Melasma (Facial Melasma)Phase 4NCT07696806
Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma
A Phase 4 study testing Metformin 30% Topical Lotion, Tranexamic Acid 0.5% Topical Solution and Modified Kligman's Formula in people with Melasma (Facial Melasma), run by Sameh Sarsik at 1 site in Egypt.
Trial summary
Melasma is a common skin condition characterized by brown or gray patches on sun-exposed areas of the face. Although several topical treatments are available, treatment outcomes are often unsatisfactory, and recurrence is common. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Melasma (Facial Melasma)
- What is being tested?
- Metformin 30% Topical Lotion, Tranexamic Acid 0.5% Topical Solution and Modified Kligman's Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2026to 30 Aug 2027
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 18 years or older.
- Clinical diagnosis of melasma.
- No medical treatment for melasma during the previous 6 months.
- Willing and able to comply with all study procedures and follow-up visits.
- Provided written informed consent before study participation.
Who cannot join
- Pregnant or breastfeeding women.
- Use of hormonal contraceptives.
- Use of medications known to affect skin pigmentation (e.g., phenytoin, amiodarone, antipsychotics, cytotoxic agents, tetracyclines, or heavy metals).
- History of keloid formation or foreign body reaction.
- Known allergy or hypersensitivity to any study medication.
- Presence of systemic diseases affecting pigmentation, including hepatic, renal, thyroid, or other endocrine disorders.
- Fitzpatrick skin types V or VI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Microneedling-Assisted Delivery of Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma Treatment: A Clinical and Microscopic Evaluation
Melasma is a common skin condition characterized by brown or gray patches on sun-exposed areas of the face. Although several topical treatments are available, treatment outcomes are often unsatisfactory, and recurrence is common. This randomized, parallel-group clinical trial aims to compare the efficacy and safety of microneedling-assisted topical metformin, topical tranexamic acid, and modified Kligman's formula with microneedling-assisted saline in adult women with melasma. Eighty participants will be randomly assigned to one of four treatment groups. The primary outcome is the change in Melasma Area and Severity Index (MASI) score from baseline to the end of follow-up. Secondary outcomes include clinical improvement, dermoscopic changes in pigmentation and vascular features, patient satisfaction, and treatment-related adverse events.
Read the detailed description
Melasma is a chronic acquired hyperpigmentation disorder characterized by symmetric brown to gray-brown macules and patches affecting sun-exposed areas of the skin, particularly the face. It predominantly affects women of reproductive age and has a considerable negative impact on quality of life. The pathogenesis of melasma is multifactorial, involving genetic predisposition, ultraviolet radiation, hormonal influences, increased melanogenesis, vascular alterations, and inflammatory pathways. Despite the availability of multiple treatment options, recurrence is common and no universally effective therapy has been established.
Microneedling is a minimally invasive procedure that enhances transdermal drug delivery by creating controlled microchannels within the skin, thereby improving the penetration and bioavailability of topical agents. Topical metformin has recently emerged as a potential depigmenting agent through inhibition of melanogenesis and reduction of tyrosinase activity. Tranexamic acid inhibits ultraviolet-induced melanogenesis by suppressing the plasminogen-plasmin pathway and reducing melanocyte activation. Modified Kligman's formula, consisting of hydroquinone, tretinoin, and a topical corticosteroid, remains the standard topical treatment for melasma but is frequently associated with local adverse effects.
This prospective, randomized, parallel-group clinical trial was designed to compare the efficacy and safety of microneedling-assisted topical metformin, topical tranexamic acid, modified Kligman's formula, and saline as a control in women with melasma. Eighty eligible participants were randomly allocated in a 1:1:1:1 ratio to one of four treatment groups. All participants underwent standardized microneedling using a dermapen before application of the assigned topical treatment. Treatment sessions were performed every two weeks for a maximum of five sessions, followed by a three-month follow-up period.
