NCT04071106

Turmeric Based Therapy in the Treatment of Psoriasis: A Clinical Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Psoriasis affects around 4% of world population. The disease could be disabling and disfiguring dermatologic condition. World Health Organization (WHO) has recently drawn the attention to the inadequate treatment options psoriasis patients suffer from among other problems. Furthermore, the available treatment options have many side effects. A lot of the effective treatment options are either expensive or not appropriate for hepatic patients who represent a large subset of Egyptian psoriatic patients. This highlights the need for inexpensive and safe alternative. The effectiveness of Turmeric in psoriasis treatment have been addressed in few reports. Having an immune modulatory effect especially as anti NFκB it is expected to be effective therapy with minimal side effect. Up to the investigator's knowledge this is the first study addressing the efficacy of combined turmeric and olive oil based topical therapy in psoriasis treatment

Detailed description

Psoriasis is a prevalent skin disorder. It affects around 4% of world's population. It can be disfiguring and disabling in severe cases. There is dysregulated immune response in psoriatic patients to unknown injurious agents with upregulation of Th1/Th17 pathways which is mediated via Nuclear Factor kappa B (NFκB). NFκB is a key player in psoriasis development; its activation and nuclear translocation is present in every step of the way of psoriasis starting from keratinocyte release of cytokines -in response to stress- to the maturation and activation of dendritic cells, to the continuous loop of T cell activation. Turmeric extract has anti-inflammatory, anti-oxidant, anti-microbial and anti-carcinogenic effects. It has inhibitory effects on NF-κB and various cytokines production. In this clinical trial 5 groups of patients with mild to moderate psoriasis are recruited; group (A) Receiving the Turmeric extract based ointment only. Group (B) receiving Turmeric extract + olive oil based treatment. Group (C) will serve as negative control receiving only petrolatum base. Group (D) will receive NB UVB serving as positive control. Group (E) will receive established topical treatment serving as positive control. Each patient will be assessed on weekly bases clinically for the disease severity using PASI score and via dermatoscope. Histopathological evaluation (H\& E along with NFkB expression analysis) will be done at 4 points of time baseline, 4 weeks, 8 weeks, 12 weeks through the study.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Turmeric Extract	Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks
DRUG	Turmeric Extract in Olive oil	Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks
DRUG	Petrolatum	Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks
DEVICE	NB-UVB	Patients will receive 2 sessions of NB-UVB phototherapy and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks
DRUG	calcipotriol/ Betamethasone	Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks

Timeline

• Start date: 2019-09-01
• Primary completion: 2019-12-01
• Completion: 2019-12-31
• First posted: 2019-08-28
• Last updated: 2019-08-28

Regulatory

• FDA-regulated drug study