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Completed

NCT Number: NCT03348462

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

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.

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Key information

Conditions

Psoriasis Vulgaris Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

9 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assiut University Hospital

Asyut, 71526, Egypt

About this study

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.Anthralin mechanism of action involves inhibition of the proliferation of keratinocytes. Further, accumulation of anthralin inside the mitochondria impairs energy supply to the cell, probably due to the free radicals resulting from oxidation of the drug. Anthralin also interferes with the replication of DNA and slows down the extreme cell division that occurs in psoriatic plaques. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with mild to moderate, stable chronic plaque psoriasis.

Exclusion criteria

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

Treatment and study plan

ethosomal preparation of anthralin

Drug

once daily with short contact topical application

liposomal preparation of anthralin

Drug

once daily with short contact topical application

Primary outcomes

  1. Psoriasis Area and Severity Index (PASI) score

    Time frame: up to 8 weeks

    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

    • Divide body into four areas: head, arms, trunk, and legs .
    • 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).
    • Sum scores of erythema, thickness, and scale for each area.
    • 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%).

    • 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.
    • Add these scores to get the PASI score.

Secondary outcomes

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

    Time frame: up to 8 weeks

    hematoxylin and eosin staining of skin biopsies from psoriatic lesions before and after treatment will be done.

  2. Safety of the drug perparations

    Time frame: up to 8 weeks

    by recording any possible adverse events like itching, burning sensation, staining of skin or clothes and erythema.

  3. Patient satisfaction

    Time frame: up to 8 weeks

    at the end of treatment, it will be evaluated by patient's self assessment of the degree of improvement of psoriasis

  4. digital photography

    Time frame: up to 8 weeks

    digital photography of the lesions before and after treatment using a 14.1 megapixels Sony DSC- W 390 digital camera will be done for each patient to assess any changes in clinical appearance of psoriatic lesions and evaluate the response of treatment.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 21, 2017
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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