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

NCT06279039 | Recruiting DMC

• 1 other identifier: KY20230116-06
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exosome; Skin Regeneration; Laser

Keywords

Exosome; Q-switched laser

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• post-inflammatory hyperpigmentation

  2.4,8 weeks

Study Arms (1)

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

Drug: Exosome liquid dressing

Interventions

Exosome liquid dressing 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.

Also known as: follow

self half face control method

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Jie Dai

Nanjing, Jiangsu, 210006, China

RECRUITING

Related Publications (11)

• 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.

  PMID: 3624901 RESULT

• 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.

  PMID: 30027914 RESULT

• 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.

  PMID: 7986124 RESULT

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

  PMID: 29601619 RESULT

• 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.

  PMID: 9777970 RESULT

• 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.

  PMID: 15094118 RESULT

• 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.

  PMID: 15691596 RESULT

• 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.

  PMID: 24691309 RESULT

• 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.

  PMID: 16488036 RESULT

• 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.

  PMID: 33458899 RESULT

• 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.

  PMID: 31328871 RESULT

Study Officials

• Jie Dai

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jie Dai

CONTACT

02552271117; karry_dj@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nanjing First Hospital

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: February 26, 2024
• Study Start: September 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)