Topical probiotic Lactobacillus lactis treatment in atopic dermatitis: a placebo-controlled pilot study on tolerability and efficacy.
- 2026-02-03
- Frontiers in medicine 13
- Ville Salo
- Anita Remitz
- Antti Lauerma
- Alexander Salava
- PubMed: 41709889
- DOI: 10.3389/fmed.2026.1694229
Study Design
- Type
- Clinical Trial
- Sample size
- n = 13
- Population
- 13 patients with mild-to-moderate AD
- Methods
- treated with differently concentrated probiotic creams (3, 10, and 30%) for 4 weeks
- Duration
- 4 weeks
Introduction
Microbiome-targeted treatments have been investigated in atopic dermatitis (AD). We aimed to investigate the tolerability and efficacy of probiotic Lactobacillus lactis lysate cream in AD.Methods
A total of 13 patients with mild-to-moderate AD were treated with differently concentrated probiotic creams (3, 10, and 30%) for 4 weeks. The severity of AD [Eczema Area and Severity Index (EASI) and Investigator Global Assessment (IGA)], epidermal barrier function (TEWL), and the impact of AD [Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), Atopic Dermatitis Control Tool (ADCT), and pruritus and sleep disturbance visual analog scale (VAS)] were measured at baseline (BL) and at 4 and 8 weeks. Comprehensive clinical patient data and laboratory values, including blood eosinophil count, total serum IgE levels, and specific IgEs to aeroallergens, were obtained.Results
Comparison of the treatment groups and longitudinal comparisons at various time points showed no significant differences regarding AD severity (EASI, p = 0.76, CI: 0.65-1.00), epidermal barrier dysfunction (TEWL, p = 0.37, CI: 0.19-0.73), or patient-reported subjective impact of AD (DLQI, p = 0.76, CI: 0.65-1.00; POEM, p = 0.76, CI: 0.35-0.88; ADCT, p = 0.72, CI: 0.65-1.00; pruritus VAS 0.67, CI: 0.55-1.00; sleep disturbance VAS, p = 1.00, CI: 0.79-1.00) between different probiotic lysate concentrations and placebo. The probiotic lysate cream was well-tolerated, and there were no significant adverse effects. The limitations of the study were the small patient cohort and group sizes. There was also a relatively short follow-up, and no evaluation of long-term effects was conducted.Discussion
In our patient cohort, topical probiotic L. lactis lysate cream showed good tolerability, but it did not show efficacy in the treatment of mild-to-moderate AD. Although topical probiotics have been reported to be effective in a limited number of studies, more placebo-controlled clinical studies are needed to explore their potential role in the treatment of AD.Clinical trial registration
https://eudract.ema.europa.eu, Identifier EudraCT 2020-000514-15.Research Insights
ADCT, p = 0.72, CI: 0.65-1.00
- Effect
- Neutral
- Effect size
- Small
- Dose
- 3%, 10%, and 30% cream (probiotic lysate cream)
patient-reported subjective impact of AD (DLQI, p = 0.76, CI: 0.65-1.00)
- Effect
- Neutral
- Effect size
- Small
- Dose
- 3%, 10%, and 30% cream (probiotic lysate cream)
POEM, p = 0.76, CI: 0.35-0.88
- Effect
- Neutral
- Effect size
- Small
- Dose
- 3%, 10%, and 30% cream (probiotic lysate cream)
Comparison of the treatment groups and longitudinal comparisons at various time points showed no significant differences regarding AD severity (EASI, p = 0.76, CI: 0.65-1.00)
- Effect
- Neutral
- Effect size
- Small
- Dose
- 3%, 10%, and 30% cream (probiotic lysate cream)
Comparison of the treatment groups and longitudinal comparisons at various time points showed no significant differences regarding AD severity (EASI, p = 0.76, CI: 0.65-1.00; IGA not separately reported with p-value but included as a severity measure; no significant differences mentioned)
- Effect
- Neutral
- Effect size
- Small
- Dose
- 3%, 10%, and 30% cream (probiotic lysate cream)
pruritus VAS 0.67, CI: 0.55-1.00
- Effect
- Neutral
- Effect size
- Small
- Dose
- 3%, 10%, and 30% cream (probiotic lysate cream)
sleep disturbance VAS, p = 1.00, CI: 0.79-1.00
- Effect
- Neutral
- Effect size
- Small
- Dose
- 3%, 10%, and 30% cream (probiotic lysate cream)
epidermal barrier dysfunction (TEWL, p = 0.37, CI: 0.19-0.73)
- Effect
- Neutral
- Effect size
- Small
- Dose
- 3%, 10%, and 30% cream (probiotic lysate cream)
Adverse Events Reported
The probiotic lysate cream was well-tolerated, and there were no significant adverse effects.
- Finding
- Reported