Clinical trial NCT04071106: Turmeric Based Therapy in the Treatment of Psoriasis: A Clinical Trial
Official title: Turmeric Based Therapy in the Treatment of Psoriasis: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
Turmeric
Curcumin
Olive oil
Dermoscopy
NFkB
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-08-28
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Five groups will be included in the study Group 1: 10 Psoriatic patients receive turmeric extract based ointment . Group 2: 10 psoriatic patients will receive turmeric extract + olive oil based ointment.

Group 3: 10 psoriatic patients will receive petrolatum base as negative control.

Group 4: 10 psoriatic patients will receive NBUVB as positive control. Group 5: 10 psoriatic patients will receive established topical treatment serving as 2nd positive control.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with mild to moderate psoriasis vulgaris of any age \& gender.
2. Patient didn't receive any systemic or topical therapy for psoriasis the last 4 weeks.

Exclusion Criteria:

1. Patients previously received topical or systemic therapy for psoriasis in the past 4 weeks.
2. Patients with pustular or erythrodermic psoriasis.
3. Patients with other dermatological diseases.
4. Patients have hypersensitivity from the active ingredients of the therapy.

Primary outcomes:
measure: Change in Psoriasis Area & Severity Index (PASI)
timeFrame: 12 weeks
measure: Change on pathology level
timeFrame: Baseline and every 4 weeks for the period of the study (12 w)
measure: Change in NFϰB expression
timeFrame: Baseline and every 4 weeks till the end of 12 weeks.
measure: Change in psoriasis severity
timeFrame: Weekly basis for 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assistant lecturer
name: Hagar Nofal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Avramidis G, Kruger-Krasagakis S, Krasagakis K, Fragiadaki I, Kokolakis G, Tosca A. The role of endothelial cell apoptosis in the effect of etanercept in psoriasis. Br J Dermatol. 2010 Nov;163(5):928-34. doi: 10.1111/j.1365-2133.2010.09935.x.
citation: Cai Y, Fleming C, Yan J. Dermal gammadelta T cells--a new player in the pathogenesis of psoriasis. Int Immunopharmacol. 2013 Jul;16(3):388-91. doi: 10.1016/j.intimp.2013.02.018. Epub 2013 Mar 13.
citation: Camacho-Barquero L, Villegas I, Sanchez-Calvo JM, Talero E, Sanchez-Fidalgo S, Motilva V, Alarcon de la Lastra C. Curcumin, a Curcuma longa constituent, acts on MAPK p38 pathway modulating COX-2 and iNOS expression in chronic experimental colitis. Int Immunopharmacol. 2007 Mar;7(3):333-42. doi: 10.1016/j.intimp.2006.11.006. Epub 2006 Dec 18.
citation: Coimbra S, Figueiredo A, Castro E, Rocha-Pereira P, Santos-Silva A. The roles of cells and cytokines in the pathogenesis of psoriasis. Int J Dermatol. 2012 Apr;51(4):389-95; quiz 395-8. doi: 10.1111/j.1365-4632.2011.05154.x.
citation: Goldminz AM, Au SC, Kim N, Gottlieb AB, Lizzul PF. NF-kappaB: an essential transcription factor in psoriasis. J Dermatol Sci. 2013 Feb;69(2):89-94. doi: 10.1016/j.jdermsci.2012.11.002. Epub 2012 Nov 14.