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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorDr.dr.Irma Bernadette, SpKK (K)

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES
  • 2% hydroquinone cream

Treatment groups

68 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dr.dr.Irma Bernadette, SpKK (K)

Lead sponsor

Indonesia University

Sponsor institution