A Herbal Compound for Eczema

Fasa University of Medical Sciences

Status and phase: Active, not recruiting; Phase 2

Conditions: Atopic Dermatitis; Inflammation; Eczema

Treatments: Drug: Placebo; Dietary Supplement: ZAX.1400.EC.02

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06758752

IRCT20210218050404N3

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups, including a placebo group

Topical ZAX.1400.EC.02

Experimental group

Description:

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

Treatment:

Dietary Supplement: ZAX.1400.EC.02

Placebo

Placebo Comparator group

Description:

Placebo, applied topically twice daily for 3 weeks after enrolment

Treatment:

Drug: Placebo