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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 60
Healthy Volunteers: t
View:

• Women diagnosed with melasma.

• Women without melasma and have areas of skin that are clinically free of lesions for SP control.

• 30-60 years old.

• Fitzpatrick skin type IV-V.

• Willing to be a research subject by signing a research consent form (Informed Consent).

Locations
Other Locations
Indonesia
Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia
RECRUITING
Jakarta Pusat
Dr. Cipto Mangunkusumo Hospital
RECRUITING
Jakarta Pusat
Contact Information
Primary
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang
irma_bernadette@yahoo.com
+62818130761
Backup
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang Sitohang
irma_bernadette@yahoo.com
+62818130761
Time Frame
Start Date: 2024-02-13
Estimated Completion Date: 2025-03-30
Participants
Target number of participants: 90
Treatments
Experimental: Group A (Secretom group)
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.
Experimental: Group B (Triple Combination Group)
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.
Experimental: Group C (Tranexamic Acid Group)
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.
Related Therapeutic Areas
Infertility
Melasma
Sponsors
Leads: Dr.dr.Irma Bernadette, SpKK (K)

This content was sourced from clinicaltrials.gov

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