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Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy
Sponsor: Dr.dr.Irma Bernadette, SpKK (K)
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
Key Details
Gender
FEMALE
Age Range
30 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-02-13
Completion Date
2025-03-30
Last Updated
2024-07-24
Healthy Volunteers
Yes
Conditions
Interventions
Concentrated secretome Injection 2mL
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.
Tranexamic acid injection
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
Triple Combination Cream
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)
Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia
Dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia