New treatments for melasma using stem cell secretome and other therapies

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

This study is testing three different treatments for melasma to see which one works best and improves the quality of life for people dealing with this skin condition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 30 Years to 60 Years
• Sex: Female
• Sponsor: Indonesia University (Academic / other)
• Locations: 2 sites (Jakarta Pusat, DKI Jakarta and 1 other locations)
• Trial ID: NCT06516419 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of three different treatments for melasma: intradermal concentrated secretome injections, a triple combination cream, and intradermal tranexamic acid injections. The study involves 90 participants and employs a single-blind randomized controlled trial design. It aims to assess not only the therapeutic outcomes but also the quality of life of patients using the MELASQoL-INA questionnaire. The secretome used in the study is derived from mesenchymal stem cells and contains various bioactive molecules that may enhance skin regeneration.

Who should consider this trial

Good fit: Ideal candidates are women aged 30-60 with Fitzpatrick skin types IV-V diagnosed with melasma.

Not a fit: Patients who are pregnant, breastfeeding, or have used certain hormonal or topical therapies recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new, effective treatment options for patients suffering from melasma.

How similar studies have performed: While this approach is novel in Indonesia, similar studies in other regions have shown promising results with stem cell-derived therapies for skin conditions.

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 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.

Where this trial is running

Jakarta Pusat, DKI Jakarta and 1 other locations

• Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia — Jakarta Pusat, DKI Jakarta, Indonesia (Recruiting)
• Dr. Cipto Mangunkusumo Hospital — Jakarta Pusat, DKI Jakarta, Indonesia (Recruiting)

Study contacts

• Study coordinator: Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang

Conditions Melasma