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

Sponsor
Egyptian Atomic Energy Authority (Other)
Overall Status
Completed
CT.gov ID
NCT03440541
Collaborator
(none)
22
Enrollment
1
Location
1
Arm
8.1
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Combination Product: REGE pro
 N/A

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

Study Type:
Interventional
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 :
Aug 4, 2015
Actual Primary Completion Date :
Feb 13, 2016
Actual Study Completion Date :
Apr 8, 2016

Arms and Interventions

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

Primary Outcome Measures

  1. Scaling size decrement [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 [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 [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

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • patients have psoriasis lesion
Exclusion Criteria:
  • must stop other line of treatment

Contacts and Locations

Locations

Site City State Country Postal Code
1 Amniotic tissue lab Cairo Egypt 29

Sponsors and Collaborators

  • Egyptian Atomic Energy Authority

Investigators

  • Study Director: Nashwa K Radwan, PhD, NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nashwa Radwan, Director, Egyptian Atomic Energy Authority
ClinicalTrials.gov Identifier:
NCT03440541
Other Study ID Numbers:
  • 4102017NCRRT
First Posted:
Feb 22, 2018
Last Update Posted:
Jun 27, 2019
Last Verified:
Jun 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nashwa Radwan, Director, Egyptian Atomic Energy Authority
Amniotic membrane
Psoriasis
Treatment
Additional relevant MeSH terms:
Psoriasis

Study Results

No Results Posted as of Jun 27, 2019