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

NCT07121439 | Not Yet Recruiting

• 1 other identifier: melab3
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• 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

  baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser

• Change of Eryhtema Score

  Based on Clinical Erythema Assessment Scale. Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema

  baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser

• Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score

  the range of values for mMASI is between 0 and 24 which can then be divided into mild melasma (0-8), moderate (8-16), and severe (16-24). improvement occurs if the mMASI score decreases by \<50% from the previous visit worsening if score persists or mMASI Score Increase \>50%

  baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser

• Change of the Post-Acne Hyperpigmentation Index (PAHPI) score

  On physical examination, the severity of post-inflammatory hyperpigmentation in patients with acne vulgaris was assessed using the Post-Acne Hyperpigmentation Index (PAHPI). The PAHPI score ranges from 6 to 22, with a score of 6 indicating mild post-acne hyperpigmentation and a score of 22 indicating severe post-acne hyperpigmentation.

  baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser

• Change of Melasma Severity based on Dermoscopy

  based on Dermoscopy Telangiectasis score assessment using a 5-point dermoscopy-scale: 0 = No visible capillaries. 1 = Elongated capillaries accompanied by dilation, not visible to the naked eye. 2 = Moderate telangiectasis that is beginning to be visible to the naked eye. 3 = Severe telangiectasis characterized by reduced capillary loops. 4 = Very severe telangiectasis characterized by dilatation and loss of capillary loops.

  baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser

• Change of Melasma Severity based on Wood's Lamp

  Epidermal Type/ Dermal Typed/ Mixed Typed

  baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser

• Change of Melanin Index Based on Mexameter

  improves if there is a decrease in melanin levels \> 50% from the initial visit It is said to be bad or persistent if there is no decrease in melanin levels or there is a decrease of \<50%

  baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser

• Change of Erytema Index Based on Mexameter

  improves if there is a decrease in Erytema levels \> 50% from the initial visit It is said to be bad or persistent if there is no decrease in erythema levels or there is a decrease of \<50%

  baseline; 1 weeks post QS-Nd:YAG 1064 nm low-fluence laser; 2 weeks post QS-Nd:YAG 1064 nm low-fluence laser and 4 weeks post QS-Nd:YAG 1064 nm low-fluence laser

Study Arms (2)

treatment

EXPERIMENTAL

Participants receive the test serum containing Melasyl™, Niacinamide 10%, Hyaluronic Acid, and HEPES every morning and night, plus SPF \>30 sunscreen every morning.

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

control

ACTIVE COMPARATOR

Participants receive 2% hydroquinone cream at night and SPF \>30 sunscreen every morning.

Drug: 2% hydroquinone cream

Interventions

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

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.

treatment

2% hydroquinone cream DRUG

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.

control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr.dr.Irma Bernadette, SpKK (K): lead

Study Sites (1)

Gatot Soebroto Central Army Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10410, Indonesia

Location

MeSH Terms

Conditions

Melanosis

Interventions

Niacinamide; Hyaluronic Acid; HEPES

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Glycosaminoglycans; Polysaccharides; Carbohydrates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Piperazines

Central Study Contacts

Prof. Irma Bernadette S Sitohang, MD., PhD.

CONTACT

+62818130761; irma_bernadette@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: September 15, 2025
• Primary Completion: November 28, 2025
• Study Completion: December 1, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

ID (1)