Clinical trial NCT05906498: Using Acetylcysteine and Vitamin E With Psoriasis Vulgaris
Official title: Evaluation of the Effect of Acetylcysteine and Vitamin E on Psoriasis Vulgaris Patients During The Active Phase
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Psoriasis Vulgaris
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: level of interleukin-36(IL-36 gamma) (Pg/ml)
timeFrame: 4 months
measure: level of Malondialdehyde (MDA) (µmol/L)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Haud Al-Marsoud Hospital
Study officials:
References:
citation: D'Erme AM, Wilsmann-Theis D, Wagenpfeil J, Holzel M, Ferring-Schmitt S, Sternberg S, Wittmann M, Peters B, Bosio A, Bieber T, Wenzel J. IL-36gamma (IL-1F9) is a biomarker for psoriasis skin lesions. J Invest Dermatol. 2015 Apr;135(4):1025-1032. doi: 10.1038/jid.2014.532. Epub 2014 Dec 19.
citation: Yildirim M, Inaloz HS, Baysal V, Delibas N. The role of oxidants and antioxidants in psoriasis. J Eur Acad Dermatol Venereol. 2003 Jan;17(1):34-6. doi: 10.1046/j.1468-3083.2003.00641.x.
citation: Rizvi S, Raza ST, Ahmed F, Ahmad A, Abbas S, Mahdi F. The role of vitamin e in human health and some diseases. Sultan Qaboos Univ Med J. 2014 May;14(2):e157-65. Epub 2014 Apr 7.