## Protocol Section
### Identification Module
**NCT ID:** NCT03585179

**Acronym:** TRANEXAMICO

**Brief Title:** Oral and Topical Tranexamic Acid for the Treatment of Melasma

**Official Title:** Oral and 5% Topical Tranexamic Acid in Monotherapy Compared With 4% Topical Hydroquinone for the Treatment of Melasma: Three-arm Randomized, Double-blinded Clinical Trial

#### Organization Study ID Info
**ID:** 151/2018
#### Organization
**Class:** OTHER
**Full Name:** Centro Dermatológico Dr. Ladislao de la Pascua
### Status Module
#### Completion Date
**Date:** 2020-06-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2018-07-16

**Type:** ACTUAL

**Last Update Submit Date:** 2018-07-12

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-08-01

**Type:** ESTIMATED

**Status Verified Date:** 2018-07

#### Study First Post Date
**Date:** 2018-07-12
**Type:** ACTUAL
**Study First Submit Date:** 2018-06-29
**Study First Submit QC Date:** 2018-07-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centro Dermatológico Dr. Ladislao de la Pascua

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Tranexamic acid has been used for treating melasma due to its effect on decreasing the activity of tyrosinase and melanogenesis. This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks in adults with melasma. The primary outcome will be the percentage of reduction at 12-week period of mMASI and melanin index. The incidence of adverse effects will be reported at weeks 4, 8 and 12.

**Detailed Description:** Tranexamic acid has been used for treating melasma due to its effect on decreasing the activity of tyrosinase and melanogenesis. This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks in adults with melasma. One hundred and twenty patients will be recruited in 3 groups of intervention: group I with tranexamic acid at a dose of 250 mg bid orally, group II with 5% topical tranexamic acid bid, group III with 4% topical hydroquinone once daily. The primary outcome will be the percentage of reduction at 12-week period of mMASI and melanin index. The incidence of adverse effects will be reported at weeks 4, 8 and 12.

### Conditions Module

**Conditions:**

- Melasma

- Chloasma

- Melanosis

**Keywords:**

- Melasma

- Chloasma

- Melanosis

- Tranexamic acid

- Hydroquinone

- Therapeutics

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Three-arm clinical trial

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** Participants will receive both topical and oral interventions. Group 1: pills of tranexamic acid 250 mg bid plus placebo gel bid, Group 2: pills of placebo bid plus 5% tranexamic acid gel bid and Group 3: pills of placebo bid plus 4% hydroquinone cream at night and a placebo cream at morning. Containers will be of identical appearance.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 250 mg of tranexamic acid bid orally

**Intervention Names:**

- Drug: Oral Tranexamic Acid

**Label:** Oral tranexamic acid

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 5% topical tranexamic acid bid

**Intervention Names:**

- Drug: 5% topical tranexamic acid

**Label:** Topical tranexamic acid

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 4% hydroquinone once daily at night

**Intervention Names:**

- Drug: 4% hydroquinone

**Label:** Topical hydroquinone

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Oral tranexamic acid

**Description:** Participants will take a pill of 250 mg bid for 12 weeks

**Name:** Oral Tranexamic Acid

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Topical tranexamic acid

**Description:** Participants will apply a layer of gel on the affected skin bid for 12 weeks

**Name:** 5% topical tranexamic acid

**Other Names:**

- Topical tranexamic acid

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Topical hydroquinone

**Description:** Participants will apply a layer of cream on the affected skin once at night

**Name:** 4% hydroquinone

**Other Names:**

- Hydroquinone

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The difference between mMASI (Modified Melasma Area and Severity Index) at week 0 and mMASI (Modified Melasma Area and Severity Index) at week 12

**Measure:** Change of mMASI (Modified Melasma Area and Severity Index)

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Description:** The reported change of the score of DLQI (Dermatology Life Quality Index) at week 0 versus week 12. Total score ranges from 0 to 30 and the difference between the score at week 0 and week 12 will be calculated.

**Measure:** Change in Quality of life

**Time Frame:** 12 weeks

**Description:** The difference between melanin index at week 0 versus week 12. The melanin index will be measure with Mexameter® MX 18. Total index ranges from 0 to 999.

**Measure:** Melanin index

**Time Frame:** 12 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age older than 18 years
* Moderate to severe melasma
* History of multiple topical depigmenting treatments and use of photoprotection, with subjective improvement less than 50% or mMASI \<50% reported by the dermatologist after one year of treatment.

Exclusion Criteria:

* Pregnancy
* Hormonal contraception
* Lactation
* Treatment with hydroquinone or tranexamic acid at the time of the study or in the last 3 months
* Endocrinology diseases
* Hormone replacement therapy
* Family or personal history of one of the following: autoimmune disorders, coagulation disorders, chronic venous insufficiency, heart diseases, retinopathies, kidney disorders
* Mental disability

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mmoraless@sersalud.df.gob.mx

**Name:** Martha A Morales-Sánchez, MD

**Phone:** 55387033

**Phone Ext:** 312

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Mexico City

**Country:** Mexico

**Facility:** Centro Dermatológico "Dr. Ladislao de la Pascua"

**Zip:** 06780

#### Overall Officials

**Official 1:**

**Affiliation:** Centro Dermatológico Dr. Ladislao de la Pascua

**Name:** Martha A Morales-Sánchez, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** Only if researchers ask for the complete data of the trial.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017495

- Term: Hyperpigmentation

- ID: D000010859

- Term: Pigmentation Disorders

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M11531

- Name: Melanosis

- Relevance: HIGH

- As Found: Melasma

- ID: M19760

- Name: Hyperpigmentation

- Relevance: LOW

- As Found: Unknown

- ID: M13754

- Name: Pigmentation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008548

- Term: Melanosis

### Intervention Browse Module - Ancestors

- ID: D000000933

- Term: Antifibrinolytic Agents

- ID: D000050299

- Term: Fibrin Modulating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000006490

- Term: Hemostatics

- ID: D000003029

- Term: Coagulants

- ID: D000000975

- Term: Antioxidants

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000011837

- Term: Radiation-Protective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Coag

- Name: Coagulants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M16902

- Name: Tranexamic Acid

- Relevance: HIGH

- As Found: Needs

- ID: M6263

- Name: Coal Tar

- Relevance: LOW

- As Found: Unknown

- ID: M261781

- Name: Hydroquinone

- Relevance: HIGH

- As Found: Blood Lipid

- ID: M4252

- Name: Antifibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9576

- Name: Hemostatics

- Relevance: LOW

- As Found: Unknown

- ID: M6259

- Name: Coagulants

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14684

- Name: Radiation-Protective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000014148

- Term: Tranexamic Acid

- ID: C000031927

- Term: Hydroquinone

### Misc Info Module

- Version Holder: 2024-05-24
