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Uses of Gamma Irradiated Amniotic Membrane as an Alternative Method in Psoriasis Treatment

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03440541
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Nashwa Radwan, Egyptian Atomic Energy Authority

Study Description
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Brief Summary:
Using of human amniotic membrane extra-cellular matrix as a topical treatment for improving Psoriasis Area and Severity Index (PASI).

Condition or disease Intervention/treatment Phase
Psoriasis Combination Product: REGE pro Not Applicable

Detailed Description:
Human amniotic membrane extra-cellular matrix was purchased from National center for radiation research and technology, Egypt, under commercial name REGE pro gel.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uses of Gamma Irradiated Amniotic Membrane as an Alternative Method in Psoriasis Treatment
Actual Study Start Date : August 4, 2015
Actual Primary Completion Date : February 13, 2016
Actual Study Completion Date : April 8, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: treated
Patients who received patches of REGE pro on psoriasis lesion weekly for 8 weeks
 Combination Product: REGE pro
REGE pro is a patch of human amniotic membrane sterilized by gamma radiation


Outcome Measures
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Primary Outcome Measures :
  1. Scaling size decrement [ Time Frame: 2 weeks ]
    REGE pro gel decreased scaling size in patients with sever scales to moderate scale within two weeks, scaling size decrement from moderate to mild within two weeks, and from mild to complete curing within two weeks

  2. Histopathological improvement [ Time Frame: 6 weeks ]
    Two biopsies were taken from each patient before and at the end of the treatment. It was noted that all histological signs as munro's microabscess and the elongation of rete ridges were absent.


Secondary Outcome Measures :
  1. Erythema disappearing [ Time Frame: 4-6 weeks ]
    REGE pro gel gradually decreased erythema in patients within 4-6 weeks, these data were collected from applied patients by questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients have psoriasis lesion

Exclusion Criteria:

  • must stop other line of treatment
Contacts and Locations
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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): NCT03440541


Locations
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Egypt
Amniotic tissue lab
Cairo, Egypt, 29
Sponsors and Collaborators
Egyptian Atomic Energy Authority
Investigators
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Study Director: Nashwa K Radwan, PhD NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY
More Information
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Publications:

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Responsible Party: Nashwa Radwan, Director, Egyptian Atomic Energy Authority
ClinicalTrials.gov Identifier: NCT03440541    
Other Study ID Numbers: 4102017NCRRT
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 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 Nashwa Radwan, Egyptian Atomic Energy Authority:
Amniotic membrane
Psoriasis
Treatment
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases