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

Laser Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279039
• Other study ID #: KY20230116-06
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: jie Dai
• Phone: 02552271117
• Email: karry_dj[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Laser

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Jie Dai	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1, 3.5, 7, 14, 28, and 56 days
Primary	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	1, 3.5, 7, 14, 28, and 56 days
Secondary	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.	2.4,8 weeks