MelasmaPhase 2/3NCT04599205
Evaluation of Laser and Tranexamic Acid in Treatment of Melasma
A Phase 2/3 study testing Tranexamic acid in people with Melasma, run by Assiut University.
Trial summary
Melasma Is an acquired, chronic, recurrent, symmetrical hypermelanosis, which is characterized by brown patches of variable darkness on sun exposed areas of the body. It is more common in women. It is common psychologically and emotionally distressing cosmetic problem in affected patients . Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Tranexamic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Dec 2022
- Phase
- Phase 2/3
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Gender: Only female patients.
- Age: 18-50 years old.
- Type of melasma: Bilateral symmetrical facial melasma of all types.
- Fitzpatrick skin phototypes: Types III, IV and V.
Who cannot join
- - Pregnancy and lactation.
- Patients taking oral contraceptive pills, hormonal replacement therapy or isotretinoin at the time of the study or during the past 6 months. Concomitant use of anticoagulants, bleeding disorders.
- Scarring and keloid tendency, active skin infections, active HSV, and those with facial cancer.
- History of photosensitivity or photosensitizing medications such as sulfonamides and tetracycline.
- Previous history of post inflammatory hyperpigmentation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Fractional CO2 Laser and Tranexamic Acid in Treatment of Melasma:Clinical,Histopathological and Immunohistochemical Study
Melasma Is an acquired, chronic, recurrent, symmetrical hypermelanosis, which is characterized by brown patches of variable darkness on sun exposed areas of the body. It is more common in women. It is common psychologically and emotionally distressing cosmetic problem in affected patients .
Read the detailed description
Many studies examined multiple treatment options for melasma , but none of them is completely satisfactory with recurrence in most cases.
Tranexamic acid is is a relatively new drug for melasma . It is currently used via a spectrum of delivery routes including oral, topical, intradermal, and microneedling .
Laser-assisted drug delivery (LADD) is a technique that facilitates the delivery of topical medications .
On reviewing the previous literatures, few studies have focused on therapeutic effects of combined laser and TXA (topical and intradermal) in melasma, with variations in parameters of laser, in dose, concentration, form and routes of TXA application; and in follow up duration. These studies revealed variable unproven results, and since melasma is a challenging disease, additional studies are needed to determine the optimal laser parameters and the best absorbable topical TXA formula, ensuring the best efficacy and less complications.
To the best of our knowledge, this is the first study that will use topical TXA gel as an additive effect between sessions, and to confirm the effect of laser and TXA by histopathology and immunohistochemistry.
- Conditions
- Melasma
- Being tested
- Tranexamic acid
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called laser, microneedling
fractional co2 laser, microneedling and topical tranexamic acid gel
| Study group | Role | What they receive |
|---|---|---|
| Microneedling group A | Experimental | Patients will be subjected to the following:
Combined laser (power=3.6 mJ) and topical tranexamic acid (TXA) (one finger unit) gel on the right half of the face.
Combined microneedling (by dermapen) and topical TXA gel only on the left half. Self application of topical TXA gel (2 finger units) on both sides on daily base. Receives: Drug: Tranexamic acid |
| Laser group B | Experimental | Patients will be subjected to the following:
Combined laser(power=3.6 mJ) and topical TXA gel (one finger unit) on the right half.
Laser (power=3.6 mJ) only on the left one. Receives: Drug: Tranexamic acid |
| Gel group C | Experimental | patients will be subjected to: Daily application of topical TXA gel (2 finger units) on both face sides. Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and effectiveness of fractional CO2 laser, microneedling and topical tranexamic acid gel
the therapeutic effect of combined fractional co2 laser and topical tranexamic acid versus either fractional co2 laser alone, topical TXA alone or combined microneedling and TXA in treatment of melasma.this will be assessed by melasma area and severity index (MASI).
Measured: 2 years
Secondary outcomes (1)
accurate outcome of each treatment modality
every modality's effect will be measured by the histopathological changes by use of fontana asson stain.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (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.
