Turmeric Based Therapy in the Treatment of Psoriasis: A Clinical Trial
Phase: PHASE2
Conditions: Psoriasis
Sponsor: Zagazig University

Turmeric Based Therapy in the Treatment of 
Psoriasis: A Clinical Trial
Date 24 August 2019
Study Protocol
HAGAR NOFAL
 
 

Introduction 
  
  
 Psoriasis is a prevalent skin disorder. It affects around 4% of world’s 
population. It can be disfiguring and disabling in severe cases. Psoriasis has 
been associated with many comorbidities e.g. increased cardiovascular risk, 
diabetes and metabolic syndrome (Cai et al., 2013; Mahil et al., 2016). 
The exact cause of psoriasis is still unknown, however, in a genetically 
susceptible individual there is evident dysregulated immune response to an 
unknown stimulus (Mitra et al., 2013; Mahil et al., 2016). There is 
dysregulation of the mechanisms present in the skin to upregulate or to down 
regulate the immune responses when needed (Wang et al., 2011). Such 
dysregulation results in abnormal continuous inflammatory loop observed in 
psoriasis. In psoriasis there are specific pathways continuously activated 
including Th1 pathway with TNFα, IL6 and IL 12 upregulation and Th17 
pathway with increased expression of IL17 and IL23. When exposed to 
environmental triggers, self-RNA and self-DNA released from stressed 
keratinocytes got complexed with  / Cathelicidine (LL37). The formed 
complexes interact with Toll like receptors (TLRs) of plasmacytoid dendritic 
cells (pDCs). On their activation, pDCs produce interferon-α  (IFN-α). INF-
α orchestrates the maturation of monocyte derived dendritic cells (moDCs). 
Moreover, self-RNA / LL37 complexes and viral ssRNA directly enhance 
the maturation of IFN-α-primed moDCs both on phenotypical and functional 
levels. The moDCs maturation is further promoted by TNF-α, IL-1β, INF-γ, 
IL-6, secreted from stressed keratinocytes, fibroblasts, lymphocytes, natural 
killer T cells and macrophages. Mature IFN-α-primed moDCs migrate to 
draining lymph nodes, where they drive naive T cell differentiation into Th1 

and/or Th17 cells through IL-12 and IL-23. These T cells migrate via 
lymphatic and blood vessels into psoriatic dermis and contribute to the 
formation of a psoriatic plaque (Farkas & Kemény, 2012).  
Nuclear factor κB (NF-κB) is a transcription factor that orchestrates 
inflammation and other complex biological processes including cellular 
proliferation, differentiation and apoptosis. It also controls various cytokines 
and chemokines production. It has a major role in psoriasis development; its 
activation and nuclear translocation is present in every step of the way of 
psoriasis starting from stressed keratinocyte release of cytokines to 
maturation and activation of dendritic cells to the continuous loop of T cell 
activation. Inducers of NF-κB include pro-inflammatory cytokines, such as 
TNF-α and IL-1, foreign antigens, such as carbohydrates and peptides 
recognized by pattern recognition molecules as TLRs (Goldminz et al., 
2013). Induction of NF-κB leads to its nuclear translocation with alteration 
of cell cycle and apoptosis in keratinocyte along with immune cell activation 
and cytokine release (Tsuruta, 2009). NF-κB is a central point in psoriasis 
pathogenesis and its level is elevated in psoriatic skin (Lizzul et al., 2005) 
and is reduced with successful treatment with anti TNF- α therapies (Lizzul 
et al., 2005; Avramidis et al., 2010). Glucocorticoids competitively inhibit 
NF-κB binding. NF-κB represents a potential target for antipsoriatic therapy 
(Goldminz et al., 2013).  
Curcuma longa (Linn) (turmeric) is a rhizomatous herbaceous plant. Its 
extract Curcumin (diferuloylmethane) has gained an increasing interest for 
its pro apoptotic properties inhibiting cell proliferation.  So it has been tested 
for its anticancer efficacy in animal models of pancreatic cancer, breast 
cancer, colorectal cancer and skin cancer (Kang et al., 2016). Turmeric 

extract has also showed phosphorylase kinase inhibition activity, hence an 
anti-inflammatory, anti-oxidant, anti-microbial and anti-carcinogenic effects. 
It has inhibitory effects on NF-κB and various cytokines production (Sun et 
al., 2013). Curcumin, the turmeric extract, inactivated NF-κB and 
subsequently reduced the expression of multiple proinflammatory cytokines 
including TNF-α, IL-1, IL- 2, IL-6, IL-8, and IL-12 (Sugimoto et al., 2002; 
Camacho-Barquero et al., 2007; Sun et al., 2013). Curcumin also 
suppresses the activation of other transcriptional factors including signal 
transducer and activator of transcription (STAT1, STAT3, and STAT4) (Sun 
et al., 2013). Both STAT3 & STAT4 are major contributors in T helper 
differentiation toward Th17 and Th1 respectively. STAT3 also regulate 
keratinocyte proliferation in psoriasis (Coimbra et al., 2012). Curcumin 
also has been proved to act as a potent blocker of different types of K 
channels. K channels play a very important role in T cell activation and 
differentiation. Blockers of K channels have been under investigation for 
autoimmune disease management in phase I clinical study (Kang et al., 
2016). 
The complex nature of psoriasis pathogenesis has imposed the need of 
many therapeutics. Each targets specific point in the disease pathogenesis. 
Despite the presence of various systemic and topical therapies, World Health 
Organization (WHO) global report on psoriasis has highlighted the psoriasis 
patients’ need to have more treatment options (World Health Organization 
(WHO), 2016). 
Turmeric extract has been used for ages in treatment of different diseases 
as part of alternative medicine. Its effectiveness has been studied in different 

dermatologic diseases e.g. acne, eczema, oral lichen planus and psoriasis 
(Vaughn et al., 2016).  
Many other natural remedies have been tried for treatment of psoriasis 
and other skin disease (Vaughn et al., 2016). There is a trend in patients to 
ask for herbal natural remedies as a safe, effective and affordable alternative 
or adjuvant to conventional therapeutics (Deng et al., 2013; Talbott et al., 
2015).  
Rationale 
• Psoriasis is a prevalent disabling and disfiguring dermatologic condition. 
WHO resolution on psoriasis has recognized the inadequate treatment 
options psoriasis patients suffer among other problems. 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.  
• Few reports are published on the effectiveness of Turmeric in psoriasis 
treatment. Having an immune modulatory effect especially as anti NFκB it 
is expected to be effective therapy with minimal side effect. 
• Up to our knowledge this is the first study addressing the efficacy of 
combined turmeric and olive oil based topical therapy in psoriasis 
treatment.  
 Research question 
What is the efficacy of Turmeric based topical therapy in the treatment of 
psoriasis? 

Hypothesis 
• Turmeric based therapy effectively treat psoriasis through reduction of 
NFκB expression in psoriatic skin.   
 
Aim 
The aim of this study is to verify the efficacy of Turmeric based therapy 
alone and combined with olive oil in the treatment of psoriasis. 
Objectives 
1- To evaluate the effectiveness of Turmeric extract based topical 
therapy for psoriasis 
2- To compare the effectiveness of Turmeric extract based therapy 
and combined Turmeric/Olive oil based therapy. 
3- To identify the effect of Turmeric based therapy of NFκB expression 
in psoriasis.  
Subjects and methods 
Technical design 
• Setting: Dermatology, Venereology & Andrology Department, 
Faculty of Medicine Zagazig University, Pathology Department, 
Faculty of Medicine Zagazig University. 
Study design:  
• Type of study: 

Clinical trial 
• Sample size:  
The sample size is calculated using OpenEpi with PASI score of the 
control group is 3.3 + 2 and of the Turmeric treated group is 1.4 + 1.1. 
So at power of study 80 % and CI 95% the sample size is calculated to 
be 40 with 10 subjects in each group. 
• Inclusion criteria 
     All participants must be willing to sign informed consent. 
     The study will include  
               For the patients group: 
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. 
For the control group: 
1- Psoriasis vulgaris patients (mild to moderate) of matching age 
and gender. 
2- Patients 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. 
• Study groups  
Four groups will be included in the study  
Group 1: 10 psoriatic patients will receive Turmeric extract based 
topical therapy for at least 4 weeks up to 12 weeks. 
Group 2: 10 psoriatic patients will receive Turmeric and Olive oil 
based topical therapy for at least 4 weeks up to 12 weeks. 
Group 3: 10 psoriatic patients will receive only the base topical 
therapy for at least 4 weeks up to 12 weeks. 
Group 4: 10 psoriatic patients will receive 2 sessions of NB-UVB 
every week for at least 4 weeks up to 12 weeks. 
Group 5: 10 psoriatic patients will receive daily Betamethasone or 
Calcipotriol every week for at least 4 weeks up to 12 weeks. 
Steps of study:  
• All study subjects will be subjected to:  
I. 
History Taking: Detailed history will be taken from patients 
regarding name, age, duration of disease, arthropathy, family 
history of the disease, other dermatologic conditions, other 
systemic diseases and drug history 
II. 
Clinical evaluation: Assessment of the psoriasis using PASI score. 
III. 
Dermoscopic evaluation: The psoriatic plaques will be assessed 
using dermoscope. The dermsoccopic criteria of psoriasis includes 
dotted vessels regulary distributed on light red background with 
white silvery scales homogenously distributed on the erythematous 
background.  

IV. 
Histopathologic assessment: 5 ml punch Skin biopsies will be 
obtained and immersed in 10% formalin then embedded in paraffin 
wax and processed for H&E staining. The diagnosis of psoriasis 
will be histologically confirmed. 
V. 
Immunohistochemical analysis: NFκB expression in the psoriatic 
skin will be evaluated before and after treatment using 
immunohistochemical stain.  
Administrative design 
All patients included in the study will provide written informed 
consent after being informed about the study steps, the possible 
complications and their capability to withdraw at any time after approval of 
Institutional Review Board Of Faculty of Medicine, Zagazig University.     
Results 
The collected data will be presented in tables and suitable graphs and 
the appropriate statistical methods will be applied. 
Discussion 
The obtained results will be discussed and compared to the available 
relevant literature and published scientific researches to explain them. 
 
Conclusion and recommendations    
Conclusion and recommendations derived from the results of the study 
will be presented. 
 
 

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