Formulation and Clinical Evaluation of Ethosomal and Liposomal Preparations of Anthralin in Psoriasis

NCT03348462 | Completed Phase 4

• 1 other identifier: faceoealpoaip
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Psoriasis is a common immune mediated inflammatory skin disease characterized by red heavily scaled plaques. Anthralin (1,8-dihydroxy-9-anthrone) which was introduced over 80 years ago has shown excellent efficacy in the management of psoriasis.Although anthralin is remarkably effective in the management of psoriasis, its side effects are equally disturbing. Its use is messy as it stains the skin, clothing, and any furniture that it may come in contact with. Further, anthralin has irritating, burning, brown discoloration and necrotizing effect on the normal and the diseased skin. This troublesome profile has discouraged wide-spread use of the drug. Ethosomes are attractive vesicular carriers mainly composed of phospholipids, ethanol and water. The intriguing features of ethosomes are due to their high ethanol content which facilitate their penetration through stratum corneum and target deep skin layers. This is advantageous over conventional liposomes which have limited penetration through the skin and remain confined in the upper layer of the stratum corneum. Compared to liposomes, ethosomes had greater retention of methotrexate into the skin for a longer period of time, suggesting better therapeutic outcome.

Conditions

Psoriasis Vulgaris

Keywords

psoriasis; anthralin; ethosome; liposome

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area and Severity Index (PASI) score

  PASI combines the assessment of the severity of psoriatic lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). PASI will be measured before and after treatment to assess the efficacy of therapy.Steps in generating PASI score 1. Divide body into four areas: head, arms, trunk, and legs . 2. Generate an average score for the erythema, thickness, and scaling for each of the 4 areas , each graded on a 0-4 scale (0 = clear, 1= slight,2= mild, 3=moderate, 4=severe). 3. Sum scores of erythema, thickness, and scale for each area. 4. Generate a percentage for skin covered with psoriasis for each area and convert that to a 0-6 scale (0 = 0%; 1 =,10%; 2 = 10-,30%; 3 = 30-,50%; 4 = 50- ,70%; 5 = 70-,90%; 6 = 90-100%). 5. Multiply score of item (c) above times item (d) above for each area and multiply that by 0.1, 0.2, 0.3, and 0.4 for head, arms, trunk, and legs, respectively. 6. Add these scores to get the PASI score.

  up to 8 weeks

Secondary Outcomes (4)

• Histopathological examination of psoriatic lesions using hematoxylin and eosin staining (H & E stain)

  up to 8 weeks

• Safety of the drug perparations

  up to 8 weeks

• Patient satisfaction

  up to 8 weeks

• digital photography

  up to 8 weeks

Study Arms (2)

ethosomal anthralin

EXPERIMENTAL

Group 1: included 10 psoriatic patients will be treated with ethosomal preparation of anthralin. Patients will be treated with this preparation with short contact (only one hour) daily up to 8 weeks.

Drug: ethosomal preparation of anthralin

liposomal anthralin

ACTIVE COMPARATOR

Group 2: included 10 psoriatic patients will be treated with liposomal preparation of anthralin. Patients will be treated with this preparation with short contact (only one hour) daily up to 8 weeks.

Drug: liposomal preparation of anthralin

Interventions

ethosomal preparation of anthralin DRUG

once daily with short contact topical application

ethosomal anthralin

liposomal preparation of anthralin DRUG

once daily with short contact topical application

liposomal anthralin

Eligibility Criteria

• Age: 9 Years - 70 Years
• 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, stable chronic plaque psoriasis.

You may not qualify if:

• patients with severe psoriasis.
• Patients received any topical or systemic treatment for psoriasis one month before the start of the study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71526, Egypt

Location

Related Publications (11)

• Hollywood KA, Winder CL, Dunn WB, Xu Y, Broadhurst D, Griffiths CE, Goodacre R. Exploring the mode of action of dithranol therapy for psoriasis: a metabolomic analysis using HaCaT cells. Mol Biosyst. 2015 Aug;11(8):2198-209. doi: 10.1039/c4mb00739e.