- More trials run by Assiut UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Hasan, Assiut University
- Investigators
- EMAN R MOHAMED, MD, Study director, assuit university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599205
- Sponsor's protocol ID
- EOFCLATAITOMCHAIS
- Status last verified
- Oct 2020
- First submitted
- 9 Sep 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fractional CO2 Laser and Tranexamic Acid in Treatment of Melasma:Clinical,Histopathological and Immunohistochemical Study
- ClinicalTrials.gov ID
- NCT04599205
- Acronym / sponsor ID
- EOFCLATAITOMCHAIS
- Conditions
- Melasma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Oct 2020 (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.
Melasma Is an acquired, chronic, recurrent, symmetrical hypermelanosis, which is characterized by brown patches of variable darkness on sun exposed areas of the body. It is more common in women. It is common psychologically and emotionally distressing cosmetic problem in affected patients .
Detailed description
Many studies examined multiple treatment options for melasma , but none of them is completely satisfactory with recurrence in most cases.
Tranexamic acid is is a relatively new drug for melasma . It is currently used via a spectrum of delivery routes including oral, topical, intradermal, and microneedling .
Laser-assisted drug delivery (LADD) is a technique that facilitates the delivery of topical medications .
On reviewing the previous literatures, few studies have focused on therapeutic effects of combined laser and TXA (topical and intradermal) in melasma, with variations in parameters of laser, in dose, concentration, form and routes of TXA application; and in follow up duration. These studies revealed variable unproven results, and since melasma is a challenging disease, additional studies are needed to determine the optimal laser parameters and the best absorbable topical TXA formula, ensuring the best efficacy and less complications.
To the best of our knowledge, this is the first study that will use topical TXA gel as an additive effect between sessions, and to confirm the effect of laser and TXA by histopathology and immunohistochemistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microneedling group A | Experimental | Drug: Tranexamic acidPatients will be subjected to the following: Combined laser (power=3.6 mJ) and topical tranexamic acid (TXA) (one finger unit) gel on the right half of the face. Combined microneedling (by dermapen) and topical TXA gel only on the left half. Self application of topical TXA gel (2 finger units) on both sides on daily base. |
| Laser group B | Experimental | Drug: Tranexamic acidPatients will be subjected to the following: Combined laser(power=3.6 mJ) and topical TXA gel (one finger unit) on the right half. Laser (power=3.6 mJ) only on the left one. |
| Gel group C | Experimental | Drug: Tranexamic acidpatients will be subjected to: Daily application of topical TXA gel (2 finger units) on both face sides. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- - Gender: Only female patients.
- Age: 18-50 years old.
- Type of melasma: Bilateral symmetrical facial melasma of all types.
- Fitzpatrick skin phototypes: Types III, IV and V.
Key exclusion criteria (5 listed)
- - Pregnancy and lactation.
- Patients taking oral contraceptive pills, hormonal replacement therapy or isotretinoin at the time of the study or during the past 6 months. Concomitant use of anticoagulants, bleeding disorders.
- Scarring and keloid tendency, active skin infections, active HSV, and those with facial cancer.
- History of photosensitivity or photosensitizing medications such as sulfonamides and tetracycline.
- Previous history of post inflammatory hyperpigmentation.
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 acidAlso: laser, microneedlingfractional co2 laser, microneedling and topical tranexamic acid gel | Drug | Gel group C, Laser group B, Microneedling group A |
Primary outcome
safety and effectiveness of fractional CO2 laser, microneedling and topical tranexamic acid gel
Time frame: 2 years
the therapeutic effect of combined fractional co2 laser and topical tranexamic acid versus either fractional co2 laser alone, topical TXA alone or combined microneedling and TXA in treatment of melasma.this will be assessed by melasma area and severity index (MASI).
1 secondary outcome
accurate outcome of each treatment modality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- 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.
EMAN R MOHAMED, MD study director
assuit university hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tranexamic acid in people with Melasma, run by Assiut University.
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 4 inclusion and 5 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 22 Oct 2020. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact aya H younis, MD (00201098898917, aya.h@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and effectiveness of fractional CO2 laser, microneedling and topical tranexamic acid gel (time frame: 2 years). 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 22 Oct 2020.