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Assessment of the effect of exosomes in the treatment of melasma

Assessment of Safety and Efficacy of Intradermal Injection of Wharton's jelly Mesenchymal Cells Derived Extracellular Vesicles With CO2 Laser in Treatment of Melasma(A randomized controlled intervention study)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221130056672N6
Enrollment
30
Registered
2024-02-04
Start date
2024-04-03
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma. Other melanin hyperpigmentation

Interventions

Intervention 1: Control group: CO2 laser is performed as a routine treatment for melasma disease, so group A patients are treated using CO2 laser with a wavelength of 30 j and for 5 minutes in the ski

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Taghiabadi

Tehran University of Medical Sciences

etaghiabadi@sina.tums.ac.ir+98 21 2665 7438

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026