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In this study, we evaluated the extent of reversal of facial dermal aging signs using topical lyophilized exosomes with a microneedling device
This clinical, experimental, prospective, and comparative investigation was conducted in a before-and-after format. The exosomes were applied to the facial area by dripping onto the skin and using a microneedling device to enhance dermal penetration. Three sessions, each four weeks apart, were performed for each subject. During each session, documentation was performed using photographs and the SAASQ and FaceQ visual scales for objective and subjective evaluations, respectively. ANOVA test for repeated measures was used for the statistical analysis. SPSS version 31.0 was used for the analysis.
All measured variables, both objective and subjective, were favorable for the use of exosomes as a treatment for early signs of aging.
This pilot study provides preliminary results showing an excellent cosmetic response to exosome treatment using microneedling, with good user satisfaction and tolerable and harmless adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical lyophilized exosomes application | Other | The exosomes were applied to the facial area by dripping onto the skin and using a microneedling device to enhance dermal penetration. Three sessions, each four weeks apart, were performed for each subject. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical lyophilized exosomes application | Biological | The exosomes were applied to the facial area by dripping onto the skin and using a microneedling device to enhance dermal penetration. Three sessions, each four weeks apart, were performed for each subject |
| Measure | Description | Time Frame |
|---|---|---|
| Facial dermal changes | Six skin characteristics were evaluated using SASSQ visual scale: elasticity, wrinkles, roughness, pigmentation, erythema, and pore size | From enrollment to the end of treatment at 8 weeks |
| Subjective evaluation of facial dermal changes | The FACE-Q Aesthetics questionnaire was utilized, comprising 37 independent functional scales and six checklists that measure patient-relevant outcomes from their perspective. In this study, the following scales from this questionnaire were used: expectations (before), satisfaction with skin (before and after), psychosocial distress related to appearance (before and after), assessment of facial lines: general impression (before and after), and satisfaction with the decision (after). Additionally, an adverse effects scale was used. | From enrollment to the end of treatment at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de OftalmologÃa F.A.P. Conde de Valenciana, I.A.P. | Mexico City | Mexico City | 08800 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Kieser M, Wassmer G. On the use of the upper confidence limit for the variance from a pilot sample for sample size determination. Biom J. 1996;38(8):941-9. doi: 10.1002/bimj.4710380806 | ||
| 8532986 | Result | Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. doi: 10.1002/sim.4780141709. | |
| 31217862 |
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All collected IPD
March 2026 - June 2026
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This was a clinical, experimental, prospective, and comparative investigation conducted in a before-and-after format
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| Result |
| Alzahrani FA. Melatonin improves therapeutic potential of mesenchymal stem cells-derived exosomes against renal ischemia-reperfusion injury in rats. Am J Transl Res. 2019 May 15;11(5):2887-2907. eCollection 2019. |
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