Combination Serum for Melasma and Post-Acne Hyperpigmentation
a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES
+ 2% hydroquinone cream
Melanosis+2
+ Pigmentation Disorders
+ Skin Diseases
Treatment Study
Summary
Study start date: September 15, 2025
Actual date on which the first participant was enrolled.This clinical trial is designed to explore how effective and safe a special serum is in treating skin conditions like melasma and post-acne dark spots. The serum contains a mix of Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES, and is applied after a specific type of laser treatment. The trial focuses on people who have either melasma or dark spots left after acne. The aim is to see if using this serum can improve skin appearance and possibly offer a better treatment option than what's currently available, which is important for those dealing with these skin conditions. Participants in the study are divided into two groups, with one group using the special serum twice a day and the other using a cream with a known ingredient, hydroquinone, each night. Both groups use a sunscreen with SPF over 30 every morning. The trial lasts for two weeks, during which participants keep a diary of their product use and any side effects. The effectiveness of the treatments is measured through various methods like facial photography and skin assessments at different times, including after the laser treatment, to track changes in skin condition and ensure safety.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.68 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Gatot Soebroto Central Army Hospital
Jakarta Pusat, IndonesiaOpen Gatot Soebroto Central Army Hospital in Google Maps