MelasmaNCT06221787
Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration
A study testing 1565 nm non-ablative fractional laser combined with normal saline, microneedles combined with hUCMSC-Exos and 1565 nm non-ablative fractional laser combined with hUCMSC-Exos in people with Melasma, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
Melasma is a refractory skin disease due to its complex pathogenesis and difficult treatment. Studies have found that human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) could serve as a novel cell-free therapeutic strategy in regenerative and aesthetic medicine. 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 nm non-ablative fractional laser combined with normal saline, microneedles combined with hUCMSC-Exos and 1565 nm non-ablative fractional laser combined with hUCMSC-Exos
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Jul 2026
- 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
- Patients diagnosed with chloasma who meet the clinical diagnostic standards and efficacy standards (revised version) of chloasma and have skin lesions on the face.
- It is hoped that exosomes combined with 1565 non-ablative fractional laser, blue aurora or micro-needle can improve facial chloasma.
- Fully understand and understand the content and significance of this study, implementation plan, possible benefits, risks and countermeasures, rights and obligations of subjects (including privacy protection, free withdrawal), willing to participate in this clinical study and able to cooperate well, Those who signed the informed consent form.
- Exclude post-inflammatory pigmentation, malar brown-green nevus, Riehl's melanosis, pigmented lichen planus and other skin diseases.
- Subjects who agree not to use other cosmetic treatments related to the study during the study period.
Who cannot join
- Patients who refuse to sign the informed consent form to participate in the trial;
- Those with a history of important organ diseases, or a history of autoimmune diseases or immune dysfunction;
- Abnormal coagulation function, current use of anticoagulants, thrombophilia and history of familial genetic diseases;
- Pregnant or lactating women;
- Patients taking oral contraceptives or hormone replacement therapy during the study period or within the past 12 months;
- Patients with scar constitution;
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- Active skin infection;
- Those who have a history of multiple severe allergies, a history of hereditary allergies, photosensitivity or photosensitivity drugs, such as sulfa drugs and tetracyclines, those who are allergic to local anesthetics and those who are allergic to lidocaine components, and those who plan to undergo detoxification during the study Allergy healer;
- History of post-inflammatory pigmentation;
- Those who have received treatment for chloasma in the past;
- Those who have undergone chemical peeling, dermabrasion or other skin resurfacing on their face in the past;
- Patients who are participating in other clinical studies;
- Other reasons that the researcher considers unsuitable for clinical investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, 350001
About this study
Melasma is a refractory skin disease due to its complex pathogenesis and difficult treatment. Studies have found that human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) could serve as a novel cell-free therapeutic strategy in regenerative and aesthetic medicine. It could potentially treat melasma, but the skin barrier is a challenge. This study aims to explore the safety and efficacy of hUCMSC-Exos in the treatment of melasma and means to promote its percutaneous penetration.
Read the detailed description
80 patients with melasma treated in our department were divided into four groups. 1565 nm nonablative fractional laser (NAFL) combined with normal saline treatment group was used for Group A. Microneedle，NAFL，a plasma named Peninsula Blue Aurora Shumin Master (PBASM) combined with hUCMSC-Exos were used for the other treatment groups (B, C, and D, respectively). The treatment was given four times with an interval of one month. The degree of pain post-treatment, MASI, improvement rate, physician global assessment score, satisfaction and complications after treatment were evaluated six months later.
- Conditions
- Melasma
- Being tested
- 1565 nm non-ablative fractional laser combined with normal saline, microneedles combined with hUCMSC-Exos, 1565 nm non-ablative fractional laser combined with hUCMSC-Exos, PBASM combined with hUCMSC-Exos
- Keywords
- Melasma, Stem cell-derived exosomes, Percutaneous Penetration
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1565 nm non-ablative fractional laser combined with normal salineProcedure or surgery
After 1565 nm non-ablative fractional laser treatment, patients with melasma were smeared with normal saline and to compared with those smeared with exosomes after laser treatment.
microneedles combined with hUCMSC-ExosProcedure or surgery
the hUCMSC-Exos were applied while rolling a microneedle roller and to compared with those used 1565 nm non-ablative fractional laser or PBASM combined with hUCMSC-Exos.
1565 nm non-ablative fractional laser combined with hUCMSC-ExosProcedure or surgery
After 1565 nm non-ablative fractional laser treatment, patients with melasma were smeared with hUCMSC-Exos and to compared with those smeared with normal saline after laser treatment.What's more,compared with those used microneedles or PBASM combined with hUCMSC-Exos.
