FemaleNCT07887399
New Treatment in Melasma
A study testing Tranexamic Acid - topical, Microneedling with Topical Tranexamic acid and Modified Kligman's Formula in people with Female and With, run by Sohag University at 1 site in Egypt.
Trial summary
This randomized controlled trial aims to compare different therapeutic approaches for the treatment of melasma. Participants will be randomly allocated into three treatment groups receiving modified Kligman formula, microneedling-assisted topical tranexamic acid, or nanotechnology-based topical tranexamic acid. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- What is being tested?
- Tranexamic Acid - topical, Microneedling with Topical Tranexamic acid and Modified Kligman's Formula
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Oct 2026to 18 Jun 2027
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult females≥18 years
- All types of Melasma of any severity (epidermal, dermal and mixed)
- Fitzpatrick skin types II-V
Who cannot join
- - Recent treatment of Melasma (3months before enrollement in the study)
- Pregnancy and lactation
- Scarring or Keloidal tendency
- Active infection
- Medical treatment including: hormonal therapy, anticoagulant, antiplatelet and photosensitizing drugs
- Systemic diseases including: DM, HTN, Malignancy and bleeding disorders
- Other causes of hyperpigmentation
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: Efficacy and Safety of Topical Nanotechnology-based, Versus Microneedling-assisted Tranexamic Acid in Treatment of Melasma: A Randomized Controlled Trial
This randomized controlled trial aims to compare different therapeutic approaches for the treatment of melasma.
Participants will be randomly allocated into three treatment groups receiving modified Kligman formula, microneedling-assisted topical tranexamic acid, or nanotechnology-based topical tranexamic acid.
The study will compare these treatment approaches over a defined treatment period followed by a follow-up period.
The study will provide evidence regarding the comparative efficacy and safety of these therapeutic modalities in patients with melasma.
- Being tested
- Tranexamic Acid - topical, Microneedling with Topical Tranexamic acid, Modified Kligman's Formula
- Keywords
- Melasma, Tranexamic acid, Microneedling, Nano-based Technology
- Medical subject headings
- Facies, Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid - topicalDrug
Also called Nanotechnology-based Tranexamic Acid
Group A: will use daily topical TXA 3% +ZnO suspension (Nano-based Technology) on the entire face 2 times per day. Nanotechnology based formulations are able to overcome skin barrier so the drug will be retained in the epidermis to target melanocytes
Microneedling with Topical Tranexamic acidProcedure or surgery
Also called Microneedling-assisted topical TXA
Group B: will undergo microneedling over the face for a maximum 4 sessions with a 4-week interval between each session followed by topical TXA gel 3% after session and on daily basis over entire face 2 times per day. Microneedling will be done using (Derma Pen Maglev 3,Germany) with a 32-needle head with a needle depth ranging from 0.25 to 1 mm and adjusted according to the thickness and anatomical site of facial skin
Modified Kligman's FormulaDrug
Group C: will use modified Kligman formula every night.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Nanotechnology-based Topical Tranexamic Acid | Active comparator | Group A: will use daily topical TXA 3% +ZnO suspension (Nano-based Technology) on the entire face 2 times per day Receives: Drug: Tranexamic Acid - topical |
| Group B: Microneedling + Topical Tranexamic acid | Active comparator | Group B: will undergo microneedling over the face for a maximum 4 sessions with a 4-week interval between each session followed by topical TXA gel 3% after session and on daily basis over entire face 2 times per day. Microneedling will be done using (Derma Pen Maglev 3,Germany) with a 32-needle head with a needle depth ranging from 0.25 to 1 mm and adjusted according to the thickness and anatomical site of facial skin Receives: Procedure: Microneedling with Topical Tranexamic acid |
| Group C: Modified Kligman Formula | Active comparator | Group C: will use modified Kligman formula every night Receives: Drug: Modified Kligman's Formula |
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 from baseline to the end of the treatment period
The mean change in MASI score from baseline to the end of the treatment period (4 months) will be compared among the three treatment groups.
Measured: 4 months after initiation of treatment
Secondary outcomes (3)
Percentage change in Melasma Area and Severity Index (MASI) from baseline to the end of treatment
The percentage change in MASI score from Baseline to the end of the treatment period will be calculated for each participant and compared among the three treatment groups.
Measured: 4 months after initiation of treatment
Patient Satisfaction assessed using a 4-point patient satisfaction scale
Patient satisfaction with treatment results will be assessed at the end of the treatment period using a 4-point scale: excellent(>75% improvement), good(51-75% improvement), fair (26-50% improvement), and poor (0-25% improvement).
