
Full description
This study is a randomized, double-blind, placebo-controlled clinical trial aimed at evaluating the efficacy and safety of a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES as a moisturizer following QS-Nd:YAG 1064 nm low-fluence laser treatment in patients with melasma and post-acne hyperpigmentation. Medical history, physical examination, and laser procedures will be performed at the Dermatology and Venereology Clinic of Gatot Soebroto Central Army Hospital (RSPAD), Jakarta. Participants will be stratified based on their condition (melasma or post-acne hyperpigmentation) and randomly allocated using coded assignment into two groups. Group 1 (control) will receive 2% hydroquinone cream applied nightly, along with sunscreen with SPF >30 applied every morning. Group 2 (intervention) will receive the combination serum applied twice daily (morning and evening), along with the same SPF >30 sunscreen applied each morning. All products will be applied after facial cleansing, and sunscreen will be used 15 minutes prior to outdoor exposure. The treatment duration is 2 weeks, during which participants will record application times and any adverse effects in a diary. Assessments will be conducted at baseline, and at weeks 1, 2, and 4 post-laser, including standardized facial photography, modified Melasma Area and Severity Index (mMASI), mexameter readings, dermoscopy, Wood's lamp examination, and the Post-Acne Hyperpigmentation Index (PAHPI). Erythema scores and subjective assessments (VAS) will be recorded 15 minutes after the laser procedure.
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Inclusion criteria
Patients who are currently receiving or have received a priming regimen for at least two weeks prior to the laser procedure, consisting of either 2% hydroquinone cream or a serum containing Niacinamide 10%, Hyaluronic Acid, and HEPES.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
68 participants in 2 patient groups
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Central trial contact
Prof. Irma Bernadette S Sitohang, MD., PhD.
Data sourced from clinicaltrials.gov
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