MelasmaNCT05236569
Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V
A study testing Tranexamic acid injection and Injection Water in people with Melasma, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
A double-blind, randomized, split-face controlled trial of 34 female patients with melasma was conducted. All subject were randomized to receive either intradermal tranexamic acid or placebo injection on the right or the left side of their face. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Tranexamic acid injection and Injection Water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Feb 2021to 31 May 2021
- Phase
- Interventional
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18 to 60 years old
- Fitzpatrick skin type IV - V
- diagnosed with melasma
Who cannot join
- pregnancy and breastfeeding
- use of oral contraceptives within six months
- use of topical or systemic melasma therapy within two weeks
- history of superficial peeling within four weeks
- history of dermabrasion within six months
- use of photosensitizer drugs
Show all 9Show fewer
- history of thrombosis or currently using antithrombotic or anticoagulant drugs
- history of TA allergy
- experiencing any COVID-19 symptoms
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V: A Double-Blind Randomized Controlled Trial
A double-blind, randomized, split-face controlled trial of 34 female patients with melasma was conducted. All subject were randomized to receive either intradermal tranexamic acid or placebo injection on the right or the left side of their face.
Read the detailed description
All subject were randomized to receive either 10 mg of intradermal tranexamic acid or placebo injection on the right or the left side of their face.
The primary outcome was improvement of melasma lesions assessed by modified Melasma Area and Severity Index (mMASI) score and mexameter examination which includes Melanin Index (MI) and Erythema Index (EI).
Measurements were done at baseline and every two weeks for twelve weeks. Additionally, side effects of therapy and subjects' satisfactory assessment with patient global assessment (PtGA) were also documented.
- Conditions
- Melasma
- Being tested
- Tranexamic acid injection, Injection Water
- Keywords
- melasma, tranexamic acid, modified melasma area and severity index, melanin index, erythema index
- 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 injectionDrug
The tranexamic acid injection was given intradermally to the facial skin
Injection WaterDrug
The 0.9% normal saline injection was given intradermally to the facial skin
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | The intervention was 1 ml of 10 mg/ml of tranexamic acid solution which was given intradermally. Receives: Drug: Tranexamic acid injection |
| Placebo | Placebo comparator | The placebo was 1 ml of 0.9% normal saline which was given intradermally. Receives: Drug: Injection Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Melasma Area and Severity Index (mMASI) score
Reduction of mMASI score
Measured: 12 weeks
Erythema Index
Reduction of erythema index
Measured: 12 weeks
Melanin Index
Reduction of melanin index
Measured: 12 weeks
Secondary outcomes (2)
Side effects
Incidence of side effects
Measured: 12 weeks
Subject's satisfaction
Satisfaction towards the treatment's results measured by patient global assessment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Feb 2021
- Primary completion31 May 2021
- Study completion31 May 2021
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.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects were randomized to receive either 10 mg of intradermal tranexamic acid injection or placebo on one side of the face with 1:1 ratio. The allocation sequence was generated with a computer by an analyst.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vashty Amanda Hosfiar, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236569
- Sponsor's protocol ID
- 20-11-1376
- Status last verified
- Feb 2022
- First submitted
- 28 Jan 2022
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05236569
- Acronym / sponsor ID
- 20-11-1376
- Conditions
- Melasma
- Keywords
- melasma, tranexamic acid, modified melasma area and severity index, melanin index, erythema index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 11 Feb 2022 (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.
A double-blind, randomized, split-face controlled trial of 34 female patients with melasma was conducted. All subject were randomized to receive either intradermal tranexamic acid or placebo injection on the right or the left side of their face.
Detailed description
All subject were randomized to receive either 10 mg of intradermal tranexamic acid or placebo injection on the right or the left side of their face.
The primary outcome was improvement of melasma lesions assessed by modified Melasma Area and Severity Index (mMASI) score and mexameter examination which includes Melanin Index (MI) and Erythema Index (EI).
Measurements were done at baseline and every two weeks for twelve weeks. Additionally, side effects of therapy and subjects' satisfactory assessment with patient global assessment (PtGA) were also documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible subjects were randomized to receive either 10 mg of intradermal tranexamic acid injection or placebo on one side of the face with 1:1 ratio. The allocation sequence was generated with a computer by an analyst.
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic acid injectionThe intervention was 1 ml of 10 mg/ml of tranexamic acid solution which was given intradermally. |
| Placebo | Placebo comparator | Drug: Injection WaterThe placebo was 1 ml of 0.9% normal saline which was given intradermally. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 18 to 60 years old
- Fitzpatrick skin type IV - V
- diagnosed with melasma
Key exclusion criteria (9 listed)
- pregnancy and breastfeeding
- use of oral contraceptives within six months
- use of topical or systemic melasma therapy within two weeks
- history of superficial peeling within four weeks
- history of dermabrasion within six months
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 injectionThe tranexamic acid injection was given intradermally to the facial skin | Drug | Tranexamic acid |
| Injection WaterThe 0.9% normal saline injection was given intradermally to the facial skin | Drug | Placebo |
Primary outcome
Modified Melasma Area and Severity Index (mMASI) score
Time frame: 12 weeks
Reduction of mMASI score
Erythema Index
Time frame: 12 weeks
Reduction of erythema index
Melanin Index
Time frame: 12 weeks
Reduction of melanin index
2 secondary outcomes
Side effects
Time frame: 12 weeks
Subject's satisfaction
Time frame: 12 weeks
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 11 Feb 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid injection and Injection Water in people with Melasma, run by Universitas Indonesia at 1 site in 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 9 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 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Modified Melasma Area and Severity Index (mMASI) score (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 11 Feb 2022.