MelasmaNCT03008655
1064-nm Q-switched Nd:YAG Laser and Intradermal Tranexamic Acid for Melasma
A study testing intradermal tranexamic acid and Nd-YAG in people with Melasma, run by Taipei Medical University WanFang Hospital.
Trial summary
BACKGROUND: Melasma is a chronic, often relapsing skin disorder, with poor long-term results from all current therapies.Q switched 1064nm Nd:YAG laser and intradermal tranexamic acid both showed efficacy on the treatment of melasma. However, no combination therapy of both be reported. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Melasma
- What is being tested?
- intradermal tranexamic acid and Nd-YAG
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2017
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients > 20 years old with refractory melasma to topical treatment
Who cannot join
- History of keloid, active eczema, active acne in the face, history of facial eczema, photosensitivity, use of isotretinoin in the past 6 months, pregnancy, and high exposure to sunlight or UV light (UVA or UVB)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Split-face Comparison of Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Vitamin C vs Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Intradermal Tranexamic Acid Injection for Melasma:a Single Blinded, Randomised Study
BACKGROUND: Melasma is a chronic, often relapsing skin disorder, with poor long-term results from all current therapies.Q switched 1064nm Nd:YAG laser and intradermal tranexamic acid both showed efficacy on the treatment of melasma. However, no combination therapy of both be reported.
OBJECTIVES: To compare the efficacy of low influence Q switched 1064nm Nd:YAG laser and low influence Q switched 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection for melasma.
Read the detailed description
METHODS: Twenty patients with melasma were included in a randomized controlled observer-blinded study with split-face design. Each side of the face was randomly allocated to either six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz) or low influence 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection.Complication Improvement of melasma was assessed by Melasma area severity index (MASI),physician's global assessment (PhGA), MELASQOL scale, patient's global assessment (PGA), and patient's satisfaction at baseline,6th week,10th week after first treatment and 3 months, and 6 months after last treatment.
- Conditions
- Melasma
- Being tested
- intradermal tranexamic acid, Nd-YAG
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradermal tranexamic acidProcedure or surgery
intradermal tranexamic acid injection
Nd-YAGDevice
six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz)
| Study group | Role | What they receive |
|---|---|---|
| Nd-YAG | Active comparator | ND-YAG only Receives: Device: Nd-YAG |
| Nd-YAG and intradermal tranexamic acid | Experimental | Nd-YAG combine with intradermal tranexamic acid Receives: Procedure: intradermal tranexamic acid; Device: Nd-YAG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melasma area severity index (MASI)
Measured: 6 months after last treatment
Secondary outcomes (4)
Quality of life by MELASQOL scale
Measured: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Improvement by patient's global assessment (PGA),
Measured: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Patient's satisfaction (VAS)
Measured: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Improvement by physician's global assessment (PhGA)
Measured: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Yu Chen, Taipei Medical University WanFang Hospital
- Investigators
- Yu Chen Huang, MD, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008655
- Sponsor's protocol ID
- N201610008
- Status last verified
- Dec 2016
- First submitted
- 22 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Split-face Comparison of Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Vitamin C vs Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Intradermal Tranexamic Acid Injection for Melasma:a Single Blinded, Randomised Study
- ClinicalTrials.gov ID
- NCT03008655
- Acronym / sponsor ID
- N201610008
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Jan 2017 (estimated)
- 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.
BACKGROUND: Melasma is a chronic, often relapsing skin disorder, with poor long-term results from all current therapies.Q switched 1064nm Nd:YAG laser and intradermal tranexamic acid both showed efficacy on the treatment of melasma. However, no combination therapy of both be reported.
OBJECTIVES: To compare the efficacy of low influence Q switched 1064nm Nd:YAG laser and low influence Q switched 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection for melasma.
Detailed description
METHODS: Twenty patients with melasma were included in a randomized controlled observer-blinded study with split-face design. Each side of the face was randomly allocated to either six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz) or low influence 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection.Complication Improvement of melasma was assessed by Melasma area severity index (MASI),physician's global assessment (PhGA), MELASQOL scale, patient's global assessment (PGA), and patient's satisfaction at baseline,6th week,10th week after first treatment and 3 months, and 6 months after last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nd-YAG | Active comparator | Device: Nd-YAGND-YAG only |
| Nd-YAG and intradermal tranexamic acid | Experimental | Procedure: intradermal tranexamic acid, Device: Nd-YAGNd-YAG combine with intradermal tranexamic acid |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients > 20 years old with refractory melasma to topical treatment
Key exclusion criteria (1 listed)
- History of keloid, active eczema, active acne in the face, history of facial eczema, photosensitivity, use of isotretinoin in the past 6 months, pregnancy, and high exposure to sunlight or UV light (UVA or UVB)
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 |
|---|---|---|
| intradermal tranexamic acidintradermal tranexamic acid injection | Procedure or surgery | Nd-YAG and intradermal tranexamic acid |
| Nd-YAGsix session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz) | Device | Nd-YAG, Nd-YAG and intradermal tranexamic acid |
Primary outcome
Melasma area severity index (MASI)
Time frame: 6 months after last treatment
4 secondary outcomes
Quality of life by MELASQOL scale
Time frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Improvement by patient's global assessment (PGA),
Time frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Patient's satisfaction (VAS)
Time frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Improvement by physician's global assessment (PhGA)
Time frame: 6th week,10th week after first treatment and 3 months, and 6 months after last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- 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.
Yu Chen Huang, MD principal investigator
Taipei Medical University WanFang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing intradermal tranexamic acid and Nd-YAG in people with Melasma, run by Taipei Medical University WanFang Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Jan 2017. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Chen Huang, MD (886970746772, dhist2002@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melasma area severity index (MASI) (time frame: 6 months after last treatment). 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 2 Jan 2017.