Topical Thymoquinone in Psoriasis Vulgaris

NCT06508372 | Not Yet Recruiting

• 1 other identifier: Topical thymoquinone
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

A previous trial found that N. sativa oil was more effective as an antipsoriatic agent, particularly when taken as both a cream and a pill. This confirmed that N. sativa possesses antipsoriatic properties and can alleviate psoriasis symptoms

Conditions

Psoriasis Vulgaris

Keywords

topical thymoquinone

Outcome Measures

Primary Outcomes (1)

• Psoriasis severity score (TES) assessment

  Psoriasis severity score (TES): It is a physician-based, four-point scoring system in which the thickness, erythema, and scales within each plaque will be rated from 0 (none) to 3 (severe)at baseline and to evaluate the therapeutic outcome of topical thymoquinone ointment in each follow up visit.

  3 months

Secondary Outcomes (1)

• Evaluation of treatment adverse effects

  3 months

Study Arms (2)

topical thymoquinone ointment

EXPERIMENTAL

One plaque on one side of the body per every patient will be selected, whose diameter would not exceed 5-10 cm2 to apply Thymoquinone ointment as a monotherapeutic ttt twice daily for 3 months.

Drug: Topical thymoquinone Ointment

topical placebo ointment

PLACEBO COMPARATOR

In each patient a single similar psoriatic plaque on the other side of the body \[as regard anatomical site, size and TES (thickness, erythema, scales) score\] will be treated with placebo ointment twice daily for 3 months as a control.

Drug: topical placebo ointment

Interventions

Topical thymoquinone Ointment DRUG

One plaque per patient on one side of the body will be selected, whose diameter would not exceed 5-10 cm2 to apply Thymoquinone ointment as a monotherapeutic ttt twice daily for 3 months.

topical thymoquinone ointment

topical placebo ointment DRUG

In each patient a single similar psoriatic plaque on the other side of the body \[as regard anatomical site, size and TES (thickness, erythema, scales) score\] will be treated with placebo ointment twice daily for 3 months as a control.

topical placebo ointment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with clinical diagnosis of mild psoriasis vulgaris
• Age: between 18 and 60 years' old
• Patients who stopped any systemic therapy or phototherapy for at least 3 months and topical therapy for at least 4 weeks prior to enrollment

You may not qualify if:

• Psoriasis vulgaris involving \> 10% of the body surface area, pustular or erythrodermic psoriasis.
• Pregnant or lactating females.
• Patients with any current dermatological disease.
• Patients with any current systemic disease.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Omar SS, Helaly HA. Prevalence of ocular findings in a sample of Egyptian patients with psoriasis. Indian J Dermatol Venereol Leprol. 2018 Jan-Feb;84(1):34-38. doi: 10.4103/ijdvl.IJDVL_1239_15.

  PMID: 29067934 BACKGROUND

Central Study Contacts

Heba Hassan, MD

CONTACT

01002866919; hebahasan16888@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Intrapatient randomized controlled study: Topical Thymoquinone ointment will be applied to one psoriatic plaque on one side of the body, while the placebo ointment will be applied to a similar psoriatic plaque on the other side of the body twice daily for 3 months. each patient is randomizied to receive topical thymoquinone ointment on either the left or the right side.

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 18, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share