Active, not recruitingNCT07893067Updated Oct 23, 2026

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 interventional study of Group B (Triple Combination Cream + Microneedling + Platelet-Rich Plasma) in Melasma (Facial Melasma), sponsored by Bangladesh Medical University. Active, not recruiting at 1 site in Bangladesh. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Bangladesh Medical University · Phase 4, Interventional, and Treatment

Updated Oct 23, 2026Newly registeredGo to Updates ↓

Phase: Phase 4
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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. 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.

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.

Conditions studied

Melasma (Facial Melasma)

Browse trials for

Melanosis 159

Keywords

Melasma, tranexamic acid, platelet-rich plasma, microneedling, triple-combination cream, mMASI

In context

Melanosis

159 studies on the registry are indexed under Melanosis; 42 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 149 interventional studies indexed under Melanosis.

Browse Melanosis studies →

Lead sponsor

Bangladesh Medical University is the lead sponsor of 41 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

- 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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 60 participants (estimated)

Study arms

Experimental
Group A ( Triple Combination Cream + Microneedling + Tranexamic Acid)
Drug: Group B (Triple Combination Cream + Microneedling + Platelet-Rich Plasma)

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: 30 days

Secondary outcomes

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.
Time frame: 30 days

Study locations

1 site

Department of Dermatology and venereology, BMU
Dhaka, 1230, Bangladesh

References and documents

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:

Individual participant data

Plan to share: No

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for Oct 2027, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 19, 2026
First posted: Oct 23, 2026
StartActual: Oct 13, 2026
Primary completionEst.: Oct 12, 2027
CompletionEst.: Nov 13, 2027
Last update: Oct 23, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 23, 2026

Show all 1 update

Oct 23, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07893067
Lead sponsor: Bangladesh Medical University
Responsible party: Khadija Afrin (FCPS Trainee, Bangladesh Medical University) — Principal investigator
First posted: Oct 23, 2026
Start date: Oct 13, 2026
Primary completion: Oct 12, 2027 (estimated)
Completion: Nov 13, 2027 (estimated)
Last update: Oct 23, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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