Efficacy and Safety of Thymoquinone Ointment as a Potential New Therapeutic Modality of Psoriasis Vulgaris.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 30
- Primary Endpoint
- Psoriasis severity score (TES) assessment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Topical thymoquinone Ointment (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: topical placebo ointment (Drug)
Outcomes
Primary Outcomes
Psoriasis severity score (TES) assessment
Time Frame: 3 months
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.
Secondary Outcomes
- Evaluation of treatment adverse effects(3 months)
Investigators
Heba Hasan Sayed
Doctor
Assiut University