MelasmaPhase 2NCT05909072
Tranexamic Acid With Microneedling in Melasma
A Phase 2 study testing Hyaluronic acid combined with tranexamic acid microneedling and tranexamic acid microneedling in people with Melasma, run by Zagazig University.
Trial summary
Topical tranexamic, a hydrophilic molecule, can't pass the lipid barriers of the stratum corneum and it's also not retained in adequate amount in the epidermis to enter the melanocytes, so there's a difficulty in the effective delivery of tranexamic acid into the melanocytes . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melasma
- What is being tested?
- Hyaluronic acid combined with tranexamic acid microneedling and tranexamic acid microneedling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Dec 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged > 18 years.
- Both sexes.
- All types of melasma (epidermal, dermal and mixed).
- Nearly bilateral symmetrical melasma
Who cannot join
- Pregnancy and lactation
- Patients who are taking contraceptive pills at the time of the study or during the past 12 months.
- Patients with bleeding disorders with hypercoagulable state or the concomitant use of anticoagulants.
- Patient with history of thrombosis like DVT, coronary artery disease, stroke.
- Patient using any treatment for melasma during the past 1 month before the study.
- Active skin infection.
- Infection and immunosuppression
- Patient with keloidal tendency
About this study
Official title: The Boosting Effect of Hyaluronic Acid on Tranexamic Acid Microneedles in Melasma Patients: A Split- Face Study
Topical tranexamic, a hydrophilic molecule, can't pass the lipid barriers of the stratum corneum and it's also not retained in adequate amount in the epidermis to enter the melanocytes, so there's a difficulty in the effective delivery of tranexamic acid into the melanocytes .
Hyaluronic acid was proved to improve the effective delivery of tranexamic acid through loosening corneocyte packing and helping TXA entering the melanocytes and minimizing its epidermal diffusion .
Read the detailed description
Melasma is a common acquired pigmentary disorder characterized by irregular symmetric medium- to dark-brown macules and patches affecting the photoexposed areas of the face causing cosmetic disfigurement and low quality of life of the patient. Melsama affects mostly women of reproductive age with Fitzpatrick skin type IV-VI .
The exact pathogenesis of melasma isn't well-known, however the major etiological factors include genetic influences, chronic sun exposure, pregnancy, contraceptives, drugs and hormone therapy. Although the exact pathogenesis of melasma is not fully clarified, the pathophysiology of melasma is believed to involve excess production of melanin or an increase in the activity of melanocytes in the skin .
Melasma is often refractory to treatment with common relapses, so it needs a treatment modality that can be used for long time with minimal side effects. Topical depigmenting agents have good results but also may lead to many side effects.
Microneedling is a minimally invasive technique used for skin rejuvenation and treatment of many diseases, such as dyspigmentation. Gentle microneedling enhances upper dermal changes and increases the epidermal turnover that leads to decreasing melanin production and its deposition in melanocytes and also increasing the epidermal melanin cleareance which improve melasma.
Microneedling enhances transdermal drug delivery across the skin barrier through creating microchannels into the skin without causing actual epidermal damage. Microneedling with topical tranexamic acid (TXA) was proved to be safe, effective and comparatively painless without any detectable side effects.
Tranexamic acid, a hemostatic drug, is used to treat melasma by inhibiting the plasminogen activating system . The intracellular release of arachidonic acid, a precursor to prostaglandins E2, and the level of alpha-melanocyte-stimulating hormone increase as the result of plasmin activity. These two substances can activate melanogenesis. Therefore, the anti-plasmin activity of TA is thought as the main mechanism of hypopigmentory effect of this agent .
Tranexamic acid also inhibits angiogenesis of dermal blood vessels through suppression of vascular endothelial growth factor .
Topical tranexamic, a hydrophilic molecule, can't pass the lipid barriers of the stratum corneum and it's also not retained in adequate amount in the epidermis to enter the melanocytes, so there's a difficulty in the effective delivery of tranexamic acid into the melanocytes .
Hyaluronic acid (HA) was proved to improve the effective delivery of tranexamic acid through loosening corneocyte packing and helping TXA entering the melanocytes and minimizing its epidermal diffusion .
