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

NCT06516419 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-07-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Dr.dr.Irma Bernadette, SpKK (K)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-13
Primary Completion
2025-03-30
Completion
2025-03-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06516419 on ClinicalTrials.gov