MelasmaPhase 2NCT06942390
Topical Metformin Versus Topical Ketotifen in Melasma Treatment
A Phase 2 study testing Micro-Needling Combined with ketofin and metformin and ketofin and metformin Alone in people with Melasma, run by Assiut University.
Trial summary
The study aims to evaluate and compare the efficacy and safety of a new formulation of topical metformin (nanoparticles) versus topical ketotifen (nanoparticles), both alone and combined with micro-needling, for the treatment of melasma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Melasma
- What is being tested?
- Micro-Needling Combined with ketofin and metformin and ketofin and metformin Alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Oct 2026
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female adults of 18 years and above with bilateral melasma .
- Clinical diagnosis of melasma.
- Mental capacity to give informed consent.
Who cannot join
- Pregnant or nursing women.
- Current use of hormonal birth control medication or any hormonal therapy.
- Current or previous treatment by depigmenting agents within 3 months
- History of laser or MN to the face within 3 months of study enrollment.
- Patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar/keloids.
- Photosensitivity.
- Patients with unrealistic expectations.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Topical Metfotmin Versus Topical Ketotifen (Alone or in Combination With Microneddling)in Melasma Treatment :Comparative Split Face Study
The study aims to evaluate and compare the efficacy and safety of a new formulation of topical metformin (nanoparticles) versus topical ketotifen (nanoparticles), both alone and combined with micro-needling, for the treatment of melasma. It is a double-blinded, randomized, split-face controlled clinical study involving 102 female patients diagnosed with bilateral melasma.
Read the detailed description
This research investigates the therapeutic effects of two nanoparticle-based topical treatments-metformin and ketotifen-on melasma. The study employs a split-face design where each patient receives different treatments on each half of their face. Patients are divided into two groups:
Group 1: Undergoes micro-needling sessions for the entire face, followed by the application of topical ketotifen on one half and topical metformin on the other half.
Group 2: Receives only topical applications of ketotifen on one half of the face and metformin on the other half without micro-needling.
The study includes detailed pre-procedure preparation (cleaning and anesthetizing the face) and post-procedure care (application of SPF 50+ sunblock). Clinical assessments include photographic documentation, H-MASI and mH-MASI scoring for melasma severity, patient satisfaction surveys, MELASQOL questionnaires to assess quality-of-life impacts, and monitoring for side effects. Assessments are conducted at baseline, monthly during treatment, and one month after the final session.
- Conditions
- Melasma
- Being tested
- Micro-Needling Combined with ketofin and metformin, ketofin and metformin Alone
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-Needling Combined with ketofin and metforminDevice
After micro-needling, topical ketotifen is applied to one half of the face and topical metformin to the other half. Between sessions, patients continue daily application of both treatments.
ketofin and metformin AloneDrug
Also called topical treatments
This arm includes 51 patients receiving daily applications of topical ketotifen on one half of their face and topical metformin on the other half without undergoing micro-needling sessions.
| Study group | Role | What they receive |
|---|---|---|
| Micro-Needling Combined with Topical Treatments | Experimental | This arm involves 51 patients receiving four sessions of micro-needling across their entire face at four-week intervals. After micro-needling, topical ketotifen is applied to one half of the face and topical metformin to the other half. Between sessions, patients continue daily application of both treatments. Receives: Device: Micro-Needling Combined with ketofin and metformin |
| topical Treatments Alone | Experimental | This arm includes 51 patients receiving daily applications of topical ketotifen on one half of their face and topical metformin on the other half without undergoing micro-needling sessions. Receives: Drug: ketofin and metformin Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Melasma Severity Index (MASI) Score
Measurement of changes in MASI score from baseline to the end of treatment (1 month). MASI is a validated tool used to assess the severity and area of melasma pigmentation, with lower scores indicating improvement.The Melasma Area and Severity Index (MASI) quantifies melasma severity using a 0-48 scale, where 0 = no melasma and 48 = maximum severity
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Khaled AbdElAziz, Assiut University
- Investigators
- Radwa Bakr, Assistant professor, Study director, Assiot university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942390
- Sponsor's protocol ID
- Melasma treatment
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Metfotmin Versus Topical Ketotifen (Alone or in Combination With Microneddling)in Melasma Treatment :Comparative Split Face Study
- ClinicalTrials.gov ID
- NCT06942390
- Acronym / sponsor ID
- Melasma treatment
- Conditions
- Melasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 24 Apr 2025 (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.
