MelasmaNCT07121439
Efficacy and Safety of a Combined Serum Containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES
A study testing a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES and 2% hydroquinone cream in people with Melasma and Post-acne Hyperpigmentation, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma, Post-acne Hyperpigmentation
- What is being tested?
- a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES and 2% hydroquinone cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Sep 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Gatot Soebroto Central Army Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10410
Prof. Irma Bernadette S Sitohang, MD., PhD., +62818130761, irma_bernadette@yahoo.com
Prof. Irma Bernadette S Sitohang, MD., PhD
About this study
Official title: 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
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:
Read more
- 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.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial aimed at evaluating the efficacy and safety of a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES as a moisturizer following QS-Nd:YAG 1064 nm low-fluence laser treatment in patients with melasma and post-acne hyperpigmentation. Medical history, physical examination, and laser procedures will be performed at the Dermatology and Venereology Clinic of Gatot Soebroto Central Army Hospital (RSPAD), Jakarta. Participants will be stratified based on their condition (melasma or post-acne hyperpigmentation) and randomly allocated using coded assignment into two groups. Group 1 (control) will receive 2% hydroquinone cream applied nightly, along with sunscreen with SPF >30 applied every morning. Group 2 (intervention) will receive the combination serum applied twice daily (morning and evening), along with the same SPF >30 sunscreen applied each morning. All products will be applied after facial cleansing, and sunscreen will be used 15 minutes prior to outdoor exposure. The treatment duration is 2 weeks, during which participants will record application times and any adverse effects in a diary. Assessments will be conducted at baseline, and at weeks 1, 2, and 4 post-laser, including standardized facial photography, modified Melasma Area and Severity Index (mMASI), mexameter readings, dermoscopy, Wood's lamp examination, and the Post-Acne Hyperpigmentation Index (PAHPI). Erythema scores and subjective assessments (VAS) will be recorded 15 minutes after the laser procedure.
- Conditions
- Melasma, Post-acne Hyperpigmentation
- Being tested
- a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES, 2% hydroquinone cream
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPESDrug
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 creamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 2% hydroquinone cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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%
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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%
Measured: 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%
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start15 Sep 2025 (estimated)
- Primary completion28 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121439
- Sponsor's protocol ID
- melab3
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07121439
- Acronym / sponsor ID
- melab3
- Conditions
- Melasma, Post-acne Hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)University, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 28 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial aimed at evaluating the efficacy and safety of a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES as a moisturizer following QS-Nd:YAG 1064 nm low-fluence laser treatment in patients with melasma and post-acne hyperpigmentation. Medical history, physical examination, and laser procedures will be performed at the Dermatology and Venereology Clinic of Gatot Soebroto Central Army Hospital (RSPAD), Jakarta. Participants will be stratified based on their condition (melasma or post-acne hyperpigmentation) and randomly allocated using coded assignment into two groups. Group 1 (control) will receive 2% hydroquinone cream applied nightly, along with sunscreen with SPF >30 applied every morning. Group 2 (intervention) will receive the combination serum applied twice daily (morning and evening), along with the same SPF >30 sunscreen applied each morning. All products will be applied after facial cleansing, and sunscreen will be used 15 minutes prior to outdoor exposure. The treatment duration is 2 weeks, during which participants will record application times and any adverse effects in a diary. Assessments will be conducted at baseline, and at weeks 1, 2, and 4 post-laser, including standardized facial photography, modified Melasma Area and Severity Index (mMASI), mexameter readings, dermoscopy, Wood's lamp examination, and the Post-Acne Hyperpigmentation Index (PAHPI). Erythema scores and subjective assessments (VAS) will be recorded 15 minutes after the laser procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPESParticipants receive the test serum containing Melasyl™, Niacinamide 10%, Hyaluronic Acid, and HEPES every morning and night, plus SPF >30 sunscreen every morning. |
| control | Active comparator | Drug: 2% hydroquinone creamParticipants receive 2% hydroquinone cream at night and SPF >30 sunscreen every morning. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPESSubjects 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 | treatment |
| 2% hydroquinone creamSubjects 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. | Drug | control |
Primary outcome
Change of Subjective Pain Evaluation
Time frame: 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
Assessed using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain
Change of Eryhtema Score
Time frame: 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
Based on Clinical Erythema Assessment Scale. Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema
Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score
Time frame: 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
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%
Change of the Post-Acne Hyperpigmentation Index (PAHPI) score
Time frame: 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
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.
Change of Melasma Severity based on Dermoscopy
Time frame: 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
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.
Change of Melasma Severity based on Wood's Lamp
Time frame: 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
Epidermal Type/ Dermal Typed/ Mixed Typed
Change of Melanin Index Based on Mexameter
Time frame: 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
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%
Change of Erytema Index Based on Mexameter
Time frame: 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
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%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES and 2% hydroquinone cream in people with Melasma and Post-acne Hyperpigmentation, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Irma Bernadette S Sitohang, MD., PhD. (+62818130761, irma_bernadette@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Subjective Pain Evaluation (time frame: 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.