Clinical trial NCT06508372: Topical Thymoquinone in Psoriasis Vulgaris
Official title: Efficacy and Safety of Thymoquinone Ointment as a Potential New Therapeutic Modality of Psoriasis Vulgaris.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psoriasis Vulgaris
Keywords: topical thymoquinone
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Psoriasis severity score (TES) assessment
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of treatment adverse effects
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.