Inflammation, Psoriasis, Skin Diseases
Conditions
Keywords
Skin Diseases, Psoriasis, Herbal Medicines, Anti-inflammatory, Natural Products, Inflammation
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.
Interventions
DIETARY_SUPPLEMENTZAX.1400.P03
ZAX.1400.P03, applied twice daily for 3 weeks after enrolment
DRUGPlacebo
Placebo, applied twice daily for 3 weeks after enrolment
Sponsors
Zarrin Avaye Kowsar Salamat (ZAX company) and HerbmedX
Herbmedx Co
Fasa University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Dermatology Life Quality Index (DLQI) score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 | DLQI score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in erythema score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 | Erythema score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 |
| Change From Baseline in Swelling score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 | Swelling score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 |
| Change From Baseline in pruritus score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 | Pruritus score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 |
| Change From Baseline in flake score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 | Flake score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 |
| Change From Baseline in skin dryness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 | Skin dryness score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 |
| Change From Baseline in Percent Body Surface Area (%BSA) at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 | 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 |
| Change From Baseline in pain score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 | Pain score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 |
| Change From Baseline in skin scratch score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 | Skin scratch score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 |
| Change From Baseline in skin scar score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 | Skin scar score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 |
| Change From Baseline in skin thickness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 | Skin thickness score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 |
| Change From Baseline in skin rashes score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 | Skin rashes score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 |
| Change From Baseline in skin irritation score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 | Skin irritation score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 |
Countries
Iran
Outcome results
None listed