MelasmaNCT06677931
Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Melasma
A study testing 1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell-derived exosomes. in people with Melasma, run by Fujian Medical University Union Hospital at 2 sites in China.
Trial summary
Melasma is a refractory skin disease with a complex pathogenesis and difficult treatment. Research has found that mesenchymal stem cell-derived exosomes have effects such as anti-wrinkle formation, anti-inflammation, antioxidant properties, skin whitening, and promotion of skin regeneration. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- 1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell-derived exosomes.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 28 Aug 2024to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 60 years with good overall health.
- Diagnosed with melasma according to clinical diagnostic criteria and efficacy standards (revised edition), with facial skin lesions.
- Fully understands and comprehends the content and significance of the study, implementation plan, potential benefits, risks, mitigation measures, participant rights and obligations (including privacy protection and voluntary withdrawal), and willingly signs the informed consent form to participate in the clinical study, and can cooperate well.
- Exclusion of inflammatory post-pigmentary disorders, malar melasma, Riehl's melanosis, pigmentary lichenoid dermatosis, and other skin diseases.
- Agrees not to use other cosmetic treatments related to the study during the research period.
Who cannot join
- Patients who refuse to sign the informed consent form to participate in the trial.
- History of significant organ diseases, autoimmune diseases, or immune dysfunction.
- Abnormal coagulation function, current use of anticoagulants, tendency for thrombosis, or family history of genetic diseases.
- Pregnant or lactating women.
- Patients who have taken oral contraceptives or hormone replacement therapy during the study period or in the past 12 months.
- Patients with a keloid-prone constitution.
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- Locally damaged or actively affected by other skin diseases.
- History of severe multiple allergies, genetic allergies, photosensitivity or history of photosensitive drugs such as sulfonamides and tetracyclines, allergy to local anesthetics, lidocaine components, or planned desensitization therapy during the study.
- History of post-inflammatory hyperpigmentation.
- Previously treated for melasma.
- Previous chemical peels, abrasion procedures, or other resurfacing treatments on the face.
- Chronic skin diseases, especially infectious, allergic, and inflammatory systemic skin diseases such as widespread eczema, pemphigus, pemphigoid, etc.
- Patients currently participating in other clinical studies.
- Other reasons deemed unsuitable for the clinical study by the investigator.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chenxiaosong
Fujian, Fuzhou, 350001
Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, 350001
About this study
Official title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Melasma, a Prospective, Randomized, Controlled Clinical Trial
Melasma is a refractory skin disease with a complex pathogenesis and difficult treatment. Research has found that mesenchymal stem cell-derived exosomes have effects such as anti-wrinkle formation, anti-inflammation, antioxidant properties, skin whitening, and promotion of skin regeneration. Recent studies show that there is damage to the basement membrane in melasma skin lesions, and the regenerative repair function of mesenchymal stem cell-derived exosomes can repair the damaged basement membrane in melasma skin lesions, thereby effectively treating melasma. This study aims to observe the therapeutic effect of umbilical cord mesenchymal stem cell-derived exosomes combined with 1565 non-ablative fractional laser treatment for melasma, verify the enhancement effect of 1565 non-ablative fractional laser, and also explore a new combined treatment method for melasma that is effective, low in side effects, low in recurrence rate, and provides good patient comfort.
Read the detailed description
Exosomes are small, uniform lipid bilayer vesicles with a molecular diameter of 30-150 nanometers, formed by cells and actively secreted into the extracellular space. They contain proteins, peptides, lipids, nucleic acids, growth factors, hormones, and other substances. Exosomes derived from stem cells share similar functions with stem cells, including tissue repair and regeneration, enhancing the survival of transplanted fat, anti-inflammatory, and antioxidant effects. Compared to stem cells, exosomes are more stable, easier to preserve, manage, and control, and their content can be manipulated in terms of type and quantity. They lack live cells and have low immunogenicity. Research has found that stem cell-derived exosomes have various effects in anti-aging and medical aesthetics.
Melasma is an acquired pigmentation disorder predominantly affecting females. Its pathogenesis is complex, and treatment is challenging, making it one of the refractory skin diseases. Current treatment methods have long treatment cycles, high recurrence rates, and poor patient compliance, with treatment outcomes still not ideal. Recent studies show damage to the basement membrane in melasma skin lesions, and the regenerative repair function of stem cell-derived exosomes can repair the damaged basement membrane in these lesions, thus effectively treating melasma.
Due to the skin's barrier function, exosomes from stem cells can hardly penetrate the skin barrier. In recent years, various physicochemical methods such as chemical enhancers, nanotechnology, ultrasound, microneedles, radiofrequency, or thermal ablation have been introduced to facilitate the transdermal delivery of biologics. However, they pose significant issues in terms of skin irritation and damage while aiding in overcoming the skin barrier for effective enhancement. Therefore, finding methods that are minimally irritating to the skin and capable of facilitating the transdermal delivery of biologics remains a challenge in transdermal drug delivery.
