Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration

ConditionMelasma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFujian Medical University Union Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 1565 nm non-ablative fractional laser combined with normal saline

    Procedure/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-Exos

    Procedure/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-Exos

    Procedure/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-Exos

    Procedure/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.

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: 1565 nm non-ablative fractional laser combined with normal salinePlacebo comparator 1 intervention
Group B: microneedles combined with hUCMSC-ExosExperimental treatment 1 intervention
Group C: 1565 nm non-ablative fractional laser combined with hUCMSC-ExosExperimental treatment 1 intervention
Group D: PBASM combined with hUCMSC-ExosExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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