MelasmaNCT07540702
Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid for Melasma
A study testing Injectable Platelet-Rich Fibrin and Tranexamic acid 100 mg/mL (Kapron) in people with Melasma and Facial Melasma, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Melasma is a chronic acquired hyperpigmentation disorder that commonly affects the face and has a significant impact on quality of life. Available treatments may improve pigmentation, but relapse is common and response can be variable. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Melasma, Facial Melasma
- What is being tested?
- Injectable Platelet-Rich Fibrin and Tranexamic acid 100 mg/mL (Kapron)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of bilateral symmetrical facial melasma (epidermal or mixed type)
- Female participants aged 18 to 50 years
- Fitzpatrick skin types III to IV
- Mild to moderate facial melasma
- No melasma-specific treatment within the previous 4 weeks
- No facial procedures, including peeling, laser resurfacing, or microneedling, within the previous 3 months
- Willing and able to provide written informed consent and comply with study procedures
Who cannot join
- Pregnancy or lactation
- Bleeding or coagulation disorders
- Use of anticoagulants, nonsteroidal anti-inflammatory drugs (NSAIDs), or hormonal contraception
- Active skin infection or facial inflammation
- History of keloids or Koebner-prone conditions, such as psoriasis or vitiligo
- Uncontrolled systemic disease, such as diabetes mellitus or autoimmune disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kasr El Aini Hospital
Cairo, Cairo Governorate, 11555
Heba Ahmed, Lecturer of Dermatology, +201016532351, drhebaahmedyt@gmail.com
About this study
Official title: Assessment of Efficacy and Safety of Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid in the Treatment of Melasma: A Randomized Split-Face Study
Melasma is a chronic acquired hyperpigmentation disorder that commonly affects the face and has a significant impact on quality of life. Available treatments may improve pigmentation, but relapse is common and response can be variable.
This randomized split-face interventional study aims to compare the efficacy and safety of injectable platelet-rich fibrin (i-PRF) versus intradermal tranexamic acid (TA) in the treatment of facial melasma. Adult female patients with bilateral symmetrical facial melasma will be enrolled. In each participant, one side of the face will be randomly assigned to receive i-PRF and the contralateral side will receive intradermal TA.
Read more
Patients will undergo five treatment sessions at 2-week intervals. Clinical response will be assessed using the modified Melasma Area and Severity Index (mMASI), Antera 3D camera measurements, Physician Global Assessment, patient satisfaction, and Melasma Quality of Life (MelasQoL) questionnaire. Safety will be evaluated by recording adverse events such as pain, tenderness, erythema, swelling, infection, ecchymosis, and hematoma.
The study is designed to determine whether i-PRF is an effective and safe treatment option for melasma compared with intradermal tranexamic acid.
Read the detailed description
Melasma is a common chronic hyperpigmentation disorder characterized by symmetric brown to gray-brown patches, most commonly affecting the face. It is more frequent in women and in individuals with darker skin phototypes, and it may significantly impair psychosocial well-being and quality of life. Multiple pathogenic mechanisms have been implicated, including ultraviolet exposure, hormonal influences, genetic predisposition, melanocyte hyperactivity, and dermal vascular and inflammatory changes.
Current melasma therapies include topical depigmenting agents, chemical peels, laser and light-based procedures, and oral or local tranexamic acid. However, treatment response is often incomplete and recurrence is common. Intradermal tranexamic acid has shown promising results in reducing pigmentation through inhibition of plasmin activity and downstream melanocyte stimulation.
Injectable platelet-rich fibrin (i-PRF) is a second-generation autologous platelet concentrate prepared without anticoagulants. It provides a fibrin scaffold and gradual release of growth factors. Based on its biologic activity, i-PRF may have a therapeutic role in melasma by modulating melanogenesis, oxidative stress, and tissue repair. Despite this rationale, clinical evidence for i-PRF in melasma remains limited.
