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

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ClinicalTrials.gov Identifier: NCT03348462
Recruitment Status : Active, not recruiting
First Posted : November 21, 2017
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Eman Kamal, Assiut University

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.


Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: ethosomal preparation of anthralin Drug: liposomal preparation of anthralin Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Formulation and Clinical Evaluation of Ethosomal and Liposomal Preparations of Anthralin in Psoriasis
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : January 25, 2019
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Anthralin

Arm Intervention/treatment
Experimental: ethosomal anthralin
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
once daily with short contact topical application

Active Comparator: liposomal anthralin
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
once daily with short contact topical application




Primary Outcome Measures :
  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

    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.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   9 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03348462


Locations
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Egypt
Assiut University Hospital
Assiut, Egypt, 71526
Sponsors and Collaborators
Assiut University

Additional Information:
Publications:

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Responsible Party: Eman Kamal, Principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03348462     History of Changes
Other Study ID Numbers: faceoealpoaip
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eman Kamal, Assiut University:
psoriasis
anthralin
ethosome
liposome
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Anthralin
Dermatologic Agents