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A split-face clinical trial evaluating the efficacy and safety of topical probiotic culture supernatant versus placebo in the treatment of melasma.

A split-face clinical trial evaluating the efficacy and safety of topical probiotic culture supernatant versus placebo in the treatment of melasma.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260325003
Enrollment
30
Registered
2026-03-25
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma including epidermal, dermal, and mixed types. Melasma Probiotics Chloasma Lactobacillus Bifidobacterium Skin pigmentation Skin erythema Skin texture Skin uniformity Wrinkles Photoaging

Interventions

Topical probiotic culture filtrate lotion applied to the randomized side of the face affected by melasma. Participants will apply approximately 1 fingertip unit (about 0.2 to 0.4 g) as a thin layer ov
Experimental Drug,Placebo Comparator Drug
A lotion containing probiotics culture supernatant from Lactobacillus paracasei MSMC39-1 and Bifidobacterium animalis TA-1 ,Placebo

Sponsors

Professor Montree Udompataikul, MD
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older, of any sex. 2. Clinically diagnosed bilateral facial melasma with approximately symmetrical involvement on both sides of the face, confirmed by a dermatologist. 3. No chronic medical conditions that may interfere with study participation or affect study outcomes. 4. Willing and able to comply with study procedures and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation. 2. Use of medications or treatments that may affect melasma within the preceding 12 weeks (washout period), including: topical or oral corticosteroids, skin-lightening agents (e.g., hydroquinone, arbutin, azelaic acid, kojic acid, tranexamic acid, resorcinol, vitamin C), agents that inhibit melanin transfer (e.g., soy, niacinamide), exfoliative agents (e.g., retinoids, AHA, BHA), agents that alter melanin synthesis (e.g., glutathione), antioxidants (e.g., vitamin C, vitamin E), cosmetic or dermatologic procedures such as chemical peeling, dermabrasion, mesotherapy, or laser treatment. 3. Presence of facial skin diseases that may interfere with assessment of the study area, including eczema, psoriasis, rosacea, severe or cystic acne, facial infection, inflammation, or contact dermatitis. 4. History of photosensitivity disorders, including autoimmune diseases, connective tissue disorders, or photodermatoses.

Design outcomes

Primary

MeasureTime frame
Skin pigmentation Weeks 0 (baseline), 4, 8, 12 after treatment modified MASI score

Secondary

MeasureTime frame
Skin parameter improvements including skin pigmentation, skin uniformity/texture, pore sizes, and wrinkles. Weeks 0 (baseline), 4, 8, 12 after treatment ANTERA 3D,Physician and patient global assessment scores Weeks 4, 8, 12 after treatment Physician and patient reported outcomes,Safety assessment Weeks 4, 8, 12 after treatment Recording of symptoms, date of event, date of report, grading, and description of event.

Countries

Thailand

Contacts

Public ContactMontree Udompataikul

Department of Dermatology, Faculty of Medicine, Srinakharinwirot University

umontree@gmail.com022594260

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026