ExosomeNCT06279039
Clinical Observation of Exosomes in Patients After Q-switched Laser Surgery
A study testing Exosome liquid dressing in people with Exosome and Skin Regeneration, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
the goal of this half-face controlled study is to evaluate the effect of exosome-containing liquid dressings on the recovery of patients after Nd:YAG laser 532 treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Exosome, Skin Regeneration, Laser
- What is being tested?
- Exosome liquid dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2024
- 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
- It meets the diagnostic criteria of seborrheic keratosis or freckle；
- pepole are able to follow the treatment rules of the study and were followed up for 8 weeks；
- informed consent
Who cannot join
- History of keloids ;
- Pregnancy or lactation;
- Any cosmetics containing growth factor-related ingredients used within 6 months prior to treatment
- Patients with incomplete observation data and incomplete course of treatment were excluded
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jie Dai
Nanjing, Jiangsu, 210006
jie dai, 02552271117, karry_dj@126.com
About this study
the goal of this half-face controlled study is to evaluate the effect of exosome-containing liquid dressings on the recovery of patients after Nd:YAG laser 532 treatment.
Read the detailed description
The main objective was to collect patients with fleae or seborrheic keratosis after Q-switched laser treatment, and then to use exosomes or matrix on both sides of the face, and finally to evaluate the effect of exosomes on wound healing and prevention of post-inflammatory hyperpigmentation after Nd:YAG laser 532 treatment
- Conditions
- Exosome, Skin Regeneration, Laser
- Being tested
- Exosome liquid dressing
- Keywords
- Exosome, Q-switched laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosome liquid dressingDrug
Also called follow
This study mainly adopted a randomized double-blind self-half face control method. The double-blind method was that the subjects and researchers did not know the experimental group and the control group. 38 sets of matched use sets (left and right, only the manufacturer knew the specific ingredients) were respectively applied to both sides of the cheeks of patients after Q-switched laser. The blind was unblinded after the experiment.
| Study group | Role | What they receive |
|---|---|---|
| self half face control method | Experimental | One side of the face was treated with exosome liquid dressing twice a day, and the other side was treated without exosome matrix for 2 weeks. The patients were followed up before treatment and 1, 3，7, 14, 28, and 56 days after treatment Receives: Drug: Exosome liquid dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Aesthetic Improvement Scale score
The treating physician evaluated the patient's improvement, which was divided into four levels: very improved corresponding, substantial improvement, improvement, no change; Corresponding to the best beauty results, significantly improved but not the best, significantly improved, no change
Measured: 1, 3.5, 7, 14, 28, and 56 days
Dermatology Quality of life index
By answering multiple questions, patients self-rated the impact of their current illness on their lives within a week and scored. The answers were graded on four levels, very serious 3, very serious 2, a little 1, and no 0
Measured: 1, 3.5, 7, 14, 28, and 56 days
Secondary outcomes (1)
post-inflammatory hyperpigmentation
At 2, 4 and 8 weeks of follow-up, melanin index was measured by memetreter (memetreter MX18 cuttometer Dual MPA580, EnviroDerm Services (UK) Ltd) at the same follow-up. Objective evaluation of PIH.
Measured: 2.4,8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Sep 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ExosomeStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dai jie, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Jie Dai, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279039
- Sponsor's protocol ID
- KY20230116-06
- Status last verified
- Feb 2024
- First submitted
- 6 Apr 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polla LL, Margolis RJ, Dover JS, Whitaker D, Murphy GF, Jacques SL, Anderson RR. Melanosomes are a primary target of Q-switched ruby laser irradiation in guinea pig skin. J Invest Dermatol. 1987 Sep;89(3):281-6. doi: 10.1111/1523-1747.ep12471397.
PubMed 3624901Aurangabadkar SJ. Optimizing Q-switched lasers for melasma and acquired dermal melanoses. Indian J Dermatol Venereol Leprol. 2019 Jan-Feb;85(1):10-17. doi: 10.4103/ijdvl.IJDVL_1086_16.
PubMed 30027914Kilmer SL, Wheeland RG, Goldberg DJ, Anderson RR. Treatment of epidermal pigmented lesions with the frequency-doubled Q-switched Nd:YAG laser. A controlled, single-impact, dose-response, multicenter trial. Arch Dermatol. 1994 Dec;130(12):1515-9.
