Efficacy and Safety of a Combined Serum Containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES
NCT ID: NCT07121439
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
68 participants
INTERVENTIONAL
2025-09-15
2025-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS
NCT07071363
A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma
NCT03049059
A Clinical Study to Evaluate the Effect of Facial Serum Q69 in Moderating the Appearance of Mild to Moderate Melasma
NCT05013801
EFFICACY and TOLERABILITY of TESTED FORMULA VS. HYDROQUINONE 4% in the TREATMENT of FACIAL MELASMA
NCT06787846
Combination Alexandrite Laser and Topical Therapy vs Topical Therapy Alone for Treatment of Melasma
NCT02095756
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
treatment
Participants receive the test serum containing Melasyl™, Niacinamide 10%, Hyaluronic Acid, and HEPES every morning and night, plus SPF \>30 sunscreen every morning.
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.
control
Participants receive 2% hydroquinone cream at night and SPF \>30 sunscreen every morning.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
60 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dr.dr.Irma Bernadette, SpKK (K)
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr.dr.Irma Bernadette, SpKK (K)
Prof. Dr. dr. Irma Bernadette S. Sitohang, Sp.D.V.E., Subsp.D.K.E. - Head of Cosmetic Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gatot Soebroto Central Army Hospital
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
melab3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.