MelasmaPhase 3NCT03751163
Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
A Phase 3 study testing Tranexamic Acid Oral Product, Hydroquinone 4% Cream and Sunscreen in people with Melasma, run by Fakultas Kedokteran Universitas Indonesia.
Trial summary
This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma. Read more about this study
- Who is it for?
- Ages 21 to 64 years, women only
- Conditions the study is for
- Melasma
- What is being tested?
- Tranexamic Acid Oral Product, Hydroquinone 4% Cream and Sunscreen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 16 Mar 2016to 2 Apr 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Randomized, Controlled, Double-blind Study of Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma.
Read the detailed 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.
- Conditions
- Melasma
- Being tested
- Tranexamic Acid Oral Product, Hydroquinone 4% Cream, Sunscreen, Placebo
- Keywords
- melasma, tranexamic acid, hydroquinone, mMASI, mexameter
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid Oral ProductDrug
Also called TA
Encapsulated tranexamic acid 250 mg
Hydroquinone 4% CreamDrug
Also called HQ
Hydroquinone 4% Cream
SunscreenOther
Also called Sun Protection
Sunscreen SPF 30
PlaceboDevice
Encapsulated placebo
| Study group | Role | What they receive |
|---|---|---|
| Study | Active comparator | Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks Receives: 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 Receives: Drug: Hydroquinone 4% Cream; Other: Sunscreen; Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, week 2, 12, 24
Secondary outcomes (1)
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.
Measured: Baseline, week 2, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start16 Mar 2016
- Primary completion2 Apr 2017
- Study completion2 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Shihab, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751163
- Sponsor's protocol ID
- 008
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Double-blind Study of Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT03751163
- Acronym / sponsor ID
- 008
- Conditions
- Melasma
- Keywords
- melasma, tranexamic acid, hydroquinone, mMASI, mexameter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 2 Apr 2017 (actual)
- Study completion
- 2 Apr 2017 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Active comparator | Drug: Tranexamic Acid Oral Product, Drug: Hydroquinone 4% Cream, Other: SunscreenTranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks |
| Control | Placebo comparator | Drug: Hydroquinone 4% Cream, Other: Sunscreen, Device: PlaceboPlacebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- pregnant women,
- nursing women,
- women on exogenous hormones
- current treatment with blood thinners,
- had a history of thrombosis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid Oral ProductAlso: TAEncapsulated tranexamic acid 250 mg | Drug | Study |
| Hydroquinone 4% CreamAlso: HQHydroquinone 4% Cream | Drug | Control, Study |
| SunscreenAlso: Sun ProtectionSunscreen SPF 30 | Other | Control, Study |
| PlaceboEncapsulated placebo | Device | Control |
Primary outcome
Change from Baseline mMASI Score at week 12
Time frame: Baseline, week 2, 12, 24
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)
1 secondary outcome
Melanin index
Time frame: Baseline, week 2, 12, 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
Related trials for Melasma
Enrolling by invitationPhase 4
Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma
Melasma (Facial Melasma)
Active, not recruitingPhase 4
Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
Melasma (Facial Melasma)
Not yet recruiting
COMPARISON OF TOPICAL VITAMIN C VS NIACINAMIDE IN TREATMENT OF MELASMA
Melasma
Not yet recruiting
New Treatment in Melasma
Female, With
Not yet recruitingPhase 4
Baseline Dermoscopic Vascular Score and Response to Oral Tranexamic Acid in Facial Melasma
Melasma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid Oral Product, Hydroquinone 4% Cream and Sunscreen in people with Melasma, run by Fakultas Kedokteran Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline mMASI Score at week 12 (time frame: Baseline, week 2, 12, 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.