Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy
Dr.dr.Irma Bernadette, SpKK (K)
90 participants
Feb 13, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Women diagnosed with melasma.
- Women without melasma and have areas of skin that are clinically free of lesions for SP control.
- years old.
- Fitzpatrick skin type IV-V.
- Willing to be a research subject by signing a research consent form (Informed Consent).
Exclusion Criteria12
- 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.
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Interventions
The secretome used in this research comes from mesenchymal stem cells from adipose tissue produced by IPT RSCM Stem Cell Medical Technology. The secretome produced by mesenchymal stem cells is collected, centrifuged to separate it from debris, and followed by filtration with a 0.22 μm pore filter to ensure sterility. Next, the concentration process is carried out using tangential flow filtration with the Spin-X UF 500® concentrator, packaged, and stored at -80 degrees Celsius. The product used is a sterile product, which is tested for sterility and total protein content. When it is to be used, the secretome is removed from the freezer, warmed (thawing), and injected into the patient according to a predetermined method.
1. Tranexamic acid 25 mg/ml is prepared by taking tranexamic acid in a vial 250 mg/5 ml as much as 0.5 ml (25 mg) using a 1 ml syringe and diluted with 0.5 ml 0.9% NaCl solution just before being injected into the SP. 2. Tranexamic acid 10 mg/ml is prepared by taking 0.2 ml (10 mg) of AT in a 250 mg/5 ml vial using a 1 ml syringe and diluting it with 0.8 ml of 0.9% NaCl solution for a moment. before injection into the Subject 2\. Tranexamic acid 10 mg/ml is prepared by taking 0.2 ml (10 mg) of AT in a 250 mg/5 ml vial using a 1 ml syringe and diluting it with 0.9% normal saline (NS) 0.8 ml just before injection into the Subject
1. Apply sunscreen SPF ≥30 in the morning on 2 knuckles 2. Apply triple combination cream (Refaquin) containing hydroquinone 40 mg, tretinoin 0.5 mg, and fluocinolone acetonide 0.1 mg at night all over the face except the area around the eyes, 1 fingertip unit (FTU) or 1 knuckle.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06516419