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

NCT07121439 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-08-13

No results posted yet for this study

Summary

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.

Conditions

  • Melasma
  • Post-acne Hyperpigmentation

Interventions

DRUG

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

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.

DRUG

2% hydroquinone cream

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.

Sponsors & Collaborators

  • Dr.dr.Irma Bernadette, SpKK (K)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2025-11-28
Completion
2025-12-01

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121439 on ClinicalTrials.gov