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NCT Number: NCT07194200

Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial

A growing body of evidence indicates that the pathogenesis of psoriasis may be closely linked to skin microbiome dysbiosis. Compared with healthy individuals, the composition and function of the skin microbiota in psoriasis patients exhibit significant alterations5,6. This microbial imbalance is thought to contribute to the initiation and progression of the disease through mechanisms such as triggering abnormal immune responses, exacerbating inflammatory processes, and impairing the skin barrier.

In-depth exploration of the interplay between psoriasis and the microbiome not only offers new perspectives for elucidating the disease's pathogenesis but also lays the groundwork for developing innovative microbiota-targeted diagnostic and therapeutic strategies. Thus, identifying novel therapeutic approaches that bridge psoriasis treatment and microbial regulation holds substantial clinical and social value.

While existing treatments for psoriasis have made some progress, research specifically focusing on the microbiota-psoriasis relationship remains relatively limited. Investigating the intrinsic connections between microecological balance and psoriasis management, and developing practical improvement strategies, is therefore of crucial practical significance for enhancing skin health and improving quality of life. This study aims to address this research gap and provide a new therapeutic option for individuals with psoriasis.

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Key information

Conditions

Psoriasis Lactobacillus Plantarum Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location status: Recruiting

Location contact

Shenzhen People's Hospital

CONTACT

[email protected]

+86 75522943881

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Reference to Psoriasis Area and Severity Index (PASI) score < 10 Patients have been informed of the study details, voluntarily participate, and have signed the informed consent form; Aged 18-60 years with good general health status; No use of any medications within 6 months; No various inflammatory or immune skin diseases, no local infections, and no neuromuscular diseases.

Exclusion criteria

  • Patients with other types of psoriasis or severe psoriasis; Those in the active phase of skin diseases or with other serious diseases; Other situations deemed unsuitable for enrollment by the researchers, such as subjects who are untrustworthy, unable to accept or understand the study assessments.

Treatment and study plan

Lactobacillus plantarum

Biological

Intervention measures for the experimental group: Apply 5ml of Lactobacillus plantarum solution extracted from the skin surface of healthy individuals to the psoriatic lesions daily, for a duration of 2 months.

inactivated Lactobacillus plantarum

Biological

Intervention measures for the control group: Apply 5ml of inactivated Lactobacillus plantarum solution to the psoriatic lesions daily, for a duration of 2 months.

Primary outcomes

  1. Transepidermal Water Loss(TEWL)

    Time frame: The follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.

    Use a dermatological detector to measure the TEWL of the skin. Gently press the probe against the subject's skin, and the TEWL at that location will be displayed on the device's screen.

  2. General appearance photography

    Time frame: The follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.

    After shooting, three professional doctors will independently assess the improvement of psoriatic lesions in patients.

  3. Dermoscopic photography

    Time frame: The follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.

    After shooting, three professional doctors will independently assess the improvement of psoriatic lesions in patients.

  4. Completion of self-assessment questionnaires

    Time frame: The follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.

    Record the improvement of patients' self-perceived suboptimal skin conditions after treatment compared with the baseline.

  5. Adverse reactions

    Time frame: The follow-up periods are set at 1, 2, 4, and 8 weeks after the initial treatment.

    Subjects will record predefined expected post-treatment events at the treated sites.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianglin Zhang

CONTACT

[email protected]

+86 13873143466

zhen lin

CONTACT

+86 13588142362

Sponsors and collaborators

Lead sponsor

Shenzhen People's Hospital

Other

Registry information

Official study title

Evaluating the Safety and Efficacy of Lactobacillus Plantarum in Treating Psoriasis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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