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

NARecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

February 13, 2024

Primary Completion Date

March 30, 2025

Study Completion Date

March 30, 2025

Conditions
Melasma
Interventions
DRUG

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.

DRUG

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"

DRUG

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."

Trial Locations (2)

10430

RECRUITING

Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia, Jakarta Pusat

RECRUITING

Dr. Cipto Mangunkusumo Hospital, Jakarta Pusat

All Listed Sponsors
lead

Dr.dr.Irma Bernadette, SpKK (K)

OTHER