This study is a randomized split-face clinical trial designed to compare the efficacy and safety of i-PRF versus intradermal tranexamic acid in the treatment of facial melasma. Twenty-one adult female patients with mild to moderate bilateral symmetrical facial melasma, aged 18 to 50 years and with Fitzpatrick skin types III to IV, will be recruited from the outpatient dermatology clinic and cosmetology unit of Kasr El Ainy Hospital, Cairo University, Cairo, Egypt.
For each participant, one side of the face will be randomly assigned to receive i-PRF, while the contralateral side will receive intradermal tranexamic acid. Injectable platelet-rich fibrin (i-PRF) will be prepared from 10 mL of venous blood collected under aseptic conditions in a plain plastic tube and centrifuged at 60 g (700 rpm) for 3 minutes. The resulting i-PRF will be injected intradermally on the randomized side after topical anesthetic application. The opposite side will receive intradermal tranexamic acid prepared under aseptic conditions and injected at 1 cm intervals into melasma lesions. Participants will receive five treatment sessions at 2-week intervals. They will also be instructed to use broad-spectrum sunscreen and to avoid other topical facial treatments during the study period.
Both participants and outcome assessors will be blinded to the treatment allocation. Assessment will be performed at baseline and at the end of the study (Day 90). The primary outcome is the percent change in modified Melasma Area and Severity Index (mMASI) score from baseline to Day 90 between the i-PRF-treated side and the tranexamic-acid-treated side. Secondary outcomes include change in melanin level and vascular features measured by Antera 3D camera, Physician Global Assessment, patient satisfaction, global improvement scale, Melasma Quality of Life (MelasQoL) score, and adverse events.
Potential adverse effects include pain, tenderness, erythema, swelling, infection, ecchymosis, hematoma, and pigmentation changes. The study aims to determine whether i-PRF is an effective and safe therapeutic option for melasma compared with intradermal tranexamic acid.
- Conditions
- Melasma, Facial Melasma
- Being tested
- Injectable Platelet-Rich Fibrin, Tranexamic acid 100 mg/mL (Kapron)
- Keywords
- Injectable platelet-rich fibrin, i-PRF, Tranexamic acid, Melasma, Split-face study
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable Platelet-Rich FibrinBiological
Injectable platelet-rich fibrin (i-PRF) is prepared from 10 mL of autologous venous blood collected in a plain plastic tube without additives and centrifuged at 60 g (700 rpm) for 3 minutes. The resulting fluid is aspirated immediately and injected intradermally on the randomized side of the face at a dose of 0.1 mL/cm² at 1-cm intervals using a 30-gauge insulin syringe. Five treatment sessions are administered at 2-week intervals.
Tranexamic acid 100 mg/mL (Kapron)Drug
Tranexamic acid (Kapron ampoules, 100 mg/mL) is diluted under aseptic conditions to a final concentration of 10 mg/mL by adding 0.1 mL of tranexamic acid to normal saline to a total volume of 1 mL. After topical anesthetic application, approximately 1 mL of the prepared 10 mg/mL solution is injected intradermally into melasma lesions on the contralateral side of the face at 1-cm intervals using a 30-gauge insulin syringe. Five treatment sessions are administered at 2-week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Injectable Platelet-Rich Fibrin Side | Experimental | In this randomized split-face study, one side of each participant's face is randomly assigned to receive injectable platelet-rich fibrin (i-PRF). i-PRF is prepared from autologous venous blood and injected intradermally on the assigned side after topical anesthetic. Participants receive 5 treatment sessions at 2-week intervals. Receives: Biological: Injectable Platelet-Rich Fibrin |
| Intradermal Tranexamic Acid Side | Active comparator | In this randomized split-face study, the contralateral side of each participant's face receives intradermal tranexamic acid after topical anesthetic. Tranexamic acid is prepared under aseptic conditions and injected intradermally into melasma lesions. Participants receive 5 treatment sessions at 2-week intervals. Receives: Drug: Tranexamic acid 100 mg/mL (Kapron) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Modified Melasma Area and Severity Index (mMASI) Score
The percent change in modified Melasma Area and Severity Index (mMASI) score from baseline to Day 90 will be assessed and compared between the facial side treated with injectable platelet-rich fibrin (i-PRF) and the contralateral facial side treated with intradermal tranexamic acid.
