Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy
NCT Number: NCT06516419
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Melasma
Interventions: DRUG: Concentrated secretome Injection 2mL|DRUG: Tranexamic acid injection|DRUG: Triple Combination Cream
Sponsor: Dr.dr.Irma Bernadette, SpKK (K)
Sex: FEMALE
Age: ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-02-13
Completion Date: 2025-03-30
Locations: Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia, Jakarta Pusat, DKI Jakarta, 10430, Indonesia|Dr. Cipto Mangunkusumo Hospital, Jakarta Pusat, DKI Jakarta, 10430, Indonesia

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

Primary Outcome Measures: Change of Melasma Severity based on modified Melasma Severity Index (mMASI) score., The range of values for mMASI is between 0 and 24 which can then be divided into mild melasma (0-8), moderate (8-16), and severe (16-24).

improvement occurs if the mMASI score decreases by \<50% from the previous visit worsening if score persists or mMASI Score Increase \>50%, re-evaluation on day 14, 28, 42, 56 and day 84 of therapy|Change of Melasma Severity based on Patient's Tolerability Assesment (PtGA)., one method of evaluating the response to therapy in melasma which is assessed subjectively by the patient. The response to therapy can be assessed as follows

No or slight response: \< 25% improvement Moderate response: 25% - 50% improvement Good response: 50% improvement - \< 75% Excellent response: improvement \> 75% The response is said to be good if the score is above 50% since the previous visit, re-evaluation on day 14, 28, 42, 56 and day 84 of therapy|Change of Melasma Severity based on Dermoscopy, based on Dermoscopy

Telangiectasis score assessment using a 5-point dermoscopy-scale:

0 = No visible capillaries.

1 = Elongated capillaries accompanied by dilation, not visible to the naked eye. 2 = Moderate telangiectasis that is beginning to be visible to the naked eye.

3 = Severe telangiectasis characterized by reduced capillary loops. 4 = Very severe telangiectasis characterized by dilatation and loss of capillary loops., re-evaluation on day 84 of therapy|Change of Melasma Severity based on Wood's Lamp, Epidermal Type/ Dermal Typed/ Mixed Typed, re-evaluation on day 84 of therapy|Compare Quality Of Life based on MelasQoL Score, based on MelasQoL Score minimum score: 7 maximum score : 70, re-evaluation on day 84 of therapy|Change of Melanin Index Based on Mexameter, improves if there is a decrease in melanin levels \> 50% from the initial visit It is said to be bad or persistent if there is no decrease in melanin levels or there is a decrease of \<50%, re-evaluation on day 14, 28, 42, 56 and day 84 of therapy|Change of Erytema Index Based on Mexameter, improves if there is a decrease in Erytema levels \> 50% from the initial visit It is said to be bad or persistent if there is no decrease in erythema levels or there is a decrease of \<50%, re-evaluation on day 14, 28, 42, 56 and day 84 of therapy