A Herbal Compound for Psoriasis

Fasa University of Medical Sciences

Status and phase: Active, not recruiting; Phase 2

Conditions: Psoriasis; Inflammation; Skin Diseases

Treatments: Dietary Supplement: ZAX.1400.P03; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06301997

IRCT20210218050404N5

IR.FUMS.REC.1400.125 (Other Identifier)

Details and patient eligibility

About

The goal of this interventional clinical trial study is to compare ZAX.1400.P03 and placebo in Psoriasis patients. The main question it aims to answer is:

• Can treatment with ZAX.1400.P03 for 3 weeks improve clinical signs of skin in psoriasis patients? Participants will be divided into two groups of 52 people. One group will use ZAX.1400.P03 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 psoriasis after treatment with ZAX.1400.P03 for 3 weeks.

Enrollment: 104 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
• Only local tissue involvement and no need to take oral medications
• 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
• Patient's 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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104 participants in 2 patient groups, including a placebo group

Topical ZAX.1400.P03

Experimental group

Description:

ZAX.1400.P03, applied topically twice daily for 3 weeks after enrolment

Treatment:

Dietary Supplement: ZAX.1400.P03

Placebo

Placebo Comparator group

Description:

Placebo, applied topically twice daily for 3 weeks after enrolment

Treatment:

Drug: Placebo