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The effects of topical probiotics in in improving mild to moderate plaque psoriasis disease

Investigating the effects of Topical cream containing probiotic and postbiotic complex in improving the symptoms of patients with mild to moderate plaque psoriasis: a randomized, double blind, placebo-controlled clinical trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220429054695N3
Enrollment
40
Registered
2024-10-29
Start date
2024-09-22
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Mild to moderate plaque psoriasis. Psoriasis vulgaris

Interventions

Intervention 1: Intervention group: The intervention group under study includes twenty patients of both genders aged between 12 to 75 years who have mild to moderate plaque psoriasis. The percentage o

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 75 Years

Inclusion criteria

Inclusion criteria: BSA (Body surface area) score < 5% Total PASI score < 10 DQLI (dermatology quality of life index) score < 10 VAS (visual analogue scaling) score < 8 Age over 12 years for both genders Patient's consent to participate in the study. Discontinuation of topical treatments two weeks prior to the start of the study, or stability of lesion severity with previous treatments. For patients receiving systemic treatment, discontinuation of treatment at least one month before the start of the study, or stability of lesions with systemic treatment for at least one month prior.

Exclusion criteria

Exclusion criteria: Pregnancy and breastfeeding -Allergy or sensitivity to the components in the formulation Diagnosis of other autoimmune diseases Diagnosis of any malignancy, such as lymphoma Diagnosis of any infectious disease Worsening of lesions and a significant increase in the scores of the studied indices

Design outcomes

Primary

MeasureTime frame
Changes in the percentage of body surface area affected by psoriasis using the BSA tool. Timepoint: Every two weeks for up to 6 weeks and compare it to the initial score. Method of measurement: Scoring of BSA (Body Surface Area) in mild to moderate psoriasis, with assessments conducted every two weeks in both the intervention and placebo groups, and comparison of their changes with each other.;Changes in the area and severity index using the PASI score. Timepoint: Every two weeks for up to 6 weeks and compare it to the initial score. Method of measurement: Scoring of the Psoriasis Area and Severity Index (PASI) every two weeks in both the intervention and placebo groups, and comparison of their changes with each other.;Determining the score of the Dermatology Life Quality Index (DLQI) questionnaire. Timepoint: Every two weeks for up to 6 weeks and compare it to the initial score. Method of measurement: Scoring of the Dermatology Life Quality Index (DLQI) questionnaire before and after the treatment in both the intervention and placebo groups, and comparison of their changes with each other.;Assessing the severity of itching, burning, and pain of lesions using the Visual Analog Scale (VAS). Timepoint: Every two weeks for up to 6 weeks and compare it to the initial score. Method of measurement: Scoring the intensity of itching, burning, and pain of lesions using the Visual Analogue Scale (VAS) every two weeks in both the intervention and placebo groups, and comparison of their changes with each other.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParnazPahlevan

Islamic Azad University

parnazpahlevan@gmail.com+98 21 2264 0056

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026