PubMed 7986124Zoumalan CI. Topical Agents for Scar Management: Are They Effective? J Drugs Dermatol. 2018 Apr 1;17(4):421-425.
PubMed 29601619Stadelmann WK, Digenis AG, Tobin GR. Physiology and healing dynamics of chronic cutaneous wounds. Am J Surg. 1998 Aug;176(2A Suppl):26S-38S. doi: 10.1016/s0002-9610(98)00183-4.
PubMed 9777970Midwood KS, Williams LV, Schwarzbauer JE. Tissue repair and the dynamics of the extracellular matrix. Int J Biochem Cell Biol. 2004 Jun;36(6):1031-7. doi: 10.1016/j.biocel.2003.12.003.
PubMed 15094118Theoret CL. The pathophysiology of wound repair. Vet Clin North Am Equine Pract. 2005 Apr;21(1):1-13. doi: 10.1016/j.cveq.2004.11.001.
PubMed 15691596Toyserkani NM, Christensen ML, Sheikh SP, Sorensen JA. Adipose-Derived Stem Cells: New Treatment for Wound Healing? Ann Plast Surg. 2015 Jul;75(1):117-23. doi: 10.1097/SAP.0000000000000083.
PubMed 24691309Fraser JK, Wulur I, Alfonso Z, Hedrick MH. Fat tissue: an underappreciated source of stem cells for biotechnology. Trends Biotechnol. 2006 Apr;24(4):150-4. doi: 10.1016/j.tibtech.2006.01.010. Epub 2006 Feb 20.
PubMed 16488036An Y, Lin S, Tan X, Zhu S, Nie F, Zhen Y, Gu L, Zhang C, Wang B, Wei W, Li D, Wu J. Exosomes from adipose-derived stem cells and application to skin wound healing. Cell Prolif. 2021 Mar;54(3):e12993. doi: 10.1111/cpr.12993. Epub 2021 Jan 17.
PubMed 33458899Kim J, Kim B, Kim S, Lee YI, Kim J, Lee JH. The effect of human umbilical cord blood-derived mesenchymal stem cell media containing serum on recovery after laser treatment: A double-blinded, randomized, split-face controlled study. J Cosmet Dermatol. 2020 Mar;19(3):651-656. doi: 10.1111/jocd.13063. Epub 2019 Jul 22.
PubMed 31328871
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Exosomes in Patients After Q-switched Laser Surgery
- ClinicalTrials.gov ID
- NCT06279039
- Acronym / sponsor ID
- KY20230116-06
- Conditions
- Exosome, Skin Regeneration, Laser
- Keywords
- Exosome, Q-switched laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Feb 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.
the goal of this half-face controlled study is to evaluate the effect of exosome-containing liquid dressings on the recovery of patients after Nd:YAG laser 532 treatment.
Detailed description
The main objective was to collect patients with fleae or seborrheic keratosis after Q-switched laser treatment, and then to use exosomes or matrix on both sides of the face, and finally to evaluate the effect of exosomes on wound healing and prevention of post-inflammatory hyperpigmentation after Nd:YAG laser 532 treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| self half face control method | Experimental | Drug: Exosome liquid dressingOne side of the face was treated with exosome liquid dressing twice a day, and the other side was treated without exosome matrix for 2 weeks. The patients were followed up before treatment and 1, 3，7, 14, 28, and 56 days after treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- It meets the diagnostic criteria of seborrheic keratosis or freckle；
- pepole are able to follow the treatment rules of the study and were followed up for 8 weeks；
- informed consent
Key exclusion criteria (4 listed)
- History of keloids ;
- Pregnancy or lactation;
- Any cosmetics containing growth factor-related ingredients used within 6 months prior to treatment
- Patients with incomplete observation data and incomplete course of treatment were excluded
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 |
|---|---|---|
| Exosome liquid dressingAlso: followThis study mainly adopted a randomized double-blind self-half face control method. The double-blind method was that the subjects and researchers did not know the experimental group and the control group. 38 sets of matched use sets (left and right, only the manufacturer knew the specific ingredients) were respectively applied to both sides of the cheeks of patients after Q-switched laser. The blind was unblinded after the experiment. | Drug | self half face control method |
Primary outcome
Global Aesthetic Improvement Scale score
Time frame: 1, 3.5, 7, 14, 28, and 56 days
The treating physician evaluated the patient's improvement, which was divided into four levels: very improved corresponding, substantial improvement, improvement, no change; Corresponding to the best beauty results, significantly improved but not the best, significantly improved, no change
Dermatology Quality of life index
Time frame: 1, 3.5, 7, 14, 28, and 56 days
By answering multiple questions, patients self-rated the impact of their current illness on their lives within a week and scored. The answers were graded on four levels, very serious 3, very serious 2, a little 1, and no 0
1 secondary outcome
post-inflammatory hyperpigmentation
Time frame: 2.4,8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Results publication: PubMed 3624901Polla LL, Margolis RJ, Dover JS, Whitaker D, Murphy GF, Jacques SL, Anderson RR. Melanosomes are a primary target of Q-switched ruby laser irradiation in guinea pig skin. J Invest Dermatol. 1987 Sep;89(3):281-6. doi: 10.1111/1523-1747.ep12471397.
