Melasma Melasma Fractional Microablative Monopolar Radiofrequency
Conditions
Interventions
Device: The treatment is performed using the EXION device (BTL Aesthetic Ltd.), utilizing 1 MHz monopolar radiofrequency technology with the EXION Fractional RF applicator (Clear RF 64 tip, maximum en
s back, and the face is cleaned with 70 percent alcohol.
Procedure: A physician administers the RF treatment on the forehead, temples, cheeks, and chin. The energy level is adjusted based on the parti
s Fitzpatrick skin type (20 to 100 percent for Skin Type III and 20 to 70 percent for Skin Type IV) until mild erythema or edema appears.
Post-treatment Care: Cold compresses (ice bags) are applied fo
Experimental Procedure/Surgery
Fractional microablative monopolar radiofrequency
Sponsors
Private
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: -Be a healthy male or female of Thai nationality, aged 20 years and older. -Clinically diagnosed with epidermal type or mixed type melasma on the face. -Have a Fitzpatrick skin phototype of level III-V. -Participants must be willing to refrain from using skin-lightening products such as retinoids, alpha or beta hydroxy acids (AHA/BHA), salicylic acid, vitamin C, etc. on the face, and avoid undergoing chemical peels, laser treatments, or other energy-based medical device procedures throughout the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Infection or Inflammation Presence of acute or chronic infection or inflammation, whether systemic or local, including bacterial, viral, tuberculosis, and hepatitis infections, febrile illness, and active skin diseases in the treatment area (e.g., sores/ulcers, eczema/dermatitis, psoriasis, allergic rashes, or rosacea). 2. Immunodeficiency and Autoimmune Diseases Having an immunodeficiency, skin-related autoimmune diseases, and active connective tissue or collagen diseases. 3. Cancer and Pre-malignant Conditions Current or past history of any type of cancer, including skin cancer, and the presence of suspicious malignant or pre-malignant skin lesions. 4. Metallic or Electronic Implants Presence of any metallic or electronic implants, including pacemakers, internal defibrillators, electrical implants, or permanent implants near the treatment area or the neutral electrode application site. 5. Impaired Wound Healing or Fragile Skin Having conditions that result in poor wound healing, such as unhealed wounds, poorly controlled endocrine diseases (e.g., diabetes), history of keloids, very dry or fragile skin, or other skin diseases that affect wound healing. 6. Coagulation and Vascular Disorders History of bleeding or coagulation disorders, use of anticoagulants, and significant cardiovascular diseases, including thrombosis, phlebitis, and peripheral arterial disease. 7. History of Recent Medical or Aesthetic Treatments Use of oral isotretinoin within the past 12 months; received radiation therapy or chemotherapy; underwent surgery in the treatment area within the past 3 months or the wound is not completely healed; injection of fillers or other substances in the treatment area (e.g., botulinum toxin, collagen, fat) within the past 3 months; underwent laser or radiofrequency skin resurfacing in the treatment area within 3 months prior to starting the study; or use of topical or oral medications affecting skin pigmentation (causing darkening or lightening of the skin) within 14 days prior to joining the study. 8. Pregnancy and Breastfeeding Currently pregnant, breastfeeding, or undergoing in vitro fertilization (IVF) procedures. 9. Local Skin Contraindications Deeply tanned skin from sun exposure, sunbathing, or use of self-tanning creams within the past 2 weeks, or having tattoos/permanent makeup in the treatment area. 10. Hormone Use Patients taking oral contraceptives or hormone replacement therapy. 11. Use of Tranexamic Acid Patients continuously taking oral tranexamic acid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Melanin index Baseline,1month,2months,3months,5months,8months Mexameter | — |
Secondary
| Measure | Time frame |
|---|---|
| Melanin concentration Baseline,1month,2months,3months,5months,8months Antera 3D,Erythema level Baseline,1month,2months,3months,5months,8months Antera 3D,Sebum production Baseline,1month,2months,3months,5months,8months Sebumeter,Skin hydration Baseline,1month,2months,3months,5months,8months Corneometer,Transepidermal Water Loss Baseline,1month,2months,3months,5months,8months Tewameter,Skin surface pH Baseline,1month,2months,3months,5months,8months Skin pH-meter,facial skin microbiome sample collection Baseline,1month 16S rRNA gene sequencing,mMASI Baseline,1month,2months,3months,5months,8months clinical scoring,Global Aesthetic Improvement Scale 1month,2months,3months,5months,8months Patient-reported outcomes compared to baseline,Pain Score Baseline,1month,2months Numeric Rating Scale | — |
Countries
Thailand
Contacts
Public ContactJitlada Meephansan
Thammasat University
Outcome results
None listed