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

NCT06516419 | Recruiting

• 1 other identifier: Secretome
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

Group A (Secretom group)

EXPERIMENTAL

Group A, the treatment group, used Secretom 2ml Intradermal injection, Sunscreen in the morning and used Tretinoin cream 0,05% at night and cleanser which was used in the morning and evening before using the cream.

Drug: Concentrated secretome Injection 2mL

Group B (Triple Combination Group)

EXPERIMENTAL

Group B, the treatment group, getting sunscreen cream in the morning and triple combination (Refaquin) cream at night and facial soap that can be used in the morning and evening.

Drug: Triple Combination Cream

Group C (Tranexamic Acid Group)

EXPERIMENTAL

Group C, the treatment group, used Intradermal Injection of Tranexamic Acid 10mg/mL and 25mg/mL split face , Sunscreen in the morning and used Tretinoin cream 0,05% at night and cleanser which was used in the morning and evening before using the cream.

Drug: Tranexamic acid injection

Interventions

Concentrated secretome Injection 2mL DRUG

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.

Group A (Secretom group)

Tranexamic acid injection DRUG

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

Group C (Tranexamic Acid Group)

Triple Combination Cream DRUG

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.

Group B (Triple Combination Group)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr.dr.Irma Bernadette, SpKK (K): lead

Study Sites (2)

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

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

Dr. Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Melanosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang

CONTACT

+62818130761; irma_bernadette@yahoo.com

Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang Sitohang

CONTACT

+62818130761; irma_bernadette@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K)

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 24, 2024
• Study Start: February 13, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

ID (2)