The primary objective was to evaluate changes in the Melasma Area and Severity Index (MASI). Secondary objectives included assessment of clinical improvement, dermoscopic changes in pigmentation and vascular features, patient satisfaction, and treatment-related adverse events. The findings of this study are expected to provide comparative evidence regarding the effectiveness and safety of these microneedling-assisted topical therapies and help optimize treatment strategies for patients with melasma.
- Conditions
- Melasma (Facial Melasma)
- Being tested
- Metformin 30% Topical Lotion, Tranexamic Acid 0.5% Topical Solution, Modified Kligman's Formula, Normal Saline
- Keywords
- Melasma, Microneedling, Metformin, Tranexamic Acid, Modified Kligman's Formula, Hydroquinone
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin 30% Topical LotionDrug
Participants received topical metformin 30% lotion immediately after standardized microneedling with a dermapen. Approximately 3 mL of the lotion was applied during each treatment session. Five treatment sessions were performed at 2-week intervals. Participants were instructed to leave the medication on the skin for 4 hours before washing.
Tranexamic Acid 0.5% Topical SolutionDrug
Participants received topical tranexamic acid 0.5% solution immediately after standardized microneedling with a dermapen. Approximately 3 mL of the solution was applied during each treatment session. Five treatment sessions were performed at 2-week intervals. Participants were instructed to leave the medication on the skin for 4 hours before washing.
Modified Kligman's FormulaDrug
Participants received modified Kligman's formula consisting of hydroquinone 4%, tretinoin 0.05%, and mometasone furoate 0.1% immediately after standardized microneedling with a dermapen. Approximately 3 mL was applied during each treatment session. Five treatment sessions were performed at 2-week intervals. Participants were instructed to leave the medication on the skin for 4 hours before washing.
Normal SalineDrug
Participants received topical normal saline immediately after standardized microneedling with a dermapen. Approximately 3 mL of saline was applied during each treatment session. Five treatment sessions were performed at 2-week intervals. Participants were instructed to leave the saline on the skin for 4 hours before washing.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling + Topical Metformin | Experimental | Participants underwent standardized microneedling using a dermapen followed by topical application of 3 mL of 30% metformin lotion during each treatment session. Five treatment sessions were performed at 2-week intervals. Receives: Drug: Metformin 30% Topical Lotion |
| Microneedling + Topical Tranexamic Acid | Experimental | Participants underwent standardized microneedling using a dermapen followed by topical application of 3 mL of 0.5% tranexamic acid solution during each treatment session. Five treatment sessions were performed at 2-week intervals. Receives: Drug: Tranexamic Acid 0.5% Topical Solution |
| Microneedling + Modified Kligman's Formula | Experimental | Participants underwent standardized microneedling using a dermapen followed by topical application of modified Kligman's formula (hydroquinone 4%, tretinoin 0.05%, and mometasone furoate 0.1%) during each treatment session. Five treatment sessions were performed at 2-week intervals. Receives: Drug: Modified Kligman's Formula |
| Microneedling + Saline | Experimental | Participants underwent standardized microneedling using a dermapen followed by topical application of 3 mL of normal saline during each treatment session. Five treatment sessions were performed at 2-week intervals. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Melasma Area and Severity Index (MASI) Score
MASI score mean difference before minus after will be calculated to detect the highest change or improvement
Measured: Baseline to 3 months after the final treatment session (approximately 5 months after randomization)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
the adverse effects associated with each treatment
Measured: Baseline to 3 months after the final treatment session (approximately 5 months after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melasma (Facial Melasma)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1:1:1 ratio to one of four parallel treatment groups. All participants underwent standardized microneedling with a dermapen before receiving the assigned topical intervention: 30% metformin lotion, 0.5% tranexamic acid solution, modified Kligman's formula, or saline (control). Treatment consisted of five sessions performed at 2-week intervals, followed by a 3-month follow-up period to evaluate efficacy and safety.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sameh Sarsik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sameh Sarsik, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696806