PBASM combined with hUCMSC-ExosProcedure or surgery
a plasma named Peninsula Blue Aurora Shumin Master (PBASM) rolling each area for 8-10 min before applying the hUCMSC-Exos in the entire face. And to compared with those used 1565 nm non-ablative fractional laser or microneedles combined with hUCMSC-Exos.
| Study group | Role | What they receive |
|---|---|---|
| 1565 nm non-ablative fractional laser combined with normal saline | Placebo comparator | The treatment parameters were adjusted according to each patient's age, skin color, surface area of affected skin, location of melasma, and skin type.After the scanning, infusing with normal saline in the entire face. Receives: Procedure: 1565 nm non-ablative fractional laser combined with normal saline |
| microneedles combined with hUCMSC-Exos | Experimental | The hUCMSC-Exos were applied while rolling a microneedle roller in the entire face. Receives: Procedure: microneedles combined with hUCMSC-Exos |
| 1565 nm non-ablative fractional laser combined with hUCMSC-Exos | Experimental | The treatment parameters were adjusted according to each patient's age, skin color, surface area of affected skin, location of melasma, and skin type.After the scanning, infusing with hUCMSC-Exos in the entire face. Receives: Procedure: 1565 nm non-ablative fractional laser combined with hUCMSC-Exos |
| PBASM combined with hUCMSC-Exos | Experimental | 4-5 levels of intensity were used, rolling each area for 8-10 min before applying the hUCMSC-Exos in the entire face. Receives: Procedure: PBASM combined with hUCMSC-Exos |
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, A is the area proportion of chloasma, D is the color depth of the spots, H is the color uniformity, F is the forehead; ML is the left cheek; MR is the right cheek; C is the mandible. Scores for color depth and color uniformity of stains: total score is 4 points each, and the color degree of stains is 0 (no deepening), 1 (slightly deepened), 2 (moderately deepened), 3 (obviously deepened), 4 points (severely deepened); color uniformity is 0 points (extremely inconsistent), 1 point (slightly consistent), 2 points (moderately consistent), 3 points (obviously consistent), 4 points (almost completely consistent); damage Area proportion score: total score is 6 points, 0 is normal, 1 is <10%, 2 is 10%~29%, 3 is 30%~49%, 4 is 50%~69%, 5 It is divided into 70% to 89% and 6 points to 90% to 100%. The total score is 48 points, and the lower the score, the less serious the chloasma.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Apr 2022
- Primary completion1 Aug 2025
- Study completion1 Jul 2026
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
- 80 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
- Investigators
- xiaosong chen, director, Study chair, Affiliated Union Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221787
- Sponsor's protocol ID
- 2020KY0155
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2024
- Last updated
- 3 Sep 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration
- ClinicalTrials.gov ID
- NCT06221787
- Acronym / sponsor ID
- 2020KY0155
- Conditions
- Melasma
- Keywords
- Melasma, Stem cell-derived exosomes, Percutaneous Penetration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 24 Jan 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 due to its complex pathogenesis and difficult treatment. Studies have found that human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) could serve as a novel cell-free therapeutic strategy in regenerative and aesthetic medicine. It could potentially treat melasma, but the skin barrier is a challenge. This study aims to explore the safety and efficacy of hUCMSC-Exos in the treatment of melasma and means to promote its percutaneous penetration.
Detailed description
80 patients with melasma treated in our department were divided into four groups. 1565 nm nonablative fractional laser (NAFL) combined with normal saline treatment group was used for Group A. Microneedle，NAFL，a plasma named Peninsula Blue Aurora Shumin Master (PBASM) combined with hUCMSC-Exos were used for the other treatment groups (B, C, and D, respectively). The treatment was given four times with an interval of one month. The degree of pain post-treatment, MASI, improvement rate, physician global assessment score, satisfaction and complications after treatment were evaluated six months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1565 nm non-ablative fractional laser combined with normal saline | Placebo comparator | Procedure: 1565 nm non-ablative fractional laser combined with normal salineThe treatment parameters were adjusted according to each patient's age, skin color, surface area of affected skin, location of melasma, and skin type.After the scanning, infusing with normal saline in the entire face. |
| microneedles combined with hUCMSC-Exos | Experimental | Procedure: microneedles combined with hUCMSC-ExosThe hUCMSC-Exos were applied while rolling a microneedle roller in the entire face. |
| 1565 nm non-ablative fractional laser combined with hUCMSC-Exos | Experimental | Procedure: 1565 nm non-ablative fractional laser combined with hUCMSC-ExosThe treatment parameters were adjusted according to each patient's age, skin color, surface area of affected skin, location of melasma, and skin type.After the scanning, infusing with hUCMSC-Exos in the entire face. |
| PBASM combined with hUCMSC-Exos | Experimental | Procedure: PBASM combined with hUCMSC-Exos4-5 levels of intensity were used, rolling each area for 8-10 min before applying the hUCMSC-Exos in the entire face. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients diagnosed with chloasma who meet the clinical diagnostic standards and efficacy standards (revised version) of chloasma and have skin lesions on the face.
