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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research is a clinical study designed as a single-blind randomized controlled trial to evaluate treatments for melasma, a pigmentation disorder causing brownish patches on the skin. The study aims to assess the effectiveness and safety of intradermal concentrated secretome injection, triple combination cream, and intradermal tranexamic acid injection in melasma patients. It also seeks to understand the quality of life of patients after triple combination cream therapy and to measure superoxide dismutase (SOD) levels. Participants are divided into three groups of 30 each: one receiving secretome injections, another using triple combination cream, and the third receiving tranexamic acid injections. The secretome and tranexamic acid groups also use 0.5% tretinoin cream for two weeks before treatment. The secretome group receives injections three times over 8 weeks, with evaluations every 4 weeks. The triple combination cream group applies the cream nightly with evaluations every 4 weeks. The tranexamic acid group receives injections every 2 weeks with evaluations at multiple timepoints. During the 12-week study, participants undergo physical exams, clinical photos, mMASI scoring, dermoscopy, Wood's lamp examination, mexameter measurements, and patient tolerability assessments at scheduled intervals. Data on melasma severity, melanin and erythema indices, and quality of life are collected and analyzed. The study includes monitoring for safety and treatment adherence, with all participants receiving facial wash and sunscreen as part of their regimen.
CONDITIONS
Brief 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 skin areas free of lesions for control
- Aged 30 to 60 years
- Fitzpatrick skin type IV or V
- Willing to participate and sign informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Current or recent (last 6 months) use of hormonal contraception
- Use of topical melasma therapies like corticosteroids, tretinoin, hydroquinone within last 2 weeks
- Use of triple combination cream for at least 3 months without improvement
- Use of systemic melasma therapies in last 4 weeks
- History of superficial peeling in last 4 weeks
- History of deep peeling, laser, or mechanical abrasion in last 6 months
- Use of photosensitizing drugs such as tetracycline, phenytoin, carbamazepine, spironolactone
- History of blood clotting disorders or blood thinning therapy
- Allergy to tranexamic acid
- Other skin conditions interfering with melasma evaluation
- Difficulty complying with treatment requirements
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants in the Secretome injection and Tranexamic acid injection groups apply 0.5% Tretinoin cream for 2 weeks as preparation before treatment begins.
1 visit (in-person) for initial assessment before preparation
Duration - 12 weeks
Participants receive their assigned treatments: intradermal concentrated secretome injections, triple combination cream, or intradermal tranexamic acid injections, alongside use of facial wash and sunscreen. Secretome and tranexamic acid injection groups continue using 0.5% tretinoin cream at night while the triple combination group uses Refaquin cream at night.
Group A: 4 visits at weeks 0, 4, 8, and 12 with 3 secretome injections at weeks 0, 4, and 8; Group B: 4 visits at weeks 0, 4, 8, and 12; Group C: 6 visits at weeks 0, 2, 4, 6, 8, and 12
Duration - Concurrent with treatment visits over 12 weeks
At each evaluation visit, participants undergo physical examination, mMASI scoring, Patient's Tolerability Assessment (PtGA), and mexameter examination to monitor changes in melasma severity and skin condition.
Aligned with treatment visits as per each group schedule
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
P
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang Sitohang
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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