Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03942250

Enrollment

Registered

2019-05-08

Start date

2017-01-31

Completion date

2019-02-28

Last updated

2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Skin Ulcer, Epidermolysis Bullosa

Keywords

Epidermolysis Bullosa, Amniotic membrane

Brief summary

To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients.

Detailed description

Dