Status:
NOT_YET_RECRUITING
Secretome TGF Beta 3
Lead Sponsor:
Indonesia University
Conditions:
Melasma
Eligibility:
FEMALE
30-60 years
Phase:
NA
Brief Summary
A therapeutic modality currently being developed for melasma is secretome. Secretome is a bioactive molecule secreted by mesenchymal stem cells in a conditioned medium containing a large number of gro...
Detailed Description
Melasma is a pigmentation disorder in the form of brownish macules with irregular edges caused by dysfunctional melanogenesis. Melasma is more common in women with Fitzpatrick skin types IV-VI, namely...
Eligibility Criteria
Inclusion
- Women diagnosed with melasma.
- Women without melasma and have areas of skin that are clinically free of lesions for SP control.
- 30-60 years old.
- Fitzpatrick skin type IV-V.
- Willing to be a research subject by signing a research consent form (Informed Consent).
Exclusion
- Pregnant and breastfeeding women.
- Currently using hormonal contraception or have ever used contraception hormones in the last 6 months.
- Using topical therapy for melasma, for example corticosteroids, tretinoin, hydroquinone, and other therapies that whiten or brighten the skin in the last 2 weeks.
- Using topical triple combination cream therapy for at least 3 months and did not show significant improvement
- Using systemic therapy for melasma, for example antioxidants or tranexamic acid in the last 4 weeks.
- History of superficial peeling therapy in the last 4 weeks.
- History of deep peeling therapy, laser or mechanical abrasion in the last 6 months.
- Using drugs that are photosensitizers such as tetracycline, phenytoin, carbamazepine, spironolactone.
- History of blood clotting disorders or on blood thinning therapy.
- Allergy to tranexamic acid.
- Have other skin complaints that may interfere with the evaluation of melasma, for example post-inflammatory hyperpigmentation, Hori's nevus, Ota's nevus, pigmented contact dermatitis, and other pigmentation disorders
- Difficulty complying with treatment.
Key Trial Info
Start Date :
February 14 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT07137130
Start Date
February 14 2026
End Date
December 20 2026
Last Update
August 22 2025
Active Locations (1)
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1
Dr. Cipto Mangunkusumo Hospital
Central Jakarta, D.k.i Jakarta, Indonesia, 10430