Using Acetylcysteine and Vitamin E With Psoriasis Vulgaris

Study Overview
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Brief Summary
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This study aims to assess the effect of adding N-acetyl cysteine (NAC) alone or in combination with Vitamin E to conventional therapy in improving the clinical outcome, oxidative stress, and inflammation in patients with mild psoriasis vulgaris

Detailed Description
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The study will include 60 Mild psoriatic patients in the active phase (score <, =3) using PASI score. The PASI is a widely used instrument that assesses and grades the severity of psoriatic lesions and the patient's response to treatment. They will assigned randomly into 3 groups. Each group will contain 20 patients. the first group will receive Standard treatment for mild psoriatic patients (topical steroid and salicylic acid), the second group will receive Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral, 30 minutes before breakfast, for 8 weeks. the third group will receive Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral effervescent sachet,30 minutes before breakfast Plus, vitamin E (1000 mg) daily, oral soft gelatin capsule for 8 weeks. PASI=Psoriasis Area and Severity Index

Official Title
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Evaluation of the Effect of Acetylcysteine and Vitamin E on Psoriasis Vulgaris Patients During The Active Phase

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: Acetyl cysteine
* Drug: Vitamin E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Patients from 18 to 65 years. Gender: both males and females. Mild psoriatic patients in the active phase (score < =3) Patients diagnosed with mild psoriasis in the active phase (score less than or equal 3) using PASI score. Exclusion Criteria: Inactive psoriasis vulgaris patients. Alcohol consumption Any other autoimmune diseases. Pregnant or lactating women. Patients with serious illness and any systemic failure (cardiovascular, renal, or respiratory) Patients with major psychiatric or mental illness. Intake of any antioxidants in the previous 3 months Patients of chronic diseases, like hypertension, heart problems Patients with history of bleeding, ulcers, or uncontrollable heartburn. Patients taking anticancer medications that can aggravate psoriasis vulgaris such as mercaptopurine, vinblastine, actinomycin, and Radiation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mix acetylcysteine with vitamin E<br>Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral effervescent sachet,30 minutes before breakfast Plus, vitamin E (1000 mg) daily, oral soft gelatin capsule for 8 weeks | Drug: Acetyl cysteine<br>* N-acetyl cysteine (NAC) is synthetic cysteine amino acid, which in turn elevate the glutathione level in the body, which have important direct antioxidant activity.<br>Drug: Vitamin E<br>* vitamin E possessing an anti-inflammatory action<br>|
| Active Comparator: acetylcysteine<br>Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral effervescent sachet, 30 minutes before breakfast, for 8 weeks | Drug: Acetyl cysteine<br>* N-acetyl cysteine (NAC) is synthetic cysteine amino acid, which in turn elevate the glutathione level in the body, which have important direct antioxidant activity.<br>|
| No Intervention: standard treatment alone<br>Standard treatment for mild psoriatic patients (topical steroid and salicylic acid | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of interleukin-36(IL-36 gamma) (Pg/ml) | measuring level of interleukin-36(IL-36 gamma) at baseline before the intervention and during taking the intervention and 1 month after stopping taking the intervention | 4 months | 
| level of Malondialdehyde (MDA) (µmol/L) | measuring level of malondialdehyde (MDA) at baseline before the intervention and during taking the intervention and 1 month after stopping taking the intervention | 4 months |