Hyaluronic acid also can actively adhere to melanocytes using cell suface HA receptors (such as cd44), so promotes the targeted delivery to melanocytes .
- Conditions
- Melasma
- Being tested
- Hyaluronic acid combined with tranexamic acid microneedling, tranexamic acid microneedling
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid combined with tranexamic acid microneedlingDrug
1 ml of TXA, available as a 500 mg/5 ml ampoule, will be applied on the right side of the face after microneedeling and left to dry
tranexamic acid microneedlingDrug
On the left side of face, 0.5 ml of HA 3.5% will be used 1st followed by microneedling then 1 ml of TXA will be applied
| Study group | Role | What they receive |
|---|---|---|
| right side of the face | Active comparator | microneedling with tranexamic acid alone on the right side of the face Receives: Drug: tranexamic acid microneedling |
| Left side of the face | Active comparator | microneedling with tranexamic acid combined with hyaluronic acid on the left side Receives: Drug: Hyaluronic acid combined with tranexamic acid microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Melasma Area Severity Index (mMASI) score
Hemi-mMASI for each half of the face is calculated according to the following formula:
Hemi-mMASI = 0.15 (A) (D) F + 0.3 (A) (D) M + 0.05 (A) (D) C
Measured: through study completion, an average of 9 months
Physician global evaluation
The improvement of patients is evaluated regarding the improvement in mMASI ( ) and graded as follow:
Poor (improvement < 25%) Fair (improvement 26%-50%) Good (improvement 51%-75%) Excellent (improvement >75%)
Measured: through study completion, an average of 9 months
A five-point Likert scale for patient's satisfaction
Level of patient satisfaction is scored on five points:
- Not at all satisfied
- Not really satisfied
- Undecided
- Somewhat satisfied
- Very much satisfied
Measured: through study completion, an average of 9 months
Pain assessment
Pain during the session will be assessed and graded as mild, moderate and severe
Measured: through study completion, an average of 9 months
Dermoscopic evaluation
Dermoscopy will be performed for each patient at baseline, during and after each follow-up visit to evaluate the improvement of:
- Color (light brown, brown, dark brown)
- Pigmentation (pseudo network and arcuate lesions)
- Vascularity (present or absent telangiectasia)
Measured: through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Norhan Anees, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909072
- Sponsor's protocol ID
- melasma
- Status last verified
- Jun 2023
- First submitted
- 17 Feb 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Boosting Effect of Hyaluronic Acid on Tranexamic Acid Microneedles in Melasma Patients: A Split- Face Study
- ClinicalTrials.gov ID
- NCT05909072
- Acronym / sponsor ID
- melasma
- Conditions
- Melasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Jun 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Jun 2023 (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.
Topical tranexamic, a hydrophilic molecule, can't pass the lipid barriers of the stratum corneum and it's also not retained in adequate amount in the epidermis to enter the melanocytes, so there's a difficulty in the effective delivery of tranexamic acid into the melanocytes .
Hyaluronic acid was proved to improve the effective delivery of tranexamic acid through loosening corneocyte packing and helping TXA entering the melanocytes and minimizing its epidermal diffusion .
Detailed description
Melasma is a common acquired pigmentary disorder characterized by irregular symmetric medium- to dark-brown macules and patches affecting the photoexposed areas of the face causing cosmetic disfigurement and low quality of life of the patient. Melsama affects mostly women of reproductive age with Fitzpatrick skin type IV-VI .
The exact pathogenesis of melasma isn't well-known, however the major etiological factors include genetic influences, chronic sun exposure, pregnancy, contraceptives, drugs and hormone therapy. Although the exact pathogenesis of melasma is not fully clarified, the pathophysiology of melasma is believed to involve excess production of melanin or an increase in the activity of melanocytes in the skin .
Melasma is often refractory to treatment with common relapses, so it needs a treatment modality that can be used for long time with minimal side effects. Topical depigmenting agents have good results but also may lead to many side effects.
Microneedling is a minimally invasive technique used for skin rejuvenation and treatment of many diseases, such as dyspigmentation. Gentle microneedling enhances upper dermal changes and increases the epidermal turnover that leads to decreasing melanin production and its deposition in melanocytes and also increasing the epidermal melanin cleareance which improve melasma.
Microneedling enhances transdermal drug delivery across the skin barrier through creating microchannels into the skin without causing actual epidermal damage. Microneedling with topical tranexamic acid (TXA) was proved to be safe, effective and comparatively painless without any detectable side effects.
Tranexamic acid, a hemostatic drug, is used to treat melasma by inhibiting the plasminogen activating system . The intracellular release of arachidonic acid, a precursor to prostaglandins E2, and the level of alpha-melanocyte-stimulating hormone increase as the result of plasmin activity. These two substances can activate melanogenesis. Therefore, the anti-plasmin activity of TA is thought as the main mechanism of hypopigmentory effect of this agent .
Tranexamic acid also inhibits angiogenesis of dermal blood vessels through suppression of vascular endothelial growth factor .
Topical tranexamic, a hydrophilic molecule, can't pass the lipid barriers of the stratum corneum and it's also not retained in adequate amount in the epidermis to enter the melanocytes, so there's a difficulty in the effective delivery of tranexamic acid into the melanocytes .
Hyaluronic acid (HA) was proved to improve the effective delivery of tranexamic acid through loosening corneocyte packing and helping TXA entering the melanocytes and minimizing its epidermal diffusion .
Hyaluronic acid also can actively adhere to melanocytes using cell suface HA receptors (such as cd44), so promotes the targeted delivery to melanocytes .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| right side of the face | Active comparator | Drug: tranexamic acid microneedlingmicroneedling with tranexamic acid alone on the right side of the face |
| Left side of the face | Active comparator | Drug: Hyaluronic acid combined with tranexamic acid microneedlingmicroneedling with tranexamic acid combined with hyaluronic acid on the left side |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged > 18 years.
- Both sexes.
- All types of melasma (epidermal, dermal and mixed).
- Nearly bilateral symmetrical melasma
Key exclusion criteria (8 listed)
- Pregnancy and lactation
- Patients who are taking contraceptive pills at the time of the study or during the past 12 months.
- Patients with bleeding disorders with hypercoagulable state or the concomitant use of anticoagulants.
- Patient with history of thrombosis like DVT, coronary artery disease, stroke.
- Patient using any treatment for melasma during the past 1 month before the study.
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 |
|---|---|---|
| Hyaluronic acid combined with tranexamic acid microneedling1 ml of TXA, available as a 500 mg/5 ml ampoule, will be applied on the right side of the face after microneedeling and left to dry | Drug | Left side of the face |
| tranexamic acid microneedlingOn the left side of face, 0.5 ml of HA 3.5% will be used 1st followed by microneedling then 1 ml of TXA will be applied | Drug | right side of the face |
Primary outcome
Modified Melasma Area Severity Index (mMASI) score
Time frame: through study completion, an average of 9 months
Hemi-mMASI for each half of the face is calculated according to the following formula: Hemi-mMASI = 0.15 (A) (D) F + 0.3 (A) (D) M + 0.05 (A) (D) C
Physician global evaluation
Time frame: through study completion, an average of 9 months
The improvement of patients is evaluated regarding the improvement in mMASI ( ) and graded as follow: Poor (improvement < 25%) Fair (improvement 26%-50%) Good (improvement 51%-75%) Excellent (improvement >75%)
A five-point Likert scale for patient's satisfaction
Time frame: through study completion, an average of 9 months
Level of patient satisfaction is scored on five points: 1. Not at all satisfied 2. Not really satisfied 3. Undecided 4. Somewhat satisfied 5. Very much satisfied
Pain assessment
Time frame: through study completion, an average of 9 months
Pain during the session will be assessed and graded as mild, moderate and severe
Dermoscopic evaluation
Time frame: through study completion, an average of 9 months
Dermoscopy will be performed for each patient at baseline, during and after each follow-up visit to evaluate the improvement of: * Color (light brown, brown, dark brown) * Pigmentation (pseudo network and arcuate lesions) * Vascularity (present or absent telangiectasia)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyaluronic acid combined with tranexamic acid microneedling and tranexamic acid microneedling in people with Melasma, run by Zagazig 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 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. 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 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.
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?
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 Severity Index (mMASI) score (time frame: through study completion, an average of 9 months). The study lists 5 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 18 Jun 2023; AzTrials last refreshed its copy on 30 Oct 2026.