Back to resultsUses of Gamma Irradiated Amniotic Membrane as an Alternative Method in Psoriasis Treatment
Primary Purpose
Psoriasis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
REGE pro
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Amniotic membrane, Psoriasis, Treatment
Eligibility Criteria
Inclusion Criteria:
- patients have psoriasis lesion
Exclusion Criteria:
- must stop other line of treatment
Sites / Locations
- Amniotic tissue lab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treated
Arm Description
Patients who received patches of REGE pro on psoriasis lesion weekly for 8 weeks
Outcomes
Primary Outcome Measures
Scaling size decrement
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
Histopathological improvement
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
Erythema disappearing
REGE pro gel gradually decreased erythema in patients within 4-6 weeks, these data were collected from applied patients by questionnaire.
Full Information
NCT ID
NCT03440541
First Posted
November 29, 2017
Last Updated
June 26, 2019
Sponsor
Egyptian Atomic Energy Authority
1. Study Identification
Unique Protocol Identification Number
NCT03440541
Brief Title
Uses of Gamma Irradiated Amniotic Membrane as an Alternative Method in Psoriasis Treatment
Official Title
Uses of Gamma Irradiated Amniotic Membrane as an Alternative Method in Psoriasis Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 4, 2015 (Actual)
Primary Completion Date
February 13, 2016 (Actual)
Study Completion Date
April 8, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Egyptian Atomic Energy Authority
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Using of human amniotic membrane extra-cellular matrix as a topical treatment for improving Psoriasis Area and Severity Index (PASI).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Amniotic membrane, Psoriasis, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treated
Arm Type
Experimental
Arm Description
Patients who received patches of REGE pro on psoriasis lesion weekly for 8 weeks
Intervention Type
Combination Product
Intervention Name(s)
REGE pro
Intervention Description
REGE pro is a patch of human amniotic membrane sterilized by gamma radiation
Primary Outcome Measure Information:
Title
Scaling size decrement
Description
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
Time Frame
2 weeks
Title
Histopathological improvement
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Erythema disappearing
Description
REGE pro gel gradually decreased erythema in patients within 4-6 weeks, these data were collected from applied patients by questionnaire.
Time Frame
4-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients have psoriasis lesion
Exclusion Criteria:
must stop other line of treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nashwa K Radwan, PhD
Organizational Affiliation
NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY
Official's Role
Study Director
Facility Information:
Facility Name
Amniotic tissue lab
City
Cairo
ZIP/Postal Code
29
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
26306147
Citation
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Uses of Gamma Irradiated Amniotic Membrane as an Alternative Method in Psoriasis Treatment
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