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EczemaPhase 2NCT06758752

A Herbal Compound for Eczema

A Phase 2 study testing ZAX.1400.EC.02 in people with Eczema and Atopic Dermatitis, run by Fasa University of Medical Sciences at 1 site in Iran.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Eczema, Atopic Dermatitis, Inflammation
What is being tested?
ZAX.1400.EC.02
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 siteIran
Study dates
1 Oct 2023to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Fasa university of medical sciences

    Fasa, Fars, 7461686688

Other trials in Iran

About this study

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

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.

Being tested
ZAX.1400.EC.02, Placebo
Keywords
Eczema, Atopic Dermatitis, Inflammation, Anti-inflammatory, Herbal medicines, Natural Products
Medical subject headings
Eczema, Dermatitis, Atopic, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZAX.1400.EC.02Dietary supplement

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

  • PlaceboDrug

    Placebo, applied twice daily for 3 weeks after enrolment

Study groups in NCT06758752
Study groupRoleWhat they receive
Topical ZAX.1400.EC.02ExperimentalZAX.1400.EC.02, applied topically twice daily for 3 weeks after enrolment
Receives: Dietary Supplement: ZAX.1400.EC.02
PlaceboPlacebo comparatorPlacebo, applied topically twice daily for 3 weeks after enrolment
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (12)

  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. 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

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

  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

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

  7. 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

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

  8. 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

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

  9. 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

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

  10. 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

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

  11. 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

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

  12. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start1 Oct 2023
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06758752
Sponsor's protocol ID
IRCT20210218050404N3
Status last verified
Sep 2024
First submitted
28 Dec 2024
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZAX.1400.EC.02 in people with Eczema and Atopic Dermatitis, run by Fasa University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06758752.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.

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