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

Launched by DR.DR.IRMA BERNADETTE, SPKK (K) · Jul 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying new treatment options for melasma, a common skin condition that causes dark patches on the face. Researchers want to find out how effective and safe three different treatments are: an injection using concentrated secretome (a substance released by stem cells), a special cream made from a combination of ingredients, and an injection of tranexamic acid. The study will include 90 women aged 30 to 60 who have been diagnosed with melasma or have clear skin to serve as a comparison.

To participate, women must be willing to sign a consent form and meet certain criteria, such as not being pregnant or breastfeeding and not having used specific skin treatments recently. Participants will receive one of the treatments and will be monitored for safety and effectiveness. Additionally, the study will assess how these treatments affect the quality of life for women living with melasma. If you’re interested in participating or learning more, it’s important to discuss this with your healthcare provider.

Gender

FEMALE

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.