Using Acetylcysteine and Vitamin E With Psoriasis Vulgaris

June 13, 2023 updated by: Naira abbas hassan Elkalla, Badr University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Al-Haud Al-Marsoud Hospital
        • Contact:
          • ahmed sadek
          • Phone Number: +2 0223910898

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mix acetylcysteine with vitamin E
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
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.
Drug: Vitamin E
vitamin E possessing an anti-inflammatory action
Active Comparator: acetylcysteine
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
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.
No Intervention: standard treatment alone
Standard treatment for mild psoriatic patients (topical steroid and salicylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of interleukin-36(IL-36 gamma) (Pg/ml)
Time Frame: 4 months
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)
Time Frame: 4 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Badr University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

June 4, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Estimated)

June 16, 2023

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acetylcysteine in Psoriasis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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