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Clinical Trials/NCT07194200
NCT07194200RecruitingPhase 2

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

Shenzhen People's Hospital1 site in 1 country184 target enrollmentStarted: December 15, 2025Last updated:
Interventions

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
184
Locations
1
Primary Endpoint
Transepidermal Water Loss(TEWL)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
16 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: Lactobacillus plantarum (Biological)

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.

Intervention: inactivated Lactobacillus plantarum (Biological)

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Shenzhen People's Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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