NCT06301997

Brief Summary

The goal of this interventional clinical trial study is to compare ZAX.1400.P03 and placebo in Psoriasis patients. The main question it aims to answer is: • Can treatment with ZAX.1400.P03 for 3 weeks improve clinical signs of skin in psoriasis patients? Participants will be divided into two groups of 52 people. One group will use ZAX.1400.P03 topically twice daily for 3 weeks and the other group will use placebo topically twice daily for 3 weeks. Researchers will compare treatment and placebo groups to see if there is any improvement in the clinical signs of skin caused by psoriasis after treatment with ZAX.1400.P03 for 3 weeks.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

2.4 years

First QC Date

March 4, 2024

Last Update Submit

March 10, 2025

Conditions

PsoriasisInflammationSkin Diseases

Keywords

Skin DiseasesPsoriasisHerbal MedicinesAnti-inflammatoryNatural ProductsInflammation

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Dermatology Life Quality Index (DLQI) score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    DLQI score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    Baseline and Weeks 1, 2, 3, 4, 5, and 6

Secondary Outcomes (12)

  • Change From Baseline in Percent Body Surface Area (%BSA) at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    Baseline and Weeks 1, 2, 3, 4, 5, and 6

  • Change From Baseline in erythema score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    Baseline and Weeks 1, 2, 3, 4, 5, and 6

  • Change From Baseline in Swelling score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    Baseline and Weeks 1, 2, 3, 4, 5, and 6

  • Change From Baseline in pruritus score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    Baseline and Weeks 1, 2, 3, 4, 5, and 6

  • Change From Baseline in flake score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    Baseline and Weeks 1, 2, 3, 4, 5, and 6

  • +7 more secondary outcomes

Study Arms (2)

Topical ZAX.1400.P03

EXPERIMENTAL

ZAX.1400.P03, applied topically twice daily for 3 weeks after enrolment

Dietary Supplement: ZAX.1400.P03

Placebo

PLACEBO COMPARATOR

Placebo, applied topically twice daily for 3 weeks after enrolment

Drug: Placebo

Interventions

ZAX.1400.P03DIETARY_SUPPLEMENT

ZAX.1400.P03, applied twice daily for 3 weeks after enrolment

Topical ZAX.1400.P03
PlaceboDRUG

Placebo, applied twice daily for 3 weeks after enrolment

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of the disease by a doctor
  • Age range between 18 and 60 years
  • Both sexes (male and female)
  • Having written informed consent to participate in the study
  • Lack of allergy to food and health products
  • Only local tissue involvement and no need to take oral medications
  • Absence of underlying diseases and immune deficiency
  • Absence of pregnancy and breastfeeding
  • Absence of blisters and infection caused by the disease

You may not qualify if:

  • Non-consent of the doctor directly responsible for the patient
  • Incidence of drug product allergy
  • Occurrence of symptoms of skin, digestive, liver or kidney diseases
  • Patient\'s lack of consent to continue for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fasa university of medical sciences

Fasa, Fars, 7461686688, Iran

Location

MeSH Terms

Conditions

PsoriasisInflammationSkin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle-Investigator

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 8, 2024

Study Start

February 1, 2023

Primary Completion

June 30, 2025

Study Completion

July 30, 2025

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations

IR(1)