Measured: Baseline and Day 90
Secondary outcomes (6)
Change in Melanin Level Measured by Antera 3D Camera
Change in average melanin level from baseline to Day 90, as measured by Antera 3D camera, will be assessed and compared between the facial side treated with injectable platelet-rich fibrin (i-PRF) and the contralateral facial side treated with intradermal tranexamic acid.
Measured: Baseline and Day 90
Change in Vascular Features Measured by Antera 3D Camera
Change in vascular features, including hemoglobin/erythema index, from baseline to Day 90, as measured by Antera 3D camera, will be assessed and compared between the facial side treated with injectable platelet-rich fibrin (i-PRF) and the contralateral facial side treated with intradermal tranexamic acid.
Measured: Baseline and Day 90
Physician Global Assessment of Improvement
Improvement in melasma at Day 90 will be assessed using Physician Global Assessment (PGA) based on standardized global photographs reviewed by 2 blinded dermatologists. Improvement will be categorized as excellent (>75%), marked (50% to 75%), good (25% to 49%), fair (<25%), or no response.
Measured: Day 90
Change in Melasma Quality of Life (MelasQoL) Score
Change in Melasma Quality of Life (MelasQoL) score from baseline to Day 90 will be assessed and compared between treatment conditions in participants with facial melasma.
Measured: Baseline and Day 90
Incidence of Treatment-Emergent Adverse Events
Incidence of adverse events during the study period will be assessed, including pain, tenderness, erythema, swelling, infection, pigmentation changes, ecchymosis, and hematoma, and will be compared between the facial side treated with injectable platelet-rich fibrin (i-PRF) and the contralateral facial side treated with intradermal tranexamic acid.
Measured: Up to Day 90
Patient Satisfaction at Day 90
Participant satisfaction with treatment outcome at Day 90 will be assessed and categorized as highly satisfied, moderately satisfied, partially satisfied, or not satisfied.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Feb 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (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
- Model description
- This is a randomized split-face, within-participant controlled trial. In each participant, one side of the face is randomly assigned to receive injectable platelet-rich fibrin (i-PRF) and the contralateral side is assigned to receive intradermal tranexamic acid. Both interventions are administered during the same study period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba ahmed abdelgayed ibrahim, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540702
- Sponsor's protocol ID
- MS-654-2025
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a single-center study with a small sample size, and de-identification cannot be fully guaranteed. Aggregate results, including summary statistics and outcome analyses, will be made available through publication
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy and Safety of Injectable Platelet-Rich Fibrin Versus Intradermal Tranexamic Acid in the Treatment of Melasma: A Randomized Split-Face Study
- ClinicalTrials.gov ID
- NCT07540702
- Acronym / sponsor ID
- MS-654-2025
- Conditions
- Melasma, Facial Melasma
- Keywords
- Injectable platelet-rich fibrin, i-PRF, Tranexamic acid, Melasma, Split-face study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 20 Apr 2026 (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 a chronic acquired hyperpigmentation disorder that commonly affects the face and has a significant impact on quality of life. Available treatments may improve pigmentation, but relapse is common and response can be variable.
This randomized split-face interventional study aims to compare the efficacy and safety of injectable platelet-rich fibrin (i-PRF) versus intradermal tranexamic acid (TA) in the treatment of facial melasma. Adult female patients with bilateral symmetrical facial melasma will be enrolled. In each participant, one side of the face will be randomly assigned to receive i-PRF and the contralateral side will receive intradermal TA.
