effect of Irsa(Iris Germanica L.) topical product on melasma

Phase 3

Recruiting

• Conditions: Melasma.; Chloasma; L81.1

• Registration Number: IRCT20230729058956N1
• Lead Sponsor: Shahed University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

Women aged 18-60 years
Having clear lesions of melasma with expert approval

Exclusion Criteria

Pregnancy or breastfeeding
Local or systemic treatment of melasma in the last 4 weeks
Use of hormonal drugs (OCP and corticosteroids).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Color index of melasma lesions. Timepoint: Measurement of the color index of melasma lesions at the beginning of the study (before the start of the intervention) and 4?8?12?16 weeks after the start of the use of Irsa topical product. Method of measurement: Comparing the amount of skin darkening compared to healthy skin (natural skin color 0, brief darkness 1, mild darkness 2, moderate darkness 3, severe darkness 4) by observation, photography and megometer device.

Secondary Outcome Measures

Name	Time	Method
The extent of melasma lesions. Timepoint: Measuring the extent of melasma lesions at the beginning of the study (before the start of theintervention) and 4?8?12?16 weaks after the start of using the Irsa topica lproduct. Method of measurement: Calculating the area of the lesion using MASI score and VISIOFACE.