A Herbal Compound for Eczema

Phase 2

Active, not recruiting

• Conditions: Eczema; Atopic Dermatitis; Inflammation
• Interventions: Dietary Supplement: ZAX.1400.EC.02; Drug: Placebo

• Registration Number: NCT06758752
• Lead Sponsor: Fasa University of Medical Sciences

Brief Summary

The goal of this interventional clinical trial study is to compare ZAX.1400.EC.02 and placebo in Eczema patients. The main question it aims to answer is:

• Can treatment with ZAX.1400.EC.02 for 3 weeks improve clinical signs of skin in Eczema patients? Participants will be divided into two groups. One group will use ZAX.1400.EC.02 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 Eczema after treatment with ZAX.1400.EC.02 for 3 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-09
• Study First Submitted: 2024-12-28
• Study First Submitted QC: 2024-12-28
• Last Update Submitted: 2024-12-28
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

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
• 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
• Patients lack of consent to continue for any reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical ZAX.1400.EC.02	ZAX.1400.EC.02	ZAX.1400.EC.02, applied topically twice daily for 3 weeks after enrolment
Placebo	Placebo	Placebo, applied topically twice daily for 3 weeks after enrolment

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Dermatology Life Quality Index (DLQI) score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6	DLQI score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

Secondary Outcome Measures

Name	Time	Method
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	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
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	Erythema score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
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	Swelling score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
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	Pruritus score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
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	Flake score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
Change From Baseline in skin dryness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6	Skin dryness score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
Change From Baseline in skin irritation score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6	Skin irritation score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
Change From Baseline in pain score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6	Pain score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
Change From Baseline in skin scratch score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6	Skin scratch score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
Change From Baseline in skin scar score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6	Skin scar score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
Change From Baseline in skin thickness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6	Skin thickness score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
Change From Baseline in skin rashes score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42	Baseline and Weeks 1, 2, 3, 4, 5, and 6	Skin rashes score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

Trial Locations

Locations (1)

Fasa university of medical sciences; 🇮🇷 Fasa, Fars, Iran, Islamic Republic of