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Effectiveness of subcutaneous Tranexamic acid injection and Hydroquinon cream in treatment of melasma

A comparative study of effectiveness and side effects between subcutaneous Tranexamic acid injection and Hydroquinon 4% cream in treatment of face melasma in patients referreing to Shohada-e-Tajrish and Loghman-e-Hakim hospitals

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015110324865N1
Enrollment
52
Registered
2016-09-17
Start date
2016-07-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Melasma. Chloasma

Interventions

Intervention 1: In the first group: After using of topical anesthesia at the injection site ( lidocaine cream 60 minutes before injection), Tranexamic acid ampoule intradermaly is injected into the m
Treatment - Drugs
In the first group: After using of topical anesthesia at the injection site ( lidocaine cream 60 minutes before injection), Tranexamic acid ampoule intradermaly is injected into the melasma lesions w
In the second group: About the amount of the usage of Hydroquinon 4% cream we use Finger Tip Unit indicator and the maximum dose in every usage is 1 gr. Treatment period is 12 weeks. Assessment of r

Sponsors

Vice-Chancellor in Research Affairs of Shahid Beheshti University of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Every patient between 20-50 years old that do not use any topical treatment for melasma at least 1 month before the trial and have epidermal melasma with wood 's lamp and do not have exclusion criteria. Exclusion criteria: Pregnancy and lactation; Dermal melasma; Using any treatment for melasma during 1 month ago; Using OCP or any hormonal or phototoxic drugs.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Hyperpigmentation homogeneity. Timepoint: Before intervention,4 weeks and 8 weeks after begining of the intervention and 4 weeks ater the end of the intervention. Method of measurement: MASI score.;Area involved. Timepoint: before intervention,4weeks and 8 weeks after begining of the intervention and 4 weeks ater the end of the intervention. Method of measurement: MASI score.;Darkness of pigment compared with normal skin. Timepoint: before intervention,4weeks and 8 weeks after begining of the intervention and 4 weeks ater the end of the intervention. Method of measurement: MASI score.

Secondary

MeasureTime frame
Erythema. Timepoint: 4 weeks and 8 weeks after beginning of the intervention and 4 weeks after the end of the intervention. Method of measurement: Asking the patient.;Irritation. Timepoint: 4 weeks and 8 weeks after beginning of the intervention and 4 weeks after the end of the intervention. Method of measurement: asking the patient.;Dryness. Timepoint: 4 weeks and 8 weeks after beginning of the intervention and 4 weeks after the end of the intervention. Method of measurement: Asking the patient.;Alergic reaction. Timepoint: 4 weeks and 8 weeks after beginning of the intervention and 4 weeks after the end of the intervention. Method of measurement: Asking the patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBita Saghi

Skin Research Center

dr.saghi2020@yahoo.com+98 21 2274 1507

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 23, 2026