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New treatment option for Melasma
Official title Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy
ClinicalTrials.gov ID: NCT06516419
What this study is testing
What is Concentrated secretome Injection 2mL?
Concentrated secretome Injection 2mL is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melasma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 60, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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).
You likely can't join if
- 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...
- 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.
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jakarta Pusat, DKI Jakarta, Indonesia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 30 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jakarta Pusat, DKI Jakarta, Indonesia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.