Assessment of the effect of exosomes in the treatment of melasma

Phase 1

Conditions: Melasma.
Other melanin hyperpigmentation
L81.4

Registration Number: IRCT20221130056672N6

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 30

Inclusion Criteria

Age between 18 and 50 years Full satisfaction of the participant in the plan Has melasma (with all three degrees of mild, moderate, severe)

Exclusion Criteria

Previous treatment of melasma
Pregnancy and Breastfeeding
Active skin infection
Use of drugs that can affect bleeding or clotting mechanism
Immunosuppression
Use of local and systemic steroids Disease systemic diseases (such as high blood pressure ,Diabetes ,heart, kidney and liver diseases)
The use of exfoliators 4 weeks before treatment In places where botulinum injection has been done, should not be done due to the possibility of microneedle toxin release.
Participation in other clinical trials

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The amount of melanin in the skin. Timepoint: Before starting the treatment and two months after the end of the treatment period (four months after the start of the treatment), biometric examination will be done. Method of measurement: Biometric device 9MPA-.;Examination of skin spots and skin color. Timepoint: Before starting the treatment and two months after the end of the treatment period (four months after the start of the treatment), biometric examination will be done. Method of measurement: Visoface biometric device.

Secondary Outcome Measures

Name	Time	Method
Recovery rate. Timepoint: before the start of treatment and two months after the end of the treatment period (four months after the start of treatment). Method of measurement: Photography with ImageJ software.;Judgment and satisfaction of patients. Timepoint: before the start of treatment and two months after the end of the treatment period (four months after the start of treatment). Method of measurement: Observation of photographs by two doctors and questionnaire.