Topical Thymoquinone in Psoriasis Vulgaris

Efficacy and Safety of Thymoquinone Ointment as a Potential New Therapeutic Modality of Psoriasis Vulgaris.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Topical thymoquinone Ointment; Drug: topical placebo ointment

Detailed Description

Psoriasis is a systemic chronic relapsing immune-mediated disease which often requires a long-term therapy. Psoriasis occurs in around 2-3% of the total global population. In Egypt, the prevalence of psoriasis ranges between 0.19% and 3%.

Besides, it could have profound implications on the patients' psychological state and quality of life.

It is presented by erythematous, scaly plaques over the preferred sites. The pathogenesis of this highly complex disease is still far from being fully understood. Keratinocytes' hyperproliferation and immune system dysfunctions are well recognized contributors, with numerous treatments targeting these unique immunologic dysfunctions.

Topical therapy for psoriasis is a current trending subject as it implies good compliance for the patient, few adverse systemic reactions and a targeted effect. Numerous substances are now being tested, from natural to synthetic compounds and already known substances in improved formulas such as vesicular systems.

Nigella sativa belongs to the Ranunculaceae family is an annual plant which distributed in southern Europe and some parts of Asia, including Syria, Turkey, Saudi Arabia, Pakistan, and India. Different active pharmaceutical ingredients have been identified in the N. sativa seeds, including saponins, flavonoids, cardiac glycosides, thymoquinone, thymol, limonene, carvacrol, p-cymene, alpha-pinene, 4-terpineol, longifolene, t-anethole benzene, isoquinoline, and pyrazole alkaloids, as well as unsaturated fatty acid such as linoleic acid, oleic acid, and palmitic acid.

Thymoquinone is the major bioactive ingredient, accounting for 30-48% of the essential oil, has high antioxidant and anti-inflammatory, immune-boosting, cell survival-improving, and energy metabolism-promoting properties, which may explain why they are so beneficial to our health. The anti-inflammatory properties of black seeds and thymoquinone are primarily mediated by COX-2 and PGD2 inhibition.

Clinical trials on skin disorders have shown that N. sativa essential oil and crude extract are effective. (Atopic dermatitis, Atopic eczema,Wart, Eczema, Acne vulgaris, Acute cutaneous leshmaniasis, Arsenical keratosis, Psoriasis, Vitiligo, Infant skin infections, Acute radiation dermatitis) It can be applied as an alternative treatment that helps patients with skin-related problems

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba Hassan, MD; Phone Number: 01002866919; Email: hebahasan16888@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: topical thymoquinone ointment; 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; 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.
Placebo Comparator: topical placebo ointment; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of treatment adverse effects	Any local or systemic side effects will be reported to evaluate the safety of Thymoquinone ointment for treatment of localized plaque psoriasis	3 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: topical thymoquinone
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: Topical thymoquinone

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No