Using Acetylcysteine and Vitamin E With Psoriasis Vulgaris

NCT ID: NCT05906498

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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

Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Acetyl cysteine

Intervention Type 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.

Vitamin E

Intervention Type DRUG

vitamin E possessing an anti-inflammatory action

acetylcysteine

Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral effervescent sachet, 30 minutes before breakfast, for 8 weeks

Group Type ACTIVE_COMPARATOR

Acetyl cysteine

Intervention Type 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.

standard treatment alone

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Vitamin E

vitamin E possessing an anti-inflammatory action

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Badr University

OTHER

Sponsor Role lead

Responsible Party

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Naira abbas hassan Elkalla

teaching assistant of clinical pharmacy department at BUC

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Haud Al-Marsoud Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nira Elkalla

Role: CONTACT

+201120862904

Amal Elkhouly

Role: CONTACT

01060355448 ext. +2

Facility Contacts

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ahmed sadek

Role: primary

0223910898 ext. +2

References

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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.

Reference Type BACKGROUND
PMID: 25525775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12602965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24790736 (View on PubMed)

Other Identifiers

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Acetylcysteine in Psoriasis

Identifier Type: -

Identifier Source: org_study_id

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