Efficacy and Safety of a Combined Serum Containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES

N/ANot Yet RecruitingNCT07121439

Dr.dr.Irma Bernadette, SpKK (K)68 enrolled

Overview

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: * Does the combination serum reduce hyperpigmented lesions after laser treatment for melasma and post-acne hyperpigmentation? * Does the serum improve skin hydration following laser therapy for melasma? * Is the combination serum safe for use after laser treatment, without causing irritation or adverse effects? 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.

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.

Interventions

a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPESDRUG

Subjects were randomized to receive a combination serum The combination serum contained Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES. applied twice daily, following QS-Nd:YAG 1064 nm low-fluence laser treatment. Clinical evaluations were conducted at baseline and at Weeks 1, 2, and 4 post-laser to assess pigmentation improvement, erythema, and overall skin condition.

2% hydroquinone creamDRUG

Subjects were randomized to received 2% hydroquinone cream, applied once daily at night, following QS-Nd:YAG 1064 nm low-fluence laser treatment. Clinical evaluations were conducted at baseline and at Weeks 1, 2, and 4 post-laser to assess pigmentation improvement, erythema, and overall skin condition.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female, aged 18-60 years. * Patients diagnosed with post-acne hyperpigmentation and melasma based on clinical examination and Wood's lamp evaluation, with Fitzpatrick skin types IV and V. * Patients visiting the Dermatology and Venereology Outpatient Clinic and scheduled to undergo QS Nd:YAG 1064 nm low-fluence laser treatment. 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. \- Willing to participate in the study and provide written informed consent after receiving a complete explanation of the study procedures. Exclusion Criteria: * Pregnant, breastfeeding, or currently taking oral contraceptives at the time of evaluation. * History of systemic retinoid use within the past three months. * History of or ongoing treatment for hormonal/endocrine disorders or other severe systemic illnesses. * Currently undergoing immunosuppressive therapy. * Difficulty adhering to treatment protocols.

Outcomes

Primary Outcomes

Change of Subjective Pain Evaluation

Assessed using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain