MelasmaPhase 4NCT07732192
Oral Tranexamic Acid Plus Triple Combination vs Triple Combination Alone in Melasma
A Phase 4 study testing Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) and Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone in people with Melasma and Melasma (Facial Melasma), run by Combined Military Hospital Abbottabad.
Trial summary
The data will be collected after the permission of the ethical committee of hospital. Following the enrollment, patients will be selected by lottery in the two equal groups. Group A will be administered with oral tranexamic acid and triple combination therapy whereas Group B will be treated with triple combination… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Melasma, Melasma (Facial Melasma)
- What is being tested?
- Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) and Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 1 Feb 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria: Patients aged 18 to 50 years of either gender with clinically diagnosed epidermal or mixed melasma of at least six months duration and baseline MASI score above the predefined threshold will be included. Patients willing to comply with treatment and follow-up schedule will be enrolled.
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Exclusion Criteria: Patients with dermal melasma, pregnancy, lactation, history of thromboembolic disease, coagulation disorders, current hormonal therapy use, recent treatment for melasma, hypersensitivity to study medications, or significant hepatic or renal disease will be excluded.
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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: Comparative Efficacy of Oral Tranexamic Acid With Triple Combination (Fluocinolone+ Hydroquinone +Tretinoin) Versus Triple Combination Alone in Melasma in a Tertiary Care Hospital
The data will be collected after the permission of the ethical committee of hospital. Following the enrollment, patients will be selected by lottery in the two equal groups. Group A will be administered with oral tranexamic acid and triple combination therapy whereas Group B will be treated with triple combination therapy. Strict use of sunscreens and sun protection will be promoted to all patients. Group A will administer oral tranexamic acid with the prescribed dose of the study drug along with topical application of fluocinolone acetonide, hydroquinone and tretinoin at bedtime. Group B will be treated by triple combination therapy only once a day at night. The study will continue to treatment. There will be a baseline MASI score which will be taken prior to the onset of treatment and re-evaluated at the planned follow-ups. The main outcome will be the decrease in the MASI score and the percentage of the patients who will be responding to treatment. The negative effects and recurrence in the follow-up will be considered as secondary outcomes. The structured proforma will gather data on age, gender, melasma duration, skin phototype, baseline MASI score, treatment group, follow-up MASI score, percentage improvement, adverse effects and treatment response. The principal investigator will document all the findings.
- Conditions
- Melasma, Melasma (Facial Melasma)
- Being tested
- Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin), Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone
- Keywords
- Tranexamic Acid, MASI Score, Melasma, Triple Combination Therapy
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin)Combination product
Participants will receive oral tranexamic acid in combination with topical triple combination cream (fluocinolone acetonide, hydroquinone, and tretinoin) for the treatment of melasma. The efficacy and safety of this combined therapy will be evaluated and compared with triple combination cream alone.
Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) aloneDrug
Participants will receive topical triple combination cream containing fluocinolone acetonide, hydroquinone, and tretinoin alone as standard therapy for the treatment of melasma. Its efficacy and safety will be compared with the combination therapy including oral tranexamic acid.
| Study group | Role | What they receive |
|---|---|---|
| Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) | Experimental | Not described Receives: Combination Product: Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) |
| Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone | Active comparator | Not described Receives: Drug: Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
MASI Score
Change in Melasma Area and Severity Index (MASI) score from baseline to the end of treatment period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion14 Jan 2027 (estimated)
- Study completion1 Feb 2027 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Abbottabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kiran Nawaz Jadoon, Combined Military Hospital Abbottabad
- Investigators
- Ali Amar, MBBS, FCPS, CHPE, Study chair, Combined Military Hospital Abbottabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732192
- Sponsor's protocol ID
- CMH-Atd-ETH-234-Derma-2026
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to privacy and confidentiality considerations. Only aggregated study results may be reported or published.
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
- Comparative Efficacy of Oral Tranexamic Acid With Triple Combination (Fluocinolone+ Hydroquinone +Tretinoin) Versus Triple Combination Alone in Melasma in a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT07732192
- Acronym / sponsor ID
- CMH-Atd-ETH-234-Derma-2026
- Conditions
- Melasma, Melasma (Facial Melasma)
- Keywords
- Tranexamic Acid, MASI Score, Melasma, Triple Combination Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Combined Military Hospital AbbottabadUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 14 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 28 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.
The data will be collected after the permission of the ethical committee of hospital. Following the enrollment, patients will be selected by lottery in the two equal groups. Group A will be administered with oral tranexamic acid and triple combination therapy whereas Group B will be treated with triple combination therapy. Strict use of sunscreens and sun protection will be promoted to all patients. Group A will administer oral tranexamic acid with the prescribed dose of the study drug along with topical application of fluocinolone acetonide, hydroquinone and tretinoin at bedtime. Group B will be treated by triple combination therapy only once a day at night. The study will continue to treatment. There will be a baseline MASI score which will be taken prior to the onset of treatment and re-evaluated at the planned follow-ups. The main outcome will be the decrease in the MASI score and the percentage of the patients who will be responding to treatment. The negative effects and recurrence in the follow-up will be considered as secondary outcomes. The structured proforma will gather data on age, gender, melasma duration, skin phototype, baseline MASI score, treatment group, follow-up MASI score, percentage improvement, adverse effects and treatment response. The principal investigator will document all the findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) | Experimental | Combination Product: Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) |
| Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone | Active comparator | Drug: Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin)Participants will receive oral tranexamic acid in combination with topical triple combination cream (fluocinolone acetonide, hydroquinone, and tretinoin) for the treatment of melasma. The efficacy and safety of this combined therapy will be evaluated and compared with triple combination cream alone. | Combination product | Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) |
| Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) aloneParticipants will receive topical triple combination cream containing fluocinolone acetonide, hydroquinone, and tretinoin alone as standard therapy for the treatment of melasma. Its efficacy and safety will be compared with the combination therapy including oral tranexamic acid. | Drug | Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone |
Primary outcome
MASI Score
Time frame: 6 months
Change in Melasma Area and Severity Index (MASI) score from baseline to the end of treatment period.
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. Individual participant data will not be made publicly available due to privacy and confidentiality considerations. Only aggregated study results may be reported or published.
Related trials for Melasma
Active, not recruitingPhase 4
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Melasma (Facial Melasma)
Not yet recruiting
COMPARISON OF TOPICAL VITAMIN C VS NIACINAMIDE IN TREATMENT OF MELASMA
Melasma
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Female, With
Not yet recruitingPhase 4
Baseline Dermoscopic Vascular Score and Response to Oral Tranexamic Acid in Facial Melasma
Melasma
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Melasma
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.
Ali Amar, MBBS, FCPS, CHPE study chair
Combined Military Hospital Abbottabad
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral tranexamic acid + triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) and Triple combination cream (fluocinolone acetonide + hydroquinone + tretinoin) alone in people with Melasma and Melasma (Facial Melasma), run by Combined Military Hospital Abbottabad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Jul 2026. 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 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?
Contact Kiran Nawaz Jadoon, MBBS (+923345806838, kiranjadoon27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MASI Score (time frame: 6 months). 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.