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

Not Applicable

Recruiting

• Conditions: Laser; Exosome; Skin Regeneration
• Interventions: Drug: Exosome liquid dressing

• Registration Number: NCT06279039
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

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 Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2023-04-06
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-20
• Last Update Submitted: 2024-02-20
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
self half face control method	Exosome liquid dressing	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

Primary Outcome Measures

Name	Time	Method
Global Aesthetic Improvement Scale score	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	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

Secondary Outcome Measures

Name	Time	Method
post-inflammatory hyperpigmentation	2.4,8 weeks	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.

Trial Locations

Locations (1)

Jie Dai; 🇨🇳 Nanjing, Jiangsu, China