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

NCT07893067 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 6406
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Melasma (Facial Melasma)

Keywords

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

Outcome Measures

Primary Outcomes (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.

  30 days

Secondary Outcomes (1)

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

  30 days

Study Arms (1)

Group A ( Triple Combination Cream + Microneedling + Tranexamic Acid)

EXPERIMENTAL

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

Interventions

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

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

Group A ( Triple Combination Cream + Microneedling + Tranexamic Acid)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Department of Dermatology and venereology, BMU

Dhaka, 1230, Bangladesh

Location

Related Publications (1)

• 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:

  BACKGROUND

MeSH Terms

Conditions

Melanosis

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS Trainee

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start: October 13, 2026
• Primary Completion (Estimated): October 12, 2027
• Study Completion (Estimated): November 13, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)