Back to resultsUsing Acetylcysteine and Vitamin E With Psoriasis Vulgaris
Primary Purpose
Psoriasis Vulgaris
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Acetyl cysteine
Vitamin E
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- Al-Haud Al-Marsoud HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
mix acetylcysteine with vitamin E
acetylcysteine
standard treatment alone
Arm Description
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
Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral effervescent sachet, 30 minutes before breakfast, for 8 weeks
Standard treatment for mild psoriatic patients (topical steroid and salicylic acid
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05906498
Brief Title
Using Acetylcysteine and Vitamin E With Psoriasis Vulgaris
Official Title
Evaluation of the Effect of Acetylcysteine and Vitamin E on Psoriasis Vulgaris Patients During The Active Phase
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Badr University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mix acetylcysteine with vitamin E
Arm Type
Active Comparator
Arm Description
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
Arm Title
acetylcysteine
Arm Type
Active Comparator
Arm Description
Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral effervescent sachet, 30 minutes before breakfast, for 8 weeks
Arm Title
standard treatment alone
Arm Type
No Intervention
Arm Description
Standard treatment for mild psoriatic patients (topical steroid and salicylic acid
Intervention Type
Drug
Intervention Name(s)
Acetyl cysteine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Intervention Description
vitamin E possessing an anti-inflammatory action
Primary Outcome Measure Information:
Title
level of interleukin-36(IL-36 gamma) (Pg/ml)
Description
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
Title
level of Malondialdehyde (MDA) (µmol/L)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nira Elkalla
Phone
+201120862904
Email
nayera.hassan@buc.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Amal Elkhouly
Phone
01060355448
Ext
+2
Email
Amal.elkhouly@pharma.asu.edu.eg
Facility Information:
Facility Name
Al-Haud Al-Marsoud Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed sadek
Phone
0223910898
Ext
+2
12. IPD Sharing Statement
Citations:
PubMed Identifier
25525775
Citation
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.
Results Reference
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PubMed Identifier
12602965
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.
Results Reference
background
PubMed Identifier
24790736
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.
Results Reference
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Using Acetylcysteine and Vitamin E With Psoriasis Vulgaris
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