Oral and Topical Tranexamic Acid for the Treatment of Mel... | NCT03585179

Studies
Oral and Topical Tranexamic Acid for the Treatment of Melasma

NCT03585179

Sponsor

Centro Dermatológico Dr. Ladislao de la Pascua

Status

Unknown status

Last Update Posted

Jul 16, 2018Actual

Enrollment

120Estimated

Phase

Phase 3

Conditions

Melasma
Chloasma
Melanosis

Interventions

Oral Tranexamic Acid
5% topical tranexamic acid
4% hydroquinone

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Estimated

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Jun 1, 2020Estimated

First Submitted Date

Jun 29, 2018

First Submission Date that Met QC Criteria

Jul 11, 2018

First Posted Date

Jul 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2018

Last Update Posted Date

Jul 16, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral tranexamic acid	Experimental	250 mg of tranexamic acid bid orally	Drug: Oral Tranexamic Acid
Topical tranexamic acid	Experimental	5% topical tranexamic acid bid	Drug: 5% topical tranexamic acid
Topical hydroquinone	Active Comparator	4% hydroquinone once daily at night	Drug: 4% hydroquinone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral Tranexamic Acid	Drug	Participants will take a pill of 250 mg bid for 12 weeks	Oral tranexamic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of mMASI (Modified Melasma Area and Severity Index)	The difference between mMASI (Modified Melasma Area and Severity Index) at week 0 and mMASI (Modified Melasma Area and Severity Index) at week 12	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Quality of life	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.	12 weeks
Melanin index

Other Outcomes

Not provided

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Martha A Morales-Sánchez, MD	Contact	55387033	312	mmoraless@sersalud.df.gob.mx

Overall Officials

Name	Affiliation	Role
Martha A Morales-Sánchez, MD	Centro Dermatológico Dr. Ladislao de la Pascua	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Dermatológico "Dr. Ladislao de la Pascua"		Mexico City		06780	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Description

Only if researchers ask for the complete data of the trial.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008548	Melanosis

Ancestor Terms

ID	Term
D017495	Hyperpigmentation
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014148	Tranexamic Acid
C031927	hydroquinone

Ancestor Terms

ID	Term
D003509	Cyclohexanecarboxylic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

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

ParticipantInvestigatorOutcomes Assessor