This study aims to observe the therapeutic effect of umbilical cord mesenchymal stem cell-derived exosomes combined with 1565 non-ablative fractional laser treatment for melasma, validate the enhancement effect of 1565 non-ablative fractional laser, and explore a new combined treatment method for melasma that is effective, low in side effects, low in recurrence rate, and provides good patient comfort.
- Conditions
- Melasma
- Being tested
- Placebo Comparator:1565 non-ablative fractional laser combined with normal Saline, 1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell-derived exosomes.
- Keywords
- Melasma, stem cell, exosomes
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Comparator:1565 non-ablative fractional laser combined with normal SalineProcedure or surgery
Based on the patient's age, skin color, location of skin lesions, and Fitzpatrick skin type, adjust treatment parameters accordingly. The operator holds the treatment head, vertically applies parallel sweeps closely to the lesion area until the endpoint of slight skin redness is reached. After completion, apply normal Saline.
1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell-derived exosomes.Procedure or surgery
Based on the patient's age, skin color, location of skin lesions, and Fitzpatrick skin type, adjust treatment parameters accordingly. The operator holds the treatment head, vertically applies parallel sweeps closely to the lesion area until the endpoint of slight skin redness is reached. After completion, apply exosomes.
| Study group | Role | What they receive |
|---|---|---|
| 1565 non-ablative fractional laser combined with normal Saline | Placebo comparator | 1565 non-ablative fractional laser combined with normal Saline Receives: Procedure: Placebo Comparator:1565 non-ablative fractional laser combined with normal Saline |
| 1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell exosomes | Experimental | 1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell exosomes Receives: Procedure: 1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell-derived exosomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
melasma area and severity index, MASI
MASI = 0.3(DMR + HMR)AMR + 0.3(DF + HF)AF + 0.3(DML + HML)AML + 0.1(DC + HC)AC, The total score is 48 points, with lower scores indicating less severity of melasma. MASI is jointly assessed by two physicians from this department, taking the average value. If there is a significant difference in the evaluation results of the two physicians, a third physician from the same department will be consulted, and the average value of the two closest assessments will be taken.
Measured: 1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment
Secondary outcomes (3)
physician's global assessment, PGA
Based on the residual condition of pigmented lesions after treatment, a score of 0 to 6 is assigned: 0 points for complete clearance (100%) or only minimal residual pigmentation, 1 point for essentially cleared (≥ 90%), 2 points for marked improvement (75% ~ 89%), 3 points for moderate improvement (50% ~ 74%), 4 points for slight improvement (25% ~ 49%), 5 points for no improvement (< 25%), 6 points for worsening compared to before treatment.
Measured: 1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment
Patient satisfaction evaluation
Patient satisfaction is evaluated using a self-assessment satisfaction scale. It is divided into very satisfied (improvement ≥ 75%), satisfied (improvement 50% ~ 75%), average (improvement 25% ~ 49%), and dissatisfied (improvement ≤ 25%); Satisfaction rate = (Number of very satisfied cases + Number of satisfied cases) / Total number of cases × 100%.
Measured: 1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment
Occurrence of adverse reactions
Observation of adverse reactions including erythema, burning, itching, dryness, irritation, hyperpigmentation, edema, scar formation, skin breakdown, and skin infection.
Measured: 1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start28 Aug 2024
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
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.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChenXiaosong, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677931
- Sponsor's protocol ID
- 2024YF028-01
- Status last verified
- Jun 2025
- First submitted
- 5 Nov 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Melasma, a Prospective, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06677931
- Acronym / sponsor ID
- 2024YF028-01
- Conditions
- Melasma
- Keywords
- Melasma, stem cell, exosomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 7 Nov 2024 (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.
Melasma is a refractory skin disease with a complex pathogenesis and difficult treatment. Research has found that mesenchymal stem cell-derived exosomes have effects such as anti-wrinkle formation, anti-inflammation, antioxidant properties, skin whitening, and promotion of skin regeneration. Recent studies show that there is damage to the basement membrane in melasma skin lesions, and the regenerative repair function of mesenchymal stem cell-derived exosomes can repair the damaged basement membrane in melasma skin lesions, thereby effectively treating melasma. This study aims to observe the therapeutic effect of umbilical cord mesenchymal stem cell-derived exosomes combined with 1565 non-ablative fractional laser treatment for melasma, verify the enhancement effect of 1565 non-ablative fractional laser, and also explore a new combined treatment method for melasma that is effective, low in side effects, low in recurrence rate, and provides good patient comfort.
