A Herbal Compound for Psoriasis

Evaluation of Therapeutic Effects of ZAX.1400.P03 a Herbal Compound on Clinical Signs of Skin in Psoriasis Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Skin Diseases; Inflammation; Psoriasis
• Intervention / Treatment: Dietary supplement: ZAX.1400.P03; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Fasa, Fars, Iran, Islamic Republic of, 7461686688
      • Fasa university of medical sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical ZAX.1400.P03; ZAX.1400.P03, applied topically twice daily for 3 weeks after enrolment	Dietary supplement: ZAX.1400.P03; ZAX.1400.P03, applied twice daily for 3 weeks after enrolment
Placebo Comparator: Placebo; Placebo, applied topically twice daily for 3 weeks after enrolment	Drug: Placebo; Placebo, applied twice daily for 3 weeks after enrolment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Percent Body Surface Area (%BSA) at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared %Body Surface Area Affected the "Rule of Nine" was be used	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	Erythema score will be assessed 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	Swelling score will be assessed 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	Pruritus score will be assessed 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	Flake score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Change From Baseline in skin dryness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Skin dryness score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Change From Baseline in skin irritation score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Skin irritation score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Change From Baseline in pain score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Pain score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Change From Baseline in skin scratch score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Skin scratch score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Change From Baseline in skin scar score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Skin scar score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Change From Baseline in skin thickness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Skin thickness score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Change From Baseline in skin rashes score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Skin rashes score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6

Collaborators and Investigators

• Sponsor: Fasa University of Medical Sciences
• Collaborators: Herbmedx Co; Zarrin Avaye Kowsar Salamat (ZAX company) and HerbmedX

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation; Psoriasis; Anti-inflammatory; Skin Diseases; Natural Products; Herbal Medicines
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases, Papulosquamous; Inflammation; Psoriasis; Skin Diseases
• Other Study ID Numbers: IRCT20210218050404N5; IR.FUMS.REC.1400.125 (Other Identifier: Fasaums)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No