Evaluating effectiveness of therapy with topical isoniazid in melasma

Comparison of the Efficacy of topical isoniazid versus placebo in the treatment of patients with melasma in a randomized double-blind clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211125053175N1

Enrollment

Registered

2022-01-29

Start date

2022-02-20

Completion date

Unknown

Last updated

2022-02-07

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:Isonicotinic acid hydrazide cream 10%. How to use: Topical use, once daily. Duration of treatment: 12 weeks. Manufacturing factory: Exir, Iran. Intervention 2: Contr

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients with minimum age 20 years old to maximum 60 years old Patients with diagnosed melasma

Exclusion criteria

Exclusion criteria: Other topical medication users for melasma in the last four weeks Kubner-positive diseases such as vitiligo Lactation and pregnancy Not consent to medical photography

Design outcomes

Primary

Measure	Time frame
Melanin content. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: According to Quantitative measurement of erythema and pigmentation of the patient's skin by Swiss made Dermocatch device.;Efficacy. Timepoint: Percentage change in melanin content before intervention and ?12 weeks after intervention. Method of measurement: Quantitative measurement of pigmentation of the patient's skin by Swiss made Dermocatch device.;Erythema content. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: Using Quantitative measurement of erythema and pigmentation of the patient's skin by Swiss made Dermocatch device.	—

Measure

Time frame

Melanin content. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: According to Quantitative measurement of erythema and pigmentation of the patient's skin by Swiss made Dermocatch device.;Efficacy. Timepoint: Percentage change in melanin content before intervention and ?12 weeks after intervention. Method of measurement: Quantitative measurement of pigmentation of the patient's skin by Swiss made Dermocatch device.;Erythema content. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: Using Quantitative measurement of erythema and pigmentation of the patient's skin by Swiss made Dermocatch device.

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Secondary

Measure	Time frame
Erythema. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: By physical examination and classification of the complications severity into mild, moderate and severe.;Scaling. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: By physical examination and classification of the complications severity into mild, moderate and severe.;Burning sensation. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: By physical examination and classification of the complications severity into mild, moderate and severe.;Increased liver enzymes. Timepoint: At the begining of the study (before intervention) and 12 weeks after intervention. Method of measurement: Based on blood test findings.	—

Measure

Time frame

Erythema. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: By physical examination and classification of the complications severity into mild, moderate and severe.;Scaling. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: By physical examination and classification of the complications severity into mild, moderate and severe.;Burning sensation. Timepoint: At the begining of the study (before intervention) and 4, 8 and12 weeks after intervention. Method of measurement: By physical examination and classification of the complications severity into mild, moderate and severe.;Increased liver enzymes. Timepoint: At the begining of the study (before intervention) and 12 weeks after intervention. Method of measurement: Based on blood test findings.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactRezvan 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