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

NCT07194200 | Recruiting Phase 2

• 1 other identifier: LL-KY-2025150-02
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lactobacillus Plantarum; Psoriasis

Keywords

psoriasis; Lactobacillus plantarum

Outcome Measures

Primary Outcomes (5)

• Transepidermal Water Loss(TEWL)

  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.

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

• General appearance photography

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

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

• Dermoscopic photography

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

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

• Completion of self-assessment questionnaires

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

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

• Adverse reactions

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

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

Study Arms (2)

group A

EXPERIMENTAL

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.

Biological: Lactobacillus plantarum

group B

ACTIVE COMPARATOR

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

Biological: inactivated Lactobacillus plantarum

Interventions

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.

group A

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.

group B

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jianglin Zhang

CONTACT

+86 13873143466; zhang.jianglin@szgospital.com

zhen lin

CONTACT

+86 13588142362

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)