  PMID: 26018604 BACKGROUND

• Parish LC, Millikan LE, Witkowski JA. The modern story of anthralin. Int J Dermatol. 1989 Jul-Aug;28(6):373-4. doi: 10.1111/j.1365-4362.1989.tb02481.x. No abstract available.

  PMID: 2767834 BACKGROUND

• Saraswat A, Agarwal R, Katare OP, Kaur I, Kumar B. A randomized, double-blind, vehicle-controlled study of a novel liposomal dithranol formulation in psoriasis. J Dermatolog Treat. 2007;18(1):40-5. doi: 10.1080/09546630601028729.

  PMID: 17365266 BACKGROUND

• McGill A, Frank A, Emmett N, Turnbull DM, Birch-Machin MA, Reynolds NJ. The anti-psoriatic drug anthralin accumulates in keratinocyte mitochondria, dissipates mitochondrial membrane potential, and induces apoptosis through a pathway dependent on respiratory competent mitochondria. FASEB J. 2005 Jun;19(8):1012-4. doi: 10.1096/fj.04-2664fje. Epub 2005 Mar 31.

  PMID: 15802490 BACKGROUND

• Mendonca CO, Burden AD. Current concepts in psoriasis and its treatment. Pharmacol Ther. 2003 Aug;99(2):133-47. doi: 10.1016/s0163-7258(03)00041-x.

  PMID: 12888109 BACKGROUND

• Sehgal VN, Verma P, Khurana A. Anthralin/dithranol in dermatology. Int J Dermatol. 2014 Oct;53(10):e449-60. doi: 10.1111/j.1365-4632.2012.05611.x. Epub 2014 Sep 10.

  PMID: 25208745 BACKGROUND

• Agarwal R, Katare OP, Vyas SP. Preparation and in vitro evaluation of liposomal/niosomal delivery systems for antipsoriatic drug dithranol. Int J Pharm. 2001 Oct 9;228(1-2):43-52. doi: 10.1016/s0378-5173(01)00810-9.

  PMID: 11576767 BACKGROUND

• Pradhan M, Singh D, Singh MR. Novel colloidal carriers for psoriasis: current issues, mechanistic insight and novel delivery approaches. J Control Release. 2013 Sep 28;170(3):380-95. doi: 10.1016/j.jconrel.2013.05.020. Epub 2013 Jun 13.

  PMID: 23770117 BACKGROUND

• Dubey V, Mishra D, Dutta T, Nahar M, Saraf DK, Jain NK. Dermal and transdermal delivery of an anti-psoriatic agent via ethanolic liposomes. J Control Release. 2007 Nov 6;123(2):148-54. doi: 10.1016/j.jconrel.2007.08.005. Epub 2007 Aug 16.

  PMID: 17884226 BACKGROUND

• Touitou E, Dayan N, Bergelson L, Godin B, Eliaz M. Ethosomes - novel vesicular carriers for enhanced delivery: characterization and skin penetration properties. J Control Release. 2000 Apr 3;65(3):403-18. doi: 10.1016/s0168-3659(99)00222-9.

  PMID: 10699298 BACKGROUND

• Fathalla D, Youssef EMK, Soliman GM. Liposomal and Ethosomal Gels for the Topical Delivery of Anthralin: Preparation, Comparative Evaluation and Clinical Assessment in Psoriatic Patients. Pharmaceutics. 2020 May 11;12(5):446. doi: 10.3390/pharmaceutics12050446.

  PMID: 32403379 DERIVED

Related Links

• Nanotechnology in dermatology

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: The aim of the present study was to develop an ethosomal delivery system anthralin and evaluate its effectiveness and safety in treatment of psoriasis and comparing it with liposomal delivery system anthralin.

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 21, 2017
• Study Start: November 30, 2017
• Primary Completion: December 30, 2019
• Study Completion: January 15, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

EG (1)