Using Acetylcysteine and Vitamin E With Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906498
• Other study ID #: Acetylcysteine in Psoriasis
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: June 2023
• Source: Badr University
• Contact: Nira Elkalla
• Phone: +201120862904
• Email: nayera.hassan[@]buc.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Acetyl cysteine
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.
• Vitamin E
vitamin E possessing an anti-inflammatory action

Locations

Country	Name	City	State
Egypt	Al-Haud Al-Marsoud Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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