Patients will undergo five treatment sessions at 2-week intervals. Clinical response will be assessed using the modified Melasma Area and Severity Index (mMASI), Antera 3D camera measurements, Physician Global Assessment, patient satisfaction, and Melasma Quality of Life (MelasQoL) questionnaire. Safety will be evaluated by recording adverse events such as pain, tenderness, erythema, swelling, infection, ecchymosis, and hematoma.
The study is designed to determine whether i-PRF is an effective and safe treatment option for melasma compared with intradermal tranexamic acid.
Detailed description
Melasma is a common chronic hyperpigmentation disorder characterized by symmetric brown to gray-brown patches, most commonly affecting the face. It is more frequent in women and in individuals with darker skin phototypes, and it may significantly impair psychosocial well-being and quality of life. Multiple pathogenic mechanisms have been implicated, including ultraviolet exposure, hormonal influences, genetic predisposition, melanocyte hyperactivity, and dermal vascular and inflammatory changes.
Current melasma therapies include topical depigmenting agents, chemical peels, laser and light-based procedures, and oral or local tranexamic acid. However, treatment response is often incomplete and recurrence is common. Intradermal tranexamic acid has shown promising results in reducing pigmentation through inhibition of plasmin activity and downstream melanocyte stimulation.
Injectable platelet-rich fibrin (i-PRF) is a second-generation autologous platelet concentrate prepared without anticoagulants. It provides a fibrin scaffold and gradual release of growth factors. Based on its biologic activity, i-PRF may have a therapeutic role in melasma by modulating melanogenesis, oxidative stress, and tissue repair. Despite this rationale, clinical evidence for i-PRF in melasma remains limited.
This study is a randomized split-face clinical trial designed to compare the efficacy and safety of i-PRF versus intradermal tranexamic acid in the treatment of facial melasma. Twenty-one adult female patients with mild to moderate bilateral symmetrical facial melasma, aged 18 to 50 years and with Fitzpatrick skin types III to IV, will be recruited from the outpatient dermatology clinic and cosmetology unit of Kasr El Ainy Hospital, Cairo University, Cairo, Egypt.
For each participant, one side of the face will be randomly assigned to receive i-PRF, while the contralateral side will receive intradermal tranexamic acid. Injectable platelet-rich fibrin (i-PRF) will be prepared from 10 mL of venous blood collected under aseptic conditions in a plain plastic tube and centrifuged at 60 g (700 rpm) for 3 minutes. The resulting i-PRF will be injected intradermally on the randomized side after topical anesthetic application. The opposite side will receive intradermal tranexamic acid prepared under aseptic conditions and injected at 1 cm intervals into melasma lesions. Participants will receive five treatment sessions at 2-week intervals. They will also be instructed to use broad-spectrum sunscreen and to avoid other topical facial treatments during the study period.
Both participants and outcome assessors will be blinded to the treatment allocation. Assessment will be performed at baseline and at the end of the study (Day 90). The primary outcome is the percent change in modified Melasma Area and Severity Index (mMASI) score from baseline to Day 90 between the i-PRF-treated side and the tranexamic-acid-treated side. Secondary outcomes include change in melanin level and vascular features measured by Antera 3D camera, Physician Global Assessment, patient satisfaction, global improvement scale, Melasma Quality of Life (MelasQoL) score, and adverse events.