Measured: 4 months after initiation of treatment
Incidence of treatment-related adverse events
Treatment safety will be assessed by recording the incidence and types of adverse events, including erythema, irritation, burning, dryness and post-inflammatory hyperpigmentation
Measured: from initiation of treatment to the end of the treatment period(4months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start18 Oct 2026 (estimated)
- Primary completion18 Feb 2027 (estimated)
- Study completion18 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FemaleStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amera Gamal Thabet, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887399
- Sponsor's protocol ID
- Soh-Med-26-9-19MS
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Nanotechnology-based, Versus Microneedling-assisted Tranexamic Acid in Treatment of Melasma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07887399
- Acronym / sponsor ID
- Soh-Med-26-9-19MS
- Keywords
- Melasma, Tranexamic acid, Microneedling, Nano-based Technology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 18 Oct 2026 (estimated)
- Primary completion
- 18 Feb 2027 (estimated)
- Study completion
- 18 Jun 2027 (estimated)
- First posted
- 21 Oct 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.
This randomized controlled trial aims to compare different therapeutic approaches for the treatment of melasma.
Participants will be randomly allocated into three treatment groups receiving modified Kligman formula, microneedling-assisted topical tranexamic acid, or nanotechnology-based topical tranexamic acid.
The study will compare these treatment approaches over a defined treatment period followed by a follow-up period.
The study will provide evidence regarding the comparative efficacy and safety of these therapeutic modalities in patients with melasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Nanotechnology-based Topical Tranexamic Acid | Active comparator | Drug: Tranexamic Acid - topicalGroup A: will use daily topical TXA 3% +ZnO suspension (Nano-based Technology) on the entire face 2 times per day |
| Group B: Microneedling + Topical Tranexamic acid | Active comparator | Procedure: Microneedling with Topical Tranexamic acidGroup B: will undergo microneedling over the face for a maximum 4 sessions with a 4-week interval between each session followed by topical TXA gel 3% after session and on daily basis over entire face 2 times per day. Microneedling will be done using (Derma Pen Maglev 3,Germany) with a 32-needle head with a needle depth ranging from 0.25 to 1 mm and adjusted according to the thickness and anatomical site of facial skin |
| Group C: Modified Kligman Formula | Active comparator | Drug: Modified Kligman's FormulaGroup C: will use modified Kligman formula every night |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult females≥18 years
- All types of Melasma of any severity (epidermal, dermal and mixed)
- Fitzpatrick skin types II-V
Key exclusion criteria (7 listed)
- - Recent treatment of Melasma (3months before enrollement in the study)
- Pregnancy and lactation
- Scarring or Keloidal tendency
- Active infection
- Medical treatment including: hormonal therapy, anticoagulant, antiplatelet and photosensitizing drugs
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 Acid - topicalAlso: Nanotechnology-based Tranexamic AcidGroup A: will use daily topical TXA 3% +ZnO suspension (Nano-based Technology) on the entire face 2 times per day. Nanotechnology based formulations are able to overcome skin barrier so the drug will be retained in the epidermis to target melanocytes | Drug | Group A: Nanotechnology-based Topical Tranexamic Acid |
| Microneedling with Topical Tranexamic acidAlso: Microneedling-assisted topical TXAGroup B: will undergo microneedling over the face for a maximum 4 sessions with a 4-week interval between each session followed by topical TXA gel 3% after session and on daily basis over entire face 2 times per day. Microneedling will be done using (Derma Pen Maglev 3,Germany) with a 32-needle head with a needle depth ranging from 0.25 to 1 mm and adjusted according to the thickness and anatomical site of facial skin | Procedure or surgery | Group B: Microneedling + Topical Tranexamic acid |
| Modified Kligman's FormulaGroup C: will use modified Kligman formula every night. | Drug | Group C: Modified Kligman Formula |
Primary outcome
Change in Melasma Area and Severity Index (MASI) score from baseline to the end of the treatment period
Time frame: 4 months after initiation of treatment
The mean change in MASI score from baseline to the end of the treatment period (4 months) will be compared among the three treatment groups.
3 secondary outcomes
Percentage change in Melasma Area and Severity Index (MASI) from baseline to the end of treatment
Time frame: 4 months after initiation of treatment
Patient Satisfaction assessed using a 4-point patient satisfaction scale
Time frame: 4 months after initiation of treatment
Incidence of treatment-related adverse events
Time frame: from initiation of treatment to the end of the treatment period(4months)
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 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 Tranexamic Acid - topical, Microneedling with Topical Tranexamic acid and Modified Kligman's Formula in people with Female and With, run by Sohag University 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 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 21 Oct 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 Amira Gamal Thabet, Resident doctor (201124712921, mirothabet9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Melasma Area and Severity Index (MASI) score from baseline to the end of the treatment period (time frame: 4 months after initiation of treatment). 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 21 Oct 2026.