CClinicalTrials.gg
RecruitingNCT05906498Updated Jun 18, 2023

Using Acetylcysteine and Vitamin E With Psoriasis Vulgaris

A Phase 3 interventional study of Acetyl cysteine and Vitamin E in Psoriasis Vulgaris, sponsored by Badr University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by Badr University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Dec 2022, registered Jun 2023).
  • Started Dec 2022; still recruiting 3 years 10 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Psoriasis Vulgaris

Browse trials for

03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Badr University is the lead sponsor of 60 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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 · Drug: Vitamin E

  • 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

  • No intervention
    standard treatment alone

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

Interventions

  • DrugAcetyl 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.

  • DrugVitamin E

    vitamin E possessing an anti-inflammatory action

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 months

  2. 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

    Time frame: 4 months

07

Study locations

1 of 1 sites recruiting
  • Al-Haud Al-Marsoud Hospital
    Cairo, Egypt
    • ahmed sadek · Contact · 0223910898
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25525775 ↗
  • 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. PubMed 12602965 ↗
  • 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. PubMed 24790736 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05906498
Lead sponsor
Badr University
Responsible party
Naira abbas hassan Elkalla (teaching assistant of clinical pharmacy department at BUC, Badr University) — Principal investigator
First posted
Jun 18, 2023
Start date
Dec 1, 2022
Primary completion
Nov 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Jun 18, 2023

Study contacts

Nira Elkalla
Contact
nayera.hassan@buc.edu.eg
+201120862904
Amal Elkhouly
Contact
Amal.elkhouly@pharma.asu.edu.eg
01060355448 ext. +2

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion