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The Efficacy and Safety of a Combined Serum Containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and Hydroxyethylpiperazine Ethane Sulfonic Acid Following Low-Fluence Q-Switched Nd:YAG 1064 nm Laser Treatment for Melasma and Post-Acne Hyperpigmentation Therapy
Sponsor study identifier
interventional
68
1 country
1
Study Start
September 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 28, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 6, 2025
Actual (reported)August 13, 2025
Actual (reported)September 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 28, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Participants receive the test serum containing Melasyl™, Niacinamide 10%, Hyaluronic Acid, and HEPES every morning and night, plus SPF \>30 sunscreen every morning.
Participants receive 2% hydroquinone cream at night and SPF \>30 sunscreen every morning.
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGatot Soebroto Central Army Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10410, Indonesia
First Submitted
August 6, 2025
First Posted
August 13, 2025
Study Start
September 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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.
Contact the study team to confirm eligibility.
Primary Completion
November 28, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 13, 2025
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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