Topical Thymoquinone in Psoriasis Vulgaris

NCT ID: NCT06508372

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-01-31

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

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

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Topical thymoquinone Ointment

Intervention Type: 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 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.

Group Type: PLACEBO_COMPARATOR

topical placebo ointment

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Heba Hasan Sayed

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Heba Hassan, MD

Role: CONTACT

hebahasan16888@yahoo.com

01002866919

References

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.

Reference Type: BACKGROUND

PMID: 29067934 (View on PubMed)

Other Identifiers

Topical thymoquinone

Identifier Type: -

Identifier Source: org_study_id