Clinical trial NCT06301997: A Herbal Compound for Psoriasis
Official title: Evaluation of Therapeutic Effects of ZAX.1400.P03 a Herbal Compound on Clinical Signs of Skin in Psoriasis Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Psoriasis
Inflammation
Skin Diseases
Keywords: Skin Diseases
Psoriasis
Herbal Medicines
Anti-inflammatory
Natural Products
Inflammation
Lead sponsor: Fasa University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Zarrin Avaye Kowsar Salamat (ZAX company) and HerbmedX
name: Herbmedx Co
First posted: 2024-03-08
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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\&#39;s lack of consent to continue for any reason

Primary outcomes:
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, and 6
Secondary outcomes:
measure: Change From Baseline in Percent Body Surface Area (%BSA) at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, and 6
measure: Change From Baseline in erythema score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, and 6
measure: Change From Baseline in Swelling score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, and 6
measure: Change From Baseline in pruritus score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, and 6
measure: Change From Baseline in flake score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, and 6
measure: Change From Baseline in skin dryness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, and 6
measure: Change From Baseline in skin irritation score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, and 6
measure: Change From Baseline in pain score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, and 6
measure: Change From Baseline in skin scratch score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, and 6
measure: Change From Baseline in skin scar score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, and 6
measure: Change From Baseline in skin thickness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, and 6
measure: Change From Baseline in skin rashes score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, and 6
Other outcomes:
Locations:
city: Fasa
country: Iran, Islamic Republic of
facility: Fasa university of medical sciences
state: Fars
Study officials:
References: