Skin AgingPhase 4EFSATAEMDNCT07372001
Effects on Facial Skin Aging After Topical Application of Exosomes With a Microneedling Device
A Phase 4 study testing Topical lyophilized exosomes application in people with Skin Aging, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial summary
In this study, we evaluated the extent of reversal of facial dermal aging signs using topical lyophilized exosomes with a microneedling device Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Skin Aging
- What is being tested?
- Topical lyophilized exosomes application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2024to 1 Mar 2025
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over the age of 50 with facial rhytides and a minimum score of 12 on the SASSQ scale
Who cannot join
- pregnancy or breastfeeding, active acne or rosacea, local infections, lesions suspicious for malignancy, and allergy to exosomes. The elimination criteria involved loss of follow-up of the research subject and the occurrence of an allergic reaction or intolerable adverse effects.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto de Oftalmología F.A.P. Conde de Valenciana, I.A.P.
Mexico City, Mexico City, 08800
About this study
In this study, we evaluated the extent of reversal of facial dermal aging signs using topical lyophilized exosomes with a microneedling device
Read the detailed description
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.
- Conditions
- Skin Aging
- Being tested
- Topical lyophilized exosomes application
- Keywords
- Exosomes., Skin, Skin Aging, Rejuvenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical lyophilized exosomes applicationBiological
Also called Exosomes
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Topical lyophilized exosomes application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial dermal changes
Six skin characteristics were evaluated using SASSQ visual scale: elasticity, wrinkles, roughness, pigmentation, erythema, and pore size
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Jul 2024
- Primary completion1 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Skin AgingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This was a clinical, experimental, prospective, and comparative investigation conducted in a before-and-after format
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372001
- Sponsor's protocol ID
- CEI-2024/04/02
- Acronym
- EFSATAEMD
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
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
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.
PubMed 8532986Alzahrani 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.
PubMed 31217862Shin KO, Ha DH, Kim JO, Crumrine DA, Meyer JM, Wakefield JS, Lee Y, Kim B, Kim S, Kim HK, Lee J, Kwon HH, Park GH, Lee JH, Lim J, Park S, Elias PM, Park K, Yi YW, Cho BS. Exosomes from Human Adipose Tissue-Derived Mesenchymal Stem Cells Promote Epidermal Barrier Repair by Inducing de Novo Synthesis of Ceramides in Atopic Dermatitis. Cells. 2020 Mar 10;9(3):680. doi: 10.3390/cells9030680.
PubMed 32164386Hu S, Li Z, Cores J, Huang K, Su T, Dinh PU, Cheng K. Needle-Free Injection of Exosomes Derived from Human Dermal Fibroblast Spheroids Ameliorates Skin Photoaging. ACS Nano. 2019 Oct 22;13(10):11273-11282. doi: 10.1021/acsnano.9b04384. Epub 2019 Aug 26.
PubMed 31449388Liu M, Wang H, Liu Z, Liu G, Wang W, Li X. Exosomes from adipose-derived stem cells inhibits skin cancer progression via miR-199a-5p/SOX4. Biotechnol Genet Eng Rev. 2024 Dec;40(4):3950-3962. doi: 10.1080/02648725.2023.2204702. Epub 2023 Apr 24.
PubMed 37092869Lueangarun S, Cho BS, Tempark T. Topical moisturizer with rose stem cell-derived exosomes (RSCEs) for recalcitrant seborrheic dermatitis: A case report with 6 months of follow-up. J Cosmet Dermatol. 2024 Oct;23(10):3128-3132. doi: 10.1111/jocd.16389. Epub 2024 Jun 3.
PubMed 38831604Hade MD, Suire CN, Suo Z. Mesenchymal Stem Cell-Derived Exosomes: Applications in Regenerative Medicine. Cells. 2021 Aug 1;10(8):1959. doi: 10.3390/cells10081959.
