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

ConditionMelasma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-60
SponsorDr.dr.Irma Bernadette, SpKK (K)

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Concentrated secretome Injection 2mL
  • Tranexamic acid injection
  • Triple Combination Cream

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Dr.dr.Irma Bernadette, SpKK (K)

Lead sponsor

Indonesia University

Sponsor institution