- Sponsor's protocol ID
- TU-DERM-MEL-2020-001
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 28 Jul 2026
- 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling-Assisted Delivery of Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma Treatment: A Clinical and Microscopic Evaluation
- ClinicalTrials.gov ID
- NCT07696806
- Acronym / sponsor ID
- TU-DERM-MEL-2020-001
- Conditions
- Melasma (Facial Melasma)
- Keywords
- Melasma, Microneedling, Metformin, Tranexamic Acid, Modified Kligman's Formula, Hydroquinone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sameh SarsikUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 10 Jul 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 common skin condition characterized by brown or gray patches on sun-exposed areas of the face. Although several topical treatments are available, treatment outcomes are often unsatisfactory, and recurrence is common. This randomized, parallel-group clinical trial aims to compare the efficacy and safety of microneedling-assisted topical metformin, topical tranexamic acid, and modified Kligman's formula with microneedling-assisted saline in adult women with melasma. Eighty participants will be randomly assigned to one of four treatment groups. The primary outcome is the change in Melasma Area and Severity Index (MASI) score from baseline to the end of follow-up. Secondary outcomes include clinical improvement, dermoscopic changes in pigmentation and vascular features, patient satisfaction, and treatment-related adverse events.
Detailed description
Melasma is a chronic acquired hyperpigmentation disorder characterized by symmetric brown to gray-brown macules and patches affecting sun-exposed areas of the skin, particularly the face. It predominantly affects women of reproductive age and has a considerable negative impact on quality of life. The pathogenesis of melasma is multifactorial, involving genetic predisposition, ultraviolet radiation, hormonal influences, increased melanogenesis, vascular alterations, and inflammatory pathways. Despite the availability of multiple treatment options, recurrence is common and no universally effective therapy has been established.
Microneedling is a minimally invasive procedure that enhances transdermal drug delivery by creating controlled microchannels within the skin, thereby improving the penetration and bioavailability of topical agents. Topical metformin has recently emerged as a potential depigmenting agent through inhibition of melanogenesis and reduction of tyrosinase activity. Tranexamic acid inhibits ultraviolet-induced melanogenesis by suppressing the plasminogen-plasmin pathway and reducing melanocyte activation. Modified Kligman's formula, consisting of hydroquinone, tretinoin, and a topical corticosteroid, remains the standard topical treatment for melasma but is frequently associated with local adverse effects.
This prospective, randomized, parallel-group clinical trial was designed to compare the efficacy and safety of microneedling-assisted topical metformin, topical tranexamic acid, modified Kligman's formula, and saline as a control in women with melasma. Eighty eligible participants were randomly allocated in a 1:1:1:1 ratio to one of four treatment groups. All participants underwent standardized microneedling using a dermapen before application of the assigned topical treatment. Treatment sessions were performed every two weeks for a maximum of five sessions, followed by a three-month follow-up period.
The primary objective was to evaluate changes in the Melasma Area and Severity Index (MASI). Secondary objectives included assessment of clinical improvement, dermoscopic changes in pigmentation and vascular features, patient satisfaction, and treatment-related adverse events. The findings of this study are expected to provide comparative evidence regarding the effectiveness and safety of these microneedling-assisted topical therapies and help optimize treatment strategies for patients with melasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants were randomly assigned in a 1:1:1:1 ratio to one of four parallel treatment groups. All participants underwent standardized microneedling with a dermapen before receiving the assigned topical intervention: 30% metformin lotion, 0.5% tranexamic acid solution, modified Kligman's formula, or saline (control). Treatment consisted of five sessions performed at 2-week intervals, followed by a 3-month follow-up period to evaluate efficacy and safety.
