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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04071106
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Hagar Nofal, Zagazig University

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Turmeric Extract Drug: Turmeric Extract in Olive oil Drug: Petrolatum Device: NB-UVB Drug: calcipotriol/ Betamethasone Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: The patients do not know whether they are receiving the drugs with active ingredients or negative control. The pathologist will be masked regarding the groups and the point of time before or after therapy.
Primary Purpose: Treatment
Official Title: Turmeric Based Therapy in the Treatment of Psoriasis: A Clinical Trial
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: Turmeric Extract group
10 psoriasis patients receiving turmeric based ointment levigated in glycerin twice daily and assessed for response and side effects weekly for 12 weeks
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

Active Comparator: Turmeric extract + olive oil group
10 psoriasis patients receiving turmeric extract levigated in olive oil instead of glycerin. The ointment will be applied twice daily for 12 weeks & will be assessed weekly
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

Placebo Comparator: Petrolatum group
10 Psoriasis patients will receive the base of the therapeutic ointment which is the petrolatum. Patients will apply it twice daily and will be assessed weekly clinically and dermoscopically for 12 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

Active Comparator: NBUVB group
10 Psoriasis patients will receive two sessions of NBUVB weekly for 12 weeks and will be assessed weekly clinically and with dermoscope.
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

Active Comparator: Established ttt group
10 Psoriasis patients will receive topical betamethasone dipropionate or calcipotriol cream twice daily for 12 weeks and will be assessed on weekly basis clinically and by dermoscope
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




Primary Outcome Measures :
  1. Change in Psoriasis Area & Severity Index (PASI) [ Time Frame: 12 weeks ]
    Response to therapy is assessed via measurement of (PASI) every week for 12 w. The range of PASI score is from 0 (no disease) - 72 (sever disease). In PASI, the body is divided into four sections (head; arms; trunk; legs). Each of the sections is scored by itself, and then the four scores are combined into the final PASI. For each section, area of involved skin is given a grade from 0 to 6: 0= 0% of involved area, 1 = < 10% involved, 2=10-29% involved, 3 =30-49% involved area, 4 = 50-69% involved, 5 =70-89% involved, 6 = 90-100%involved. Within each section, the severity is estimated in three clinical parameters: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum. The sum of three severity parameters is calculated for each section of body, multiplied by the area score for that section and multiplied by weight of respective section (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs).

  2. Change on pathology level [ Time Frame: Baseline and every 4 weeks for the period of the study (12 w) ]
    Histopathologic evaluation of hematoxylin and eosin stained slides from psoriatic lesions before and after treatment or placebo. The slides will be given a score based on the presence or absence of each of the following: Hyperkeratosis (0.5), One mitosis/3 rete ridges (0·5), Acanthosis (1),Dermis lymphocytic infiltrate; Mild (0·5) Moderate (1) Marked (2·0) Parakeratosis (1),Papillary congestion (0.5),Lack of granular layer (1), Munro abscesses (2), Thinning above the papillae (0.5), Length of rete ridges (0.5), Clubbing of rete ridges (0·5). The sum score of each patient's slide will be recorded at baseline & every 4 week

  3. Change in NFϰB expression [ Time Frame: Baseline and every 4 weeks till the end of 12 weeks. ]
    The NFϰB expression will be identified by the percentage of positive nuclear stained epidermal cells in slide at base line and every 4 weeks till the end of study which is 12 week

  4. Change in psoriasis severity [ Time Frame: Weekly basis for 12 weeks ]
    Response to therapy will be assessed using dermatoscope with software mediated image analysis.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071106


Contacts
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Contact: Hagar Nofal +201006387707 hagarnofal@aucegypt.edu

Sponsors and Collaborators
Zagazig University
Investigators
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Principal Investigator: Hagar Nofal Assistant lecturer
  Study Documents (Full-Text)

Documents provided by Hagar Nofal, Zagazig University:
Study Protocol  [PDF] August 24, 2019

Publications:
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Responsible Party: Hagar Nofal, Assistant Lecturer, Principal Investigator, Zagazig University
ClinicalTrials.gov Identifier: NCT04071106    
Other Study ID Numbers: ZU-IRB#3950-20-8-2017
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Analytic Code
Time Frame: 2 Years after the finish of the study

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Hagar Nofal, Zagazig University:
Psoriasis
Turmeric
Curcumin
Olive oil
Dermoscopy
NFkB
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone
Calcipotriene
Petrolatum
Turmeric extract
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Emollients