AzTrials
AzTrials

Melasma (Facial Melasma)Phase 4NCT07893067

Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study

A Phase 4 study testing Group B (Triple Combination Cream + Microneedling + Platelet-Rich Plasma) in people with Melasma (Facial Melasma), run by Bangladesh Medical University at 1 site in Bangladesh.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Background Melasma is a chronic acquired pigmentary disorder characterized by symmetrical hyperpigmented macules and patches, predominantly affecting the face. It commonly occurs in individuals with darker skin phototypes and may significantly affect quality of life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melasma (Facial Melasma)
What is being tested?
Group B (Triple Combination Cream + Microneedling + Platelet-Rich Plasma)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBangladesh
Study dates
13 Oct 2026to 13 Nov 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged more than 18 years old. Patients with moderate to severe melasma diagnosed clinically and confirmed by dermoscopic examination if needed.
  • Patients who are willing to participate in the study and provide written informed consent.

Who cannot join

  • Patients with known case of hypersensitivity to tranexamic acid, triple-combination cream and or topical anesthetic agents (lidocaine, prilocaine).
  • Patients who received any treatment (topical/systemic/procedural) for melasma within 1 month prior to enrollment.
  • Patients with any active facial infection or facial dermatoses.
  • Pregnant or lactating women.
  • Women receiving hormone replacement therapy, oral contraceptive pills isotretinoin, systemic steroid, or any systemic drugs which causes facial pigmentation (eg. hydroxychloroquine, amiodarone, doxycycline, anti convulsants, anti malignant drugs).
  • Keloidal tendency.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • Department of Dermatology and venereology, BMU

    Dhaka, 1230

Other trials in Bangladesh

About this study

Official title: Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma

Background Melasma is a chronic acquired pigmentary disorder characterized by symmetrical hyperpigmented macules and patches, predominantly affecting the face. It commonly occurs in individuals with darker skin phototypes and may significantly affect quality of life. Triple-combination cream containing hydroquinone, tretinoin, and fluocinolone acetonide is an established treatment; however, response may be incomplete. Microneedling enhances transdermal drug delivery and promotes dermal remodeling. Tranexamic acid (TXA) inhibits melanogenesis, while platelet-rich plasma (PRP) contains growth factors that may promote dermal remodeling and modulate melanogenesis.

Objective To compare the efficacy and safety of triple-combination cream plus microneedling with TXA versus platelet-rich plasma in the treatment of moderate-to-severe melasma.

Read more

Methods This randomized controlled trial will be conducted in the Department of Dermatology and Venereology, Bangladesh Medical University, over 12 months from protocol acceptance. Patients aged 18-60 years with symmetric facial melasma fulfilling the eligibility criteria will be randomly allocated into two equal groups. Group A will receive triple-combination cream containing fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% on alternate nights for 12 weeks, along with monthly microneedling with TXA for three sessions. Group B will receive the same cream regimen along with monthly microneedling with PRP for three sessions. Efficacy will be assessed using the modified Melasma Area and Severity Index (mMASI) score. Patient satisfaction and adverse events will also be assessed during follow-up. Appropriate statistical methods will be used for comparison between the groups. Ethical approval will be obtained from the Institutional Review Board of Bangladesh Medical University.

Results Results will be assessed and presented after completion of the study. Conclusion Conclusion will be drawn after completion of the study. Keywords: Melasma, tranexamic acid, platelet-rich plasma, microneedling, triple-combination cream, mMASI.

Being tested
Group B (Triple Combination Cream + Microneedling + Platelet-Rich Plasma)
Keywords
Melasma, tranexamic acid, platelet-rich plasma, microneedling, triple-combination cream, mMASI
Medical subject headings
Melanosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group B (Triple Combination Cream + Microneedling + Platelet-Rich Plasma)Drug

    Group B (Triple Combination Cream + Microneedling + Platelet-Rich Plasma)

Study groups in NCT07893067
Study groupRoleWhat they receive
Group A ( Triple Combination Cream + Microneedling + Tranexamic Acid)ExperimentalNot described
Receives: Drug: Group B (Triple Combination Cream + Microneedling + Platelet-Rich Plasma)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Group A: Triple-combination cream + microneedling with tranexamic acid solution. Group B: Triple-combination cream + microneedling with platelet-rich plasma.