| Arm | Type | Receives |
|---|---|---|
| Microneedling + Topical Metformin | Experimental | Drug: Metformin 30% Topical LotionParticipants underwent standardized microneedling using a dermapen followed by topical application of 3 mL of 30% metformin lotion during each treatment session. Five treatment sessions were performed at 2-week intervals. |
| Microneedling + Topical Tranexamic Acid | Experimental | Drug: Tranexamic Acid 0.5% Topical SolutionParticipants underwent standardized microneedling using a dermapen followed by topical application of 3 mL of 0.5% tranexamic acid solution during each treatment session. Five treatment sessions were performed at 2-week intervals. |
| Microneedling + Modified Kligman's Formula | Experimental | Drug: Modified Kligman's FormulaParticipants underwent standardized microneedling using a dermapen followed by topical application of modified Kligman's formula (hydroquinone 4%, tretinoin 0.05%, and mometasone furoate 0.1%) during each treatment session. Five treatment sessions were performed at 2-week intervals. |
| Microneedling + Saline | Experimental | Drug: Normal SalineParticipants underwent standardized microneedling using a dermapen followed by topical application of 3 mL of normal saline during each treatment session. Five treatment sessions were performed at 2-week intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female participants aged 18 years or older.
- Clinical diagnosis of melasma.
- No medical treatment for melasma during the previous 6 months.
- Willing and able to comply with all study procedures and follow-up visits.
- Provided written informed consent before study participation.
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women.
- Use of hormonal contraceptives.
- Use of medications known to affect skin pigmentation (e.g., phenytoin, amiodarone, antipsychotics, cytotoxic agents, tetracyclines, or heavy metals).
- History of keloid formation or foreign body reaction.
- Known allergy or hypersensitivity to any study medication.
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 |
|---|---|---|
| Metformin 30% Topical LotionParticipants received topical metformin 30% lotion immediately after standardized microneedling with a dermapen. Approximately 3 mL of the lotion was applied during each treatment session. Five treatment sessions were performed at 2-week intervals. Participants were instructed to leave the medication on the skin for 4 hours before washing. | Drug | Microneedling + Topical Metformin |
| Tranexamic Acid 0.5% Topical SolutionParticipants received topical tranexamic acid 0.5% solution immediately after standardized microneedling with a dermapen. Approximately 3 mL of the solution was applied during each treatment session. Five treatment sessions were performed at 2-week intervals. Participants were instructed to leave the medication on the skin for 4 hours before washing. | Drug | Microneedling + Topical Tranexamic Acid |
| Modified Kligman's FormulaParticipants received modified Kligman's formula consisting of hydroquinone 4%, tretinoin 0.05%, and mometasone furoate 0.1% immediately after standardized microneedling with a dermapen. Approximately 3 mL was applied during each treatment session. Five treatment sessions were performed at 2-week intervals. Participants were instructed to leave the medication on the skin for 4 hours before washing. | Drug | Microneedling + Modified Kligman's Formula |
| Normal SalineParticipants received topical normal saline immediately after standardized microneedling with a dermapen. Approximately 3 mL of saline was applied during each treatment session. Five treatment sessions were performed at 2-week intervals. Participants were instructed to leave the saline on the skin for 4 hours before washing. | Drug | Microneedling + Saline |
Primary outcome
Change in Melasma Area and Severity Index (MASI) Score
Time frame: Baseline to 3 months after the final treatment session (approximately 5 months after randomization)
MASI score mean difference before minus after will be calculated to detect the highest change or improvement
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Baseline to 3 months after the final treatment session (approximately 5 months after randomization)
the adverse effects associated with each treatment
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 28 Jul 2026.
- 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.
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 Phase 4 study testing Metformin 30% Topical Lotion, Tranexamic Acid 0.5% Topical Solution and Modified Kligman's Formula in people with Melasma (Facial Melasma), run by Sameh Sarsik 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 5 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 28 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Change in Melasma Area and Severity Index (MASI) Score (time frame: Baseline to 3 months after the final treatment session (approximately 5 months after randomization)). The study lists 2 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 28 Jul 2026.