- It is hoped that exosomes combined with 1565 non-ablative fractional laser, blue aurora or micro-needle can improve facial chloasma.
- Fully understand and understand the content and significance of this study, implementation plan, possible benefits, risks and countermeasures, rights and obligations of subjects (including privacy protection, free withdrawal), willing to participate in this clinical study and able to cooperate well, Those who signed the informed consent form.
- Exclude post-inflammatory pigmentation, malar brown-green nevus, Riehl's melanosis, pigmented lichen planus and other skin diseases.
- Subjects who agree not to use other cosmetic treatments related to the study during the study period.
Key exclusion criteria (13 listed)
- Patients who refuse to sign the informed consent form to participate in the trial;
- Those with a history of important organ diseases, or a history of autoimmune diseases or immune dysfunction;
- Abnormal coagulation function, current use of anticoagulants, thrombophilia and history of familial genetic diseases;
- Pregnant or lactating women;
- Patients taking oral contraceptives or hormone replacement therapy during the study period or within 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 |
|---|---|---|
| 1565 nm non-ablative fractional laser combined with normal salineAfter 1565 nm non-ablative fractional laser treatment, patients with melasma were smeared with normal saline and to compared with those smeared with exosomes after laser treatment. | Procedure or surgery | 1565 nm non-ablative fractional laser combined with normal saline |
| microneedles combined with hUCMSC-Exosthe hUCMSC-Exos were applied while rolling a microneedle roller and to compared with those used 1565 nm non-ablative fractional laser or PBASM combined with hUCMSC-Exos. | Procedure or surgery | microneedles combined with hUCMSC-Exos |
| 1565 nm non-ablative fractional laser combined with hUCMSC-ExosAfter 1565 nm non-ablative fractional laser treatment, patients with melasma were smeared with hUCMSC-Exos and to compared with those smeared with normal saline after laser treatment.What's more,compared with those used microneedles or PBASM combined with hUCMSC-Exos. | Procedure or surgery | 1565 nm non-ablative fractional laser combined with hUCMSC-Exos |
| PBASM combined with hUCMSC-Exosa plasma named Peninsula Blue Aurora Shumin Master (PBASM) rolling each area for 8-10 min before applying the hUCMSC-Exos in the entire face. And to compared with those used 1565 nm non-ablative fractional laser or microneedles combined with hUCMSC-Exos. | Procedure or surgery | PBASM combined with hUCMSC-Exos |
Primary outcome
melasma area and severity index （MASI）
Time frame: 6 months
MASI=0.3(DMR+HMR)AMR+0.3(DF+HF)AF+0.3(DML+HML)AML+0.1(DC+HC)AC, A is the area proportion of chloasma, D is the color depth of the spots, H is the color uniformity, F is the forehead; ML is the left cheek; MR is the right cheek; C is the mandible. Scores for color depth and color uniformity of stains: total score is 4 points each, and the color degree of stains is 0 (no deepening), 1 (slightly deepened), 2 (moderately deepened), 3 (obviously deepened), 4 points (severely deepened); color uniformity is 0 points (extremely inconsistent), 1 point (slightly consistent), 2 points (moderately consistent), 3 points (obviously consistent), 4 points (almost completely consistent); damage Area proportion score: total score is 6 points, 0 is normal, 1 is <10%, 2 is 10%~29%, 3 is 30%~49%, 4 is 50%~69%, 5 It is divided into 70% to 89% and 6 points to 90% to 100%. The total score is 48 points, and the lower the score, the less serious the chloasma.
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 3 Sep 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.
xiaosong chen, director study chair
Affiliated Union Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1565 nm non-ablative fractional laser combined with normal saline, microneedles combined with hUCMSC-Exos and 1565 nm non-ablative fractional laser combined with hUCMSC-Exos in people with Melasma, run by Fujian Medical University Union Hospital at 1 site 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 13 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 3 Sep 2026. 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 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: 6 months). 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 3 Sep 2026.