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

NCT04071106 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: ZU-IRB#3950-20-8-2017
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Psoriasis

Keywords

Psoriasis; Turmeric; Curcumin; Olive oil; Dermoscopy; NFkB

Outcome Measures

Primary Outcomes (4)

• Change in Psoriasis Area & Severity Index (PASI)

  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).

  12 weeks

• Change on pathology level

  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

  Baseline and every 4 weeks for the period of the study (12 w)

• Change in NFϰB expression

  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

  Baseline and every 4 weeks till the end of 12 weeks.

• Change in psoriasis severity

  Response to therapy will be assessed using dermatoscope with software mediated image analysis.

  Weekly basis for 12 weeks

Study Arms (5)

Turmeric Extract group

ACTIVE COMPARATOR

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

Turmeric extract + olive oil group

ACTIVE COMPARATOR

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

Petrolatum group

PLACEBO COMPARATOR

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

NBUVB group

ACTIVE COMPARATOR

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

Established ttt group

ACTIVE COMPARATOR

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

Interventions

Turmeric Extract DRUG

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

Turmeric Extract group

Turmeric Extract in Olive oil DRUG

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

Turmeric extract + olive oil group

Petrolatum DRUG

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

Petrolatum group

NB-UVB DEVICE

Patients will receive 2 sessions of NB-UVB phototherapy and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks

NBUVB group

calcipotriol/ Betamethasone DRUG

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

Established ttt group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Related Publications (5)

• 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.

  PMID: 20633014 BACKGROUND

• 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.

  PMID: 23499509 BACKGROUND

• 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.

  PMID: 17276891 BACKGROUND

• 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.

  PMID: 22435425 BACKGROUND

• 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.

  PMID: 23219896 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

turmeric extract; Olive Oil; Petrolatum; calcipotriene; Betamethasone

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hydrocarbons; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Hagar Nofal

  Assistant lecturer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hagar Nofal

CONTACT

+201006387707; hagarnofal@aucegypt.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 28, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: 2 Years after the finish of the study