Actively Recruiting
Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy
Led by Dr.dr.Irma Bernadette, SpKK (K) · Updated on 2024-07-24
90
Participants Needed
2
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women diagnosed with melasma
- Women without melasma with clinically clear skin areas for control
- Aged 30 to 60 years
- Fitzpatrick skin type IV or V
- Willing to participate and able to sign informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Using or have used hormonal contraception within the last 6 months
- Using topical melasma treatments like corticosteroids, tretinoin, hydroquinone, or other whitening treatments within 2 weeks
- Using triple combination cream therapy for at least 3 months without significant improvement
- Using systemic melasma treatments such as antioxidants or tranexamic acid within 4 weeks
- History of superficial peeling therapy within 4 weeks
- History of deep peeling, laser, or mechanical abrasion within 6 months
- Using photosensitizing drugs like tetracycline, phenytoin, carbamazepine, or spironolactone
- History of blood clotting disorders or current blood thinning therapy
- Allergy to tranexamic acid
- Other skin conditions that affect melasma evaluation (e.g., post-inflammatory hyperpigmentation, Hori's nevus, Ota's nevus, pigmented contact dermatitis)
- Difficulty complying with treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Actively Recruiting
2
Dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Actively Recruiting
Research Team
P
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang
CONTACT
P
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang Sitohang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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