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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05906498
Other study ID # Acetylcysteine in Psoriasis
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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