evaluating effectiveness of combination therapy with niosomal kojic acid and arbutin in melasma

Comparision of niosomal kojic acid and arbutin with hydroquinone 4% in the treatment of melasma patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200623047891N1

Enrollment

Registered

2020-09-16

Start date

2020-07-21

Completion date

Unknown

Last updated

2023-10-16

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: Intervention group: niosomal combination of kojic acid and arbutin, route of administration: topical application, once daily

duration of treatment: 12 weeks

manufacturing factory: Shafa, Iran. Intervention 2: Control group: Hydroquinone 4% cream

route of administration: topical application, once daily

manufacturing factory: Shafa, Iran.

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: female patients with minimum age 18 years old patients with diagnosed melasma

Exclusion criteria

Exclusion criteria: pregnancy lactation OCP users history of allergy to the components of formulation

Design outcomes

Primary

Measure	Time frame
Physician satisfaction. Timepoint: 12 weeks after beginning of intervention. Method of measurement: Using Physician Global Assessment score.;Melasma severity. Timepoint: at the beginning of the study ( before intervention) and 12 weeks after intervention. Method of measurement: According to Melasma Area and Severity Index score.;Patient satisfaction. Timepoint: 12 weeks after beginning of the intervention and three months after end of the study. Method of measurement: Using Patient Global Assessment score.	—

Measure

Time frame

Physician satisfaction. Timepoint: 12 weeks after beginning of intervention. Method of measurement: Using Physician Global Assessment score.;Melasma severity. Timepoint: at the beginning of the study ( before intervention) and 12 weeks after intervention. Method of measurement: According to Melasma Area and Severity Index score.;Patient satisfaction. Timepoint: 12 weeks after beginning of the intervention and three months after end of the study. Method of measurement: Using Patient Global Assessment score.

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Secondary

Measure	Time frame
Erythema. Timepoint: At the begining of the study (before intervention) and 4, 8, 12 Weeks after begining of the intervention. Method of measurement: By question from patients and classification of the complications Severity into mild, moderate and severe.;Peeling. Timepoint: At the begining of the study (before intervention) and 4, 8, 12 Weeks after begining of the intervention. Method of measurement: By question from patients and classification of the complications Severity into mild, moderate and severe.	—

Measure

Time frame

Erythema. Timepoint: At the begining of the study (before intervention) and 4, 8, 12 Weeks after begining of the intervention. Method of measurement: By question from patients and classification of the complications Severity into mild, moderate and severe.;Peeling. Timepoint: At the begining of the study (before intervention) and 4, 8, 12 Weeks after begining of the intervention. Method of measurement: By question from patients and classification of the complications Severity into mild, moderate and severe.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRevan Amiri

Kerman University of Medical Sciences

rezvanamiri1358@yahoo.com+98 34 3132 8328

Outcome results

None listed

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