Potential adverse effects include pain, tenderness, erythema, swelling, infection, ecchymosis, hematoma, and pigmentation changes. The study aims to determine whether i-PRF is an effective and safe therapeutic option for melasma compared with intradermal tranexamic acid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized split-face, within-participant controlled trial. In each participant, one side of the face is randomly assigned to receive injectable platelet-rich fibrin (i-PRF) and the contralateral side is assigned to receive intradermal tranexamic acid. Both interventions are administered during the same study period.
| Arm | Type | Receives |
|---|---|---|
| Injectable Platelet-Rich Fibrin Side | Experimental | Biological: Injectable Platelet-Rich FibrinIn this randomized split-face study, one side of each participant's face is randomly assigned to receive injectable platelet-rich fibrin (i-PRF). i-PRF is prepared from autologous venous blood and injected intradermally on the assigned side after topical anesthetic. Participants receive 5 treatment sessions at 2-week intervals. |
| Intradermal Tranexamic Acid Side | Active comparator | Drug: Tranexamic acid 100 mg/mL (Kapron)In this randomized split-face study, the contralateral side of each participant's face receives intradermal tranexamic acid after topical anesthetic. Tranexamic acid is prepared under aseptic conditions and injected intradermally into melasma lesions. Participants receive 5 treatment sessions at 2-week intervals. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of bilateral symmetrical facial melasma (epidermal or mixed type)
- Female participants aged 18 to 50 years
- Fitzpatrick skin types III to IV
- Mild to moderate facial melasma
- No melasma-specific treatment within the previous 4 weeks
Key exclusion criteria (6 listed)
- Pregnancy or lactation
- Bleeding or coagulation disorders
- Use of anticoagulants, nonsteroidal anti-inflammatory drugs (NSAIDs), or hormonal contraception
- Active skin infection or facial inflammation
- History of keloids or Koebner-prone conditions, such as psoriasis or vitiligo
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 |
|---|---|---|
| Injectable Platelet-Rich FibrinInjectable platelet-rich fibrin (i-PRF) is prepared from 10 mL of autologous venous blood collected in a plain plastic tube without additives and centrifuged at 60 g (700 rpm) for 3 minutes. The resulting fluid is aspirated immediately and injected intradermally on the randomized side of the face at a dose of 0.1 mL/cm² at 1-cm intervals using a 30-gauge insulin syringe. Five treatment sessions are administered at 2-week intervals. | Biological | Injectable Platelet-Rich Fibrin Side |
| Tranexamic acid 100 mg/mL (Kapron)Tranexamic acid (Kapron ampoules, 100 mg/mL) is diluted under aseptic conditions to a final concentration of 10 mg/mL by adding 0.1 mL of tranexamic acid to normal saline to a total volume of 1 mL. After topical anesthetic application, approximately 1 mL of the prepared 10 mg/mL solution is injected intradermally into melasma lesions on the contralateral side of the face at 1-cm intervals using a 30-gauge insulin syringe. Five treatment sessions are administered at 2-week intervals. | Drug | Intradermal Tranexamic Acid Side |
Primary outcome
Percent Change in Modified Melasma Area and Severity Index (mMASI) Score
Time frame: Baseline and Day 90
The percent change in modified Melasma Area and Severity Index (mMASI) score from baseline to Day 90 will be assessed and compared between the facial side treated with injectable platelet-rich fibrin (i-PRF) and the contralateral facial side treated with intradermal tranexamic acid.
6 secondary outcomes
Change in Melanin Level Measured by Antera 3D Camera
Time frame: Baseline and Day 90
Change in Vascular Features Measured by Antera 3D Camera
Time frame: Baseline and Day 90
Physician Global Assessment of Improvement
Time frame: Day 90
Change in Melasma Quality of Life (MelasQoL) Score
Time frame: Baseline and Day 90
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to Day 90
Patient Satisfaction at Day 90
Time frame: Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a single-center study with a small sample size, and de-identification cannot be fully guaranteed. Aggregate results, including summary statistics and outcome analyses, will be made available through publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable Platelet-Rich Fibrin and Tranexamic acid 100 mg/mL (Kapron) in people with Melasma and Facial Melasma, run by Kasr El Aini Hospital at 1 site in Egypt.
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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. 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 Egypt. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heba Ahmed (+201016532351, heba.a.abdelgayed@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Modified Melasma Area and Severity Index (mMASI) Score (time frame: Baseline and Day 90). 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 Apr 2026.