Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

NCT03751163 | Completed Phase 3

• 1 other identifier: 008
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Melasma

Keywords

melasma; tranexamic acid; hydroquinone; mMASI; mexameter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Melanin index

  Baseline, week 2, 12, 24

Study Arms (2)

Study

ACTIVE COMPARATOR

Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks

Drug: Tranexamic Acid Oral Product; Drug: Hydroquinone 4% Cream; Other: Sunscreen

Control

PLACEBO COMPARATOR

Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks

Drug: Hydroquinone 4% Cream; Other: Sunscreen; Device: Placebo

Interventions

Tranexamic Acid Oral Product DRUG

Encapsulated tranexamic acid 250 mg

Also known as: TA

Study

Hydroquinone 4% Cream DRUG

Hydroquinone 4% Cream

Also known as: HQ

Control; Study

Sunscreen OTHER

Sunscreen SPF 30

Also known as: Sun Protection

Control; Study

Placebo DEVICE

Encapsulated placebo

Control

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

MeSH Terms

Conditions

Melanosis

Interventions

hydroquinone; Sunscreening Agents; Sun Protection Factor

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Radiometry

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 23, 2018
• Study Start: March 16, 2016
• Primary Completion: April 2, 2017
• Study Completion: April 2, 2017
• Last Updated: November 26, 2018

Record last verified: 2018-11