Using Acetylcysteine and Vitamin E With Psoriasis Vulgaris

NCT05906498 | Unknown Phase 3

• 1 other identifier: Acetylcysteine in Psoriasis
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

mix acetylcysteine with vitamin E

ACTIVE COMPARATOR

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; Drug: Vitamin E

acetylcysteine

ACTIVE COMPARATOR

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

standard treatment alone

NO INTERVENTION

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

Interventions

Acetyl cysteine DRUG

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.

acetylcysteine; mix acetylcysteine with vitamin E

Vitamin E DRUG

vitamin E possessing an anti-inflammatory action

mix acetylcysteine with vitamin E

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Badr University: lead

Study Sites (1)

Al-Haud Al-Marsoud Hospital

Cairo, Egypt

RECRUITING

Related 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.

  PMID: 25525775 BACKGROUND

• 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.

  PMID: 12602965 BACKGROUND

• 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.

  PMID: 24790736 BACKGROUND

MeSH Terms

Interventions

Acetylcysteine; Vitamin E

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Nira Elkalla

CONTACT

+201120862904; nayera.hassan@buc.edu.eg

Amal Elkhouly

CONTACT

01060355448; Amal.elkhouly@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant of clinical pharmacy department at BUC

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 18, 2023
• Study Start: December 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

EG (1)