NCT06758752

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
8mo left

Started Oct 2023

Typical duration for phase_2

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 Progress80%
Oct 2023Dec 2026

Study Start

First participant enrolled

October 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

January 6, 2025

Status Verified

September 1, 2024

Enrollment Period

3.2 years

First QC Date

December 28, 2024

Last Update Submit

December 28, 2024

Conditions

EczemaAtopic DermatitisInflammation

Keywords

EczemaAtopic DermatitisInflammationAnti-inflammatoryHerbal medicinesNatural Products

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.EC.02

EXPERIMENTAL

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

Dietary Supplement: ZAX.1400.EC.02

Placebo

PLACEBO COMPARATOR

Placebo, applied topically twice daily for 3 weeks after enrolment

Drug: Placebo

Interventions

ZAX.1400.EC.02DIETARY_SUPPLEMENT

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

Topical ZAX.1400.EC.02
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
  • 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
  • Patients 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

EczemaDermatitis, AtopicInflammation

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHypersensitivity, ImmediateHypersensitivityImmune System 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

December 28, 2024

First Posted

January 6, 2025

Study Start

October 1, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 6, 2025

Record last verified: 2024-09

Locations

IR(1)