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Active, Not Recruiting

NCT Number: NCT06758752

A Herbal Compound for Eczema

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Eczema Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fasa university of medical sciences

Fasa, Fars, 7461686688, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZAX.1400.EC.02

Dietary Supplement

ZAX.1400.EC.02, applied twice daily for 3 weeks after enrolment

Placebo

Drug

Placebo, applied twice daily for 3 weeks after enrolment

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  6. Change From Baseline in skin dryness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    Time frame: 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

  7. Change From Baseline in skin irritation score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    Time frame: 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

  8. Change From Baseline in pain score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    Time frame: 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

  9. Change From Baseline in skin scratch score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    Time frame: 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

  10. Change From Baseline in skin scar score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    Time frame: 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

  11. Change From Baseline in skin thickness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    Time frame: 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

  12. Change From Baseline in skin rashes score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fasa University of Medical Sciences

Other

Collaborators

  • Herbmedx Co
  • Zarrin Avaye Kowsar Salamat (ZAX company)

Registry information

Official study title

Evaluation of Therapeutic Effects of ZAX.1400.EC.02 a Herbal Compound on Clinical Signs of Skin in Eczema Patients

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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