Using Acetylcysteine and Vitamin E With Psoriasis Vulgaris

Badr University

Status and phase: Enrolling; Phase 3

Conditions: Psoriasis Vulgaris

Treatments: Drug: Vitamin E; Drug: Acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT05906498

Acetylcysteine in Psoriasis

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult Patients from 18 to 65 years.
2. Gender: both males and females.
3. Mild psoriatic patients in the active phase (score < =3)
4. Patients diagnosed with mild psoriasis in the active phase (score less than or equal 3) using PASI score.

Exclusion criteria

1. Inactive psoriasis vulgaris patients.
2. Alcohol consumption
3. Any other autoimmune diseases.
4. Pregnant or lactating women.
5. Patients with serious illness and any systemic failure (cardiovascular, renal, or respiratory)
6. Patients with major psychiatric or mental illness.
7. Intake of any antioxidants in the previous 3 months
8. Patients of chronic diseases, like hypertension, heart problems
9. Patients with history of bleeding, ulcers, or uncontrollable heartburn.
10. Patients taking anticancer medications that can aggravate psoriasis vulgaris such as mercaptopurine, vinblastine, actinomycin, and Radiation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

mix acetylcysteine with vitamin E

Active Comparator group

Description:

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

Treatment:

Drug: Vitamin E

Drug: Acetyl cysteine

acetylcysteine

Active Comparator group

Description:

Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral effervescent sachet, 30 minutes before breakfast, for 8 weeks

Treatment:

Drug: Acetyl cysteine

standard treatment alone

No Intervention group

Description:

Standard treatment for mild psoriatic patients (topical steroid and salicylic acid