Detailed description
Exosomes are small, uniform lipid bilayer vesicles with a molecular diameter of 30-150 nanometers, formed by cells and actively secreted into the extracellular space. They contain proteins, peptides, lipids, nucleic acids, growth factors, hormones, and other substances. Exosomes derived from stem cells share similar functions with stem cells, including tissue repair and regeneration, enhancing the survival of transplanted fat, anti-inflammatory, and antioxidant effects. Compared to stem cells, exosomes are more stable, easier to preserve, manage, and control, and their content can be manipulated in terms of type and quantity. They lack live cells and have low immunogenicity. Research has found that stem cell-derived exosomes have various effects in anti-aging and medical aesthetics.
Melasma is an acquired pigmentation disorder predominantly affecting females. Its pathogenesis is complex, and treatment is challenging, making it one of the refractory skin diseases. Current treatment methods have long treatment cycles, high recurrence rates, and poor patient compliance, with treatment outcomes still not ideal. Recent studies show damage to the basement membrane in melasma skin lesions, and the regenerative repair function of stem cell-derived exosomes can repair the damaged basement membrane in these lesions, thus effectively treating melasma.
Due to the skin's barrier function, exosomes from stem cells can hardly penetrate the skin barrier. In recent years, various physicochemical methods such as chemical enhancers, nanotechnology, ultrasound, microneedles, radiofrequency, or thermal ablation have been introduced to facilitate the transdermal delivery of biologics. However, they pose significant issues in terms of skin irritation and damage while aiding in overcoming the skin barrier for effective enhancement. Therefore, finding methods that are minimally irritating to the skin and capable of facilitating the transdermal delivery of biologics remains a challenge in transdermal drug delivery.
This study aims to observe the therapeutic effect of umbilical cord mesenchymal stem cell-derived exosomes combined with 1565 non-ablative fractional laser treatment for melasma, validate the enhancement effect of 1565 non-ablative fractional laser, and explore a new combined treatment method for melasma that is effective, low in side effects, low in recurrence rate, and provides good patient comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1565 non-ablative fractional laser combined with normal Saline | Placebo comparator | Procedure: Placebo Comparator:1565 non-ablative fractional laser combined with normal Saline1565 non-ablative fractional laser combined with normal Saline |
| 1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell exosomes | Experimental | Procedure: 1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell-derived exosomes.1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell exosomes |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 60 years with good overall health.
- Diagnosed with melasma according to clinical diagnostic criteria and efficacy standards (revised edition), with facial skin lesions.
- Fully understands and comprehends the content and significance of the study, implementation plan, potential benefits, risks, mitigation measures, participant rights and obligations (including privacy protection and voluntary withdrawal), and willingly signs the informed consent form to participate in the clinical study, and can cooperate well.
- Exclusion of inflammatory post-pigmentary disorders, malar melasma, Riehl's melanosis, pigmentary lichenoid dermatosis, and other skin diseases.
- Agrees not to use other cosmetic treatments related to the study during the research period.
Key exclusion criteria (14 listed)
- Patients who refuse to sign the informed consent form to participate in the trial.
- History of significant organ diseases, autoimmune diseases, or immune dysfunction.
- Abnormal coagulation function, current use of anticoagulants, tendency for thrombosis, or family history of genetic diseases.
- Pregnant or lactating women.
- Patients who have taken oral contraceptives or hormone replacement therapy during the study period or in the past 12 months.
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 |
|---|---|---|
| Placebo Comparator:1565 non-ablative fractional laser combined with normal SalineBased on the patient's age, skin color, location of skin lesions, and Fitzpatrick skin type, adjust treatment parameters accordingly. The operator holds the treatment head, vertically applies parallel sweeps closely to the lesion area until the endpoint of slight skin redness is reached. After completion, apply normal Saline. | Procedure or surgery | 1565 non-ablative fractional laser combined with normal Saline |
| 1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell-derived exosomes.Based on the patient's age, skin color, location of skin lesions, and Fitzpatrick skin type, adjust treatment parameters accordingly. The operator holds the treatment head, vertically applies parallel sweeps closely to the lesion area until the endpoint of slight skin redness is reached. After completion, apply exosomes. | Procedure or surgery | 1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell exosomes |
Primary outcome
melasma area and severity index, MASI
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment
MASI = 0.3(DMR + HMR)AMR + 0.3(DF + HF)AF + 0.3(DML + HML)AML + 0.1(DC + HC)AC, The total score is 48 points, with lower scores indicating less severity of melasma. MASI is jointly assessed by two physicians from this department, taking the average value. If there is a significant difference in the evaluation results of the two physicians, a third physician from the same department will be consulted, and the average value of the two closest assessments will be taken.
3 secondary outcomes
physician's global assessment, PGA
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment
Patient satisfaction evaluation
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment
Occurrence of adverse reactions
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell-derived exosomes. in people with Melasma, run by Fujian Medical University Union Hospital at 2 sites in China.
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 14 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: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
melasma area and severity index, MASI (time frame: 1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment). 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 22 Jan 2026.