Clinical Observation of Exosomes in Patients After Q-switched Laser Surgery

NCT ID: NCT06279039

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Exosome Skin Regeneration Laser

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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self half face control method

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

Group Type EXPERIMENTAL

Exosome liquid dressing

Intervention Type DRUG

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.

Interventions

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Exosome liquid dressing

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.

Intervention Type DRUG

Other Intervention Names

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follow

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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dai jie

Nanjing First Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jie Dai

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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Jie Dai

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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jie Dai

Role: CONTACT

02552271117

Facility Contacts

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jie dai

Role: primary

02552271117

References

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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.

Reference Type RESULT
PMID: 3624901 (View on PubMed)

Aurangabadkar 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.

Reference Type RESULT
PMID: 30027914 (View on PubMed)

Kilmer 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.

Reference Type RESULT
PMID: 7986124 (View on PubMed)

Zoumalan CI. Topical Agents for Scar Management: Are They Effective? J Drugs Dermatol. 2018 Apr 1;17(4):421-425.

Reference Type RESULT
PMID: 29601619 (View on PubMed)

Stadelmann 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.

Reference Type RESULT
PMID: 9777970 (View on PubMed)

Midwood 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.

Reference Type RESULT
PMID: 15094118 (View on PubMed)

Theoret 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.

Reference Type RESULT
PMID: 15691596 (View on PubMed)

Toyserkani 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.

Reference Type RESULT
PMID: 24691309 (View on PubMed)

Fraser 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.

Reference Type RESULT
PMID: 16488036 (View on PubMed)

An 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.

Reference Type RESULT
PMID: 33458899 (View on PubMed)

Kim 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.

Reference Type RESULT
PMID: 31328871 (View on PubMed)

Other Identifiers

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KY20230116-06

Identifier Type: -

Identifier Source: org_study_id

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