- Results publication: PubMed 30027914Aurangabadkar SJ. Optimizing Q-switched lasers for melasma and acquired dermal melanoses. Indian J Dermatol Venereol Leprol. 2019 Jan-Feb;85(1):10-17. doi: 10.4103/ijdvl.IJDVL_1086_16.
- Results publication: PubMed 7986124Kilmer SL, Wheeland RG, Goldberg DJ, Anderson RR. Treatment of epidermal pigmented lesions with the frequency-doubled Q-switched Nd:YAG laser. A controlled, single-impact, dose-response, multicenter trial. Arch Dermatol. 1994 Dec;130(12):1515-9.
- Results publication: PubMed 29601619Zoumalan CI. Topical Agents for Scar Management: Are They Effective? J Drugs Dermatol. 2018 Apr 1;17(4):421-425.
- Results publication: PubMed 9777970Stadelmann WK, Digenis AG, Tobin GR. Physiology and healing dynamics of chronic cutaneous wounds. Am J Surg. 1998 Aug;176(2A Suppl):26S-38S. doi: 10.1016/s0002-9610(98)00183-4.
- Results publication: PubMed 15094118Midwood KS, Williams LV, Schwarzbauer JE. Tissue repair and the dynamics of the extracellular matrix. Int J Biochem Cell Biol. 2004 Jun;36(6):1031-7. doi: 10.1016/j.biocel.2003.12.003.
- Results publication: PubMed 15691596Theoret CL. The pathophysiology of wound repair. Vet Clin North Am Equine Pract. 2005 Apr;21(1):1-13. doi: 10.1016/j.cveq.2004.11.001.
- Results publication: PubMed 24691309Toyserkani NM, Christensen ML, Sheikh SP, Sorensen JA. Adipose-Derived Stem Cells: New Treatment for Wound Healing? Ann Plast Surg. 2015 Jul;75(1):117-23. doi: 10.1097/SAP.0000000000000083.
- Results publication: PubMed 16488036Fraser JK, Wulur I, Alfonso Z, Hedrick MH. Fat tissue: an underappreciated source of stem cells for biotechnology. Trends Biotechnol. 2006 Apr;24(4):150-4. doi: 10.1016/j.tibtech.2006.01.010. Epub 2006 Feb 20.
- Results publication: PubMed 33458899An Y, Lin S, Tan X, Zhu S, Nie F, Zhen Y, Gu L, Zhang C, Wang B, Wei W, Li D, Wu J. Exosomes from adipose-derived stem cells and application to skin wound healing. Cell Prolif. 2021 Mar;54(3):e12993. doi: 10.1111/cpr.12993. Epub 2021 Jan 17.
- Results publication: PubMed 31328871Kim J, Kim B, Kim S, Lee YI, Kim J, Lee JH. The effect of human umbilical cord blood-derived mesenchymal stem cell media containing serum on recovery after laser treatment: A double-blinded, randomized, split-face controlled study. J Cosmet Dermatol. 2020 Mar;19(3):651-656. doi: 10.1111/jocd.13063. Epub 2019 Jul 22.
- Individual participant dataSharing planned: No
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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.
Jie Dai principal investigator
The First Affiliated Hospital with Nanjing 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 Exosome liquid dressing in people with Exosome and Skin Regeneration, run by Nanjing First Hospital, Nanjing Medical University 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jie Dai (02552271117, karry_dj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Aesthetic Improvement Scale score (time frame: 1, 3.5, 7, 14, 28, and 56 days). 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 NCT06279039, which also lists 11 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 26 Feb 2024.