Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

Melasma Clinical Trial

Official title:

Randomized, Controlled, Double-blind Study of Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03751163
• Other study ID #: 008
• Status: Completed
• Phase: Phase 3
• Start date: March 16, 2016
• Est. completion date: April 2, 2017

Study information

• Verified date: November 2018
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma.

Description:

Hydroquinone (HQ) is considered the gold standard depigmenting agent for melasma, nevertheless, many patients are recalcitrant to this treatment.

Recent studies have shown that tranexamic acid, a plasmin inhibitor, can prevent UV-induced pigmentation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2, 2017
• Est. primary completion date: April 2, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 64 Years

Eligibility

Inclusion Criteria:

• moderate melasma (subject with mMASI score of 5 to 7.9),

• severe melasma (subject with mMASI score = 8),

• willing to follow up for 6 months.

Exclusion Criteria:

• pregnant women,

• nursing women,

• women on exogenous hormones

• current treatment with blood thinners,

• had a history of thrombosis,

• had an abnormal kidney function,

• use of topical hydroquinone within 3 months of study enrollment,

• use of topical steroids, vitamin A analogs, chemical peels within 1 month of study

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• Tranexamic Acid Oral Product
Encapsulated tranexamic acid 250 mg
• Hydroquinone 4% Cream
Hydroquinone 4% Cream

Other:
• Sunscreen
Sunscreen SPF 30

Device:
• Placebo
Encapsulated placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline mMASI Score at week 12	modified Melasma Area and Severity Index (mMASI) score was performed by rating darkness and area of involvement of 4 areas of the face (forehead, right malar, left malar, chin); Scoring system: A, Area of involvement rated 0 to 6: 0 indicates absent; 1, <10%; 2, 10% to 29%; 3, 30% to 49%; 4, 50% to 69%; 5, 70% to 89%; 6, 90% to 100%. D, Darkness rated 0 to 4: 0 indicates absent; 1, slight; 2, mild; 3, marked; 4, severe. b Total mMASI score range is 0 to 24 and calculated by adding scores for 4 areas of the face.; Forehead (0.3xAxD) + Right Malar (0.3xAxD) + Left Malar (0.3xAxD) + Chin (0.1xAxD)	Baseline, week 2, 12, 24
Secondary	Melanin index	difference in pigmentation readings between involved and adjacent uninvolved skin, was measured using a mexameter.; Mexameter is a simple, rapid, and completely non-invasive instrument which measures skin pigmentation. The device has a probe which is gently pressed on the skin and painlessly records the level of pigmentation using a range of 1-1000, with 1 corresponding to white and 1000 to black.	Baseline, week 2, 12, 24