The study aims to evaluate and compare the efficacy and safety of a new formulation of topical metformin (nanoparticles) versus topical ketotifen (nanoparticles), both alone and combined with micro-needling, for the treatment of melasma. It is a double-blinded, randomized, split-face controlled clinical study involving 102 female patients diagnosed with bilateral melasma.
Detailed description
This research investigates the therapeutic effects of two nanoparticle-based topical treatments-metformin and ketotifen-on melasma. The study employs a split-face design where each patient receives different treatments on each half of their face. Patients are divided into two groups:
Group 1: Undergoes micro-needling sessions for the entire face, followed by the application of topical ketotifen on one half and topical metformin on the other half.
Group 2: Receives only topical applications of ketotifen on one half of the face and metformin on the other half without micro-needling.
The study includes detailed pre-procedure preparation (cleaning and anesthetizing the face) and post-procedure care (application of SPF 50+ sunblock). Clinical assessments include photographic documentation, H-MASI and mH-MASI scoring for melasma severity, patient satisfaction surveys, MELASQOL questionnaires to assess quality-of-life impacts, and monitoring for side effects. Assessments are conducted at baseline, monthly during treatment, and one month after the final session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro-Needling Combined with Topical Treatments | Experimental | Device: Micro-Needling Combined with ketofin and metforminThis arm involves 51 patients receiving four sessions of micro-needling across their entire face at four-week intervals. After micro-needling, topical ketotifen is applied to one half of the face and topical metformin to the other half. Between sessions, patients continue daily application of both treatments. |
| topical Treatments Alone | Experimental | Drug: ketofin and metformin AloneThis arm includes 51 patients receiving daily applications of topical ketotifen on one half of their face and topical metformin on the other half without undergoing micro-needling sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female adults of 18 years and above with bilateral melasma .
- Clinical diagnosis of melasma.
- Mental capacity to give informed consent.
Key exclusion criteria (7 listed)
- Pregnant or nursing women.
- Current use of hormonal birth control medication or any hormonal therapy.
- Current or previous treatment by depigmenting agents within 3 months
- History of laser or MN to the face within 3 months of study enrollment.
- Patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar/keloids.
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 |
|---|---|---|
| Micro-Needling Combined with ketofin and metforminAfter micro-needling, topical ketotifen is applied to one half of the face and topical metformin to the other half. Between sessions, patients continue daily application of both treatments. | Device | Micro-Needling Combined with Topical Treatments |
| ketofin and metformin AloneAlso: topical treatmentsThis arm includes 51 patients receiving daily applications of topical ketotifen on one half of their face and topical metformin on the other half without undergoing micro-needling sessions. | Drug | topical Treatments Alone |
Primary outcome
Reduction in Melasma Severity Index (MASI) Score
Time frame: 1 month
Measurement of changes in MASI score from baseline to the end of treatment (1 month). MASI is a validated tool used to assess the severity and area of melasma pigmentation, with lower scores indicating improvement.The Melasma Area and Severity Index (MASI) quantifies melasma severity using a 0-48 scale, where 0 = no melasma and 48 = maximum severity
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 24 Apr 2025.
- 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.
Radwa Bakr, Assistant professor study director
Assiot university
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Micro-Needling Combined with ketofin and metformin and ketofin and metformin Alone 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 3 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: opening soon, as of the sponsor's last update on 24 Apr 2025. 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?
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 Sara Khaled, Resident (01019420120, sarakhaled1098@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Melasma Severity Index (MASI) Score (time frame: 1 month). 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 24 Apr 2025.