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Completed

NCT Number: NCT03440541

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

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

Completed

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Key information

Conditions

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

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amniotic tissue lab

Cairo, 29, Egypt

About this study

Human amniotic membrane extra-cellular matrix was purchased from National center for radiation research and technology, Egypt, under commercial name REGE pro gel.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients have psoriasis lesion

Exclusion criteria

  • must stop other line of treatment

Treatment and study plan

REGE pro

Combination Product

REGE pro is a patch of human amniotic membrane sterilized by gamma radiation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Egyptian Atomic Energy Authority

Other Gov

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 22, 2018
Registry last updated
Jun 27, 2019

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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