Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy
Recruiting
N/AInterventional Study
Melasma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
30 – 60
Sex
Female
Study type
Interventional
Purpose
Other
Participants needed
90 (estimated)
Sponsor
Dr.dr.Irma Bernadette, SpKK (K) · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 trip…
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
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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).
Exclusio…
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Contacts
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang
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