PubMed 34440728Ha DH, Kim HK, Lee J, Kwon HH, Park GH, Yang SH, Jung JY, Choi H, Lee JH, Sung S, Yi YW, Cho BS. Mesenchymal Stem/Stromal Cell-Derived Exosomes for Immunomodulatory Therapeutics and Skin Regeneration. Cells. 2020 May 7;9(5):1157. doi: 10.3390/cells9051157.
PubMed 32392899Ma J, Yong L, Lei P, Li H, Fang Y, Wang L, Chen H, Zhou Q, Wu W, Jin L, Sun D, Zhang X. Advances in microRNA from adipose-derived mesenchymal stem cell-derived exosome: focusing on wound healing. J Mater Chem B. 2022 Nov 30;10(46):9565-9577. doi: 10.1039/d2tb01987f.
PubMed 36398750Ottenhof MJ, Veldhuizen IJ, Hensbergen LJV, Blankensteijn LL, Bramer W, Lei BV, Hoogbergen MM, Hulst RRWJ, Sidey-Gibbons CJ. The Use of the FACE-Q Aesthetic: A Narrative Review. Aesthetic Plast Surg. 2022 Dec;46(6):2769-2780. doi: 10.1007/s00266-022-02974-9. Epub 2022 Jun 28.
PubMed 35764813Eiben-Nielson C, Kerscher M. Development and validation of a global photonumeric scale for evaluating skin quality of aged female facial skin. J Cosmet Dermatol. 2021 Dec;20(12):4032-4039. doi: 10.1111/jocd.14058. Epub 2021 Mar 24.
PubMed 33690945Rorteau J, Chevalier FP, Fromy B, Lamartine J. [Functional integrity of aging skin, from cutaneous biology to anti-aging strategies]. Med Sci (Paris). 2020 Dec;36(12):1155-1162. doi: 10.1051/medsci/2020223. Epub 2020 Dec 9. French.
PubMed 33296632Csekes E, Rackova L. Skin Aging, Cellular Senescence and Natural Polyphenols. Int J Mol Sci. 2021 Nov 23;22(23):12641. doi: 10.3390/ijms222312641.
PubMed 34884444Kanitakis J. Anatomy, histology and immunohistochemistry of normal human skin. Eur J Dermatol. 2002 Jul-Aug;12(4):390-9; quiz 400-1.
PubMed 12095893
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Facial Skin Aging After Topical Application of Exosomes With a Microneedling Device
- ClinicalTrials.gov ID
- NCT07372001
- Acronym / sponsor ID
- EFSATAEMD / CEI-2024/04/02
- Conditions
- Skin Aging
- Keywords
- Exosomes., Skin, Skin Aging, Rejuvenation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 28 Jan 2026 (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.
In this study, we evaluated the extent of reversal of facial dermal aging signs using topical lyophilized exosomes with a microneedling device
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was a clinical, experimental, prospective, and comparative investigation conducted in a before-and-after format
| Arm | Type | Receives |
|---|---|---|
| Topical lyophilized exosomes application | Other | Biological: Topical lyophilized exosomes applicationThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women over the age of 50 with facial rhytides and a minimum score of 12 on the SASSQ scale
Key exclusion criteria (1 listed)
- pregnancy or breastfeeding, active acne or rosacea, local infections, lesions suspicious for malignancy, and allergy to exosomes. The elimination criteria involved loss of follow-up of the research subject and the occurrence of an allergic reaction or intolerable adverse effects.
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 |
|---|---|---|
| Topical lyophilized exosomes applicationAlso: ExosomesThe 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 | Biological | Topical lyophilized exosomes application |
Primary outcome
Facial dermal changes
Time frame: From enrollment to the end of treatment at 8 weeks
Six skin characteristics were evaluated using SASSQ visual scale: elasticity, wrinkles, roughness, pigmentation, erythema, and pore size
Subjective evaluation of facial dermal changes
Time frame: From enrollment to the end of treatment at 8 weeks
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.
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 28 Jan 2026.
- Results publicationKieser 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
- Results publication: PubMed 8532986Browne 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.
- Results publication: PubMed 31217862Alzahrani 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.
- Results publication: PubMed 32164386Shin KO, Ha DH, Kim JO, Crumrine DA, Meyer JM, Wakefield JS, Lee Y, Kim B, Kim S, Kim HK, Lee J, Kwon HH, Park GH, Lee JH, Lim J, Park S, Elias PM, Park K, Yi YW, Cho BS. Exosomes from Human Adipose Tissue-Derived Mesenchymal Stem Cells Promote Epidermal Barrier Repair by Inducing de Novo Synthesis of Ceramides in Atopic Dermatitis. Cells. 2020 Mar 10;9(3):680. doi: 10.3390/cells9030680.
- Results publication: PubMed 31449388Hu S, Li Z, Cores J, Huang K, Su T, Dinh PU, Cheng K. Needle-Free Injection of Exosomes Derived from Human Dermal Fibroblast Spheroids Ameliorates Skin Photoaging. ACS Nano. 2019 Oct 22;13(10):11273-11282. doi: 10.1021/acsnano.9b04384. Epub 2019 Aug 26.
- Results publication: PubMed 37092869Liu M, Wang H, Liu Z, Liu G, Wang W, Li X. Exosomes from adipose-derived stem cells inhibits skin cancer progression via miR-199a-5p/SOX4. Biotechnol Genet Eng Rev. 2024 Dec;40(4):3950-3962. doi: 10.1080/02648725.2023.2204702. Epub 2023 Apr 24.
- Results publication: PubMed 38831604Lueangarun S, Cho BS, Tempark T. Topical moisturizer with rose stem cell-derived exosomes (RSCEs) for recalcitrant seborrheic dermatitis: A case report with 6 months of follow-up. J Cosmet Dermatol. 2024 Oct;23(10):3128-3132. doi: 10.1111/jocd.16389. Epub 2024 Jun 3.
- Results publication: PubMed 34440728Hade MD, Suire CN, Suo Z. Mesenchymal Stem Cell-Derived Exosomes: Applications in Regenerative Medicine. Cells. 2021 Aug 1;10(8):1959. doi: 10.3390/cells10081959.
- Results publication: PubMed 32392899Ha DH, Kim HK, Lee J, Kwon HH, Park GH, Yang SH, Jung JY, Choi H, Lee JH, Sung S, Yi YW, Cho BS. Mesenchymal Stem/Stromal Cell-Derived Exosomes for Immunomodulatory Therapeutics and Skin Regeneration. Cells. 2020 May 7;9(5):1157. doi: 10.3390/cells9051157.
- Results publication: PubMed 36398750Ma J, Yong L, Lei P, Li H, Fang Y, Wang L, Chen H, Zhou Q, Wu W, Jin L, Sun D, Zhang X. Advances in microRNA from adipose-derived mesenchymal stem cell-derived exosome: focusing on wound healing. J Mater Chem B. 2022 Nov 30;10(46):9565-9577. doi: 10.1039/d2tb01987f.
- Results publication: PubMed 35764813Ottenhof MJ, Veldhuizen IJ, Hensbergen LJV, Blankensteijn LL, Bramer W, Lei BV, Hoogbergen MM, Hulst RRWJ, Sidey-Gibbons CJ. The Use of the FACE-Q Aesthetic: A Narrative Review. Aesthetic Plast Surg. 2022 Dec;46(6):2769-2780. doi: 10.1007/s00266-022-02974-9. Epub 2022 Jun 28.
- Results publication: PubMed 33690945Eiben-Nielson C, Kerscher M. Development and validation of a global photonumeric scale for evaluating skin quality of aged female facial skin. J Cosmet Dermatol. 2021 Dec;20(12):4032-4039. doi: 10.1111/jocd.14058. Epub 2021 Mar 24.
- Individual participant dataSharing planned: Yes. All collected IPD
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical lyophilized exosomes application in people with Skin Aging, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
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 1 inclusion and 1 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 28 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 1 site in Mexico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Facial dermal changes (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07372001, which also lists 15 linked publications.
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 28 Jan 2026.