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Recruiting NCT06516419

Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy

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Trial Parameters

Condition Melasma
Sponsor Dr.dr.Irma Bernadette, SpKK (K)
Study Type INTERVENTIONAL
Phase N/A
Enrollment 90
Sex FEMALE
Min Age 30 Years
Max Age 60 Years
Start Date 2024-02-13
Completion 2025-03-30
Interventions
Concentrated secretome Injection 2mLTranexamic acid injectionTriple Combination Cream

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Brief Summary

This research is a clinical study with a single-blind randomized clinical trial design (randomized controlled trial) in RSCM-FKUI This study aims to Assess the effectiveness and safety of intradermal concentrated secretome injection therapy, triple combination cream, and intradermal tranexamic acid injection in melasma patients, determine the quality of life profile of melasma patients after triple combination cream therapy in melasma therapy, and determine SOD levels in melasma patients. This research will be attended by 90 research subjects

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

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