    Change in modified Melasma Area and Severity Index (mMASI) score from baseline to the end of the treatment.

    Assessment of treatment-related adverse effects.

    Measured: 30 days

Secondary outcomes (1)

  1. Group A: Triple-combination cream + microneedling with tranexamic acid solution. Group B: Triple-combination cream + microneedling with platelet-rich plasma.

    Patient satisfaction assessment using a 5-point Likert scale at the end of treatment.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2026
  2. Study start13 Oct 2026
  3. Primary completion12 Oct 2027 (estimated)
  4. Study completion13 Nov 2027 (estimated)

Resources

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07893067
Sponsor's protocol ID
6406
Status last verified
Oct 2026
First submitted
19 Oct 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Handel AC, Miot LDB, Miot HA. Melasma: a clinical and epidemiological review. An Bras Dermatol. 2014;89(5):771-782. doi:10.1590/abd1806- 4841.20143063. 2. Ogbechie-Godec OA, Elbuluk N. Melasma: an up-to-date comprehensive review. Dermatol Ther (Heidelb). 2017;7(3):305-318. doi:10.1007/s13555-017-0194-1. 3. Honigman A, Rodrigues M. Differential diagnosis of melasma and hyperpigmentation. Dermatol Rev. 2023;4(1):30-37. doi:10.1002/der2.144. 4. Ali L, Al Niaimi F. Pathogenesis of melasma explained. Int J Dermatol. 2025;64(7):1201-1212. doi:10.1111/ijd.17718. 5. Abdalla MA. Melasma clinical features, diagnosis, epidemiology and etiology: an update review. Siriraj Med J. 2021;73(12):841-850. doi:10.33192/SMJ.2021.109. 6. González-Molina V, Martí-Pineda A, González N. Topical treatments for melasma and their mechanism of action. J Clin Aesthet Dermatol. 2022;15(5):19-28. 7. Dhaliwal S, Dhanoa N, Rashid Z. Exploring the effectiveness, tolerability, and safety of the adjunctive use of microneedling with tranexamic acid in the treatment of melasma. J Cosmet Dermatol. 2026;25(3):e70763. doi:10.1111/jocd.70763. 8. Espósito ACC, Cassiano DP, da Silva CN, Lima PB, Dias JAF, Hassun K, et al. Update on melasma-Part I: pathogenesis. Dermatol Ther (Heidelb). 2022;12(9):1967-1988. doi:10.1007/s13555-022-00779 9. Tuknayat A, Bhalla M, Thami GP. Platelet-rich plasma is a promising therapy for melasma. J Cosmet Dermatol. 2021;20(8):2431-2436. doi:10.1111/jocd.14229.-x. 10. Aghdam SB, Mohammad AP, Hosseini-Baharanchi FS, Atefi N, Roohaninasab M, Kahjoogh HA, et al. Efficacy, safety, tolerability and treatment durability of microneedling plus topical tranexamic acid in combination with topical modified Kligman lightening formula for melasma: a four-arm assessor and analyst blinded randomized controlled clinical trial. J Cosmet Dermatol. 2024;23(11):3585-3597. doi:10.1111/jocd.16464. 11. Sonthalia S, Jha AK, Langar S. Dermoscopy of melasma. Indian Dermatol Online J. 2017;8(6):525-526. doi:

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Group B (Triple Combination Cream + Microneedling + Platelet-Rich Plasma) in people with Melasma (Facial Melasma), run by Bangladesh Medical University at 1 site in Bangladesh.

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 2 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: under way, not looking for participants, as of the sponsor's last update on 23 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 Bangladesh. 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?

Group A: Triple-combination cream + microneedling with tranexamic acid solution. Group B: Triple-combination cream + microneedling with platelet-rich plasma. (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07893067, which also lists 1 linked publication.

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 23 Oct 2026.

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