A Herbal Compound for Psoriasis

Inflammation Clinical Trial

Official title:

Evaluation of Therapeutic Effects of ZAX.1400.P03 a Herbal Compound on Clinical Signs of Skin in Psoriasis Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06301997
• Other study ID #: IRCT20210218050404N5
• Secondary ID: IR.FUMS.REC.1400
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Fasa University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: December 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Psoriasis
• Skin Diseases

Intervention

Dietary Supplement:
• ZAX.1400.P03
ZAX.1400.P03, applied twice daily for 3 weeks after enrolment

Drug:
• Placebo
Placebo, applied twice daily for 3 weeks after enrolment

Locations

Country	Name	City	State
Iran, Islamic Republic of	Fasa university of medical sciences	Fasa	Fars

Sponsors (2)

Lead Sponsor	Collaborator
Fasa University of Medical Sciences	Zarrin Avaye Kowsar Salamat (ZAX company)

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Secondary	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	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Secondary	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	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Secondary	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	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Secondary	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	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Secondary	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	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Secondary	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	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Secondary	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	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Secondary	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	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Secondary	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	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Secondary	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	Baseline and Weeks 1, 2, 3, 4, 5, and 6
Secondary	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	Baseline and Weeks 1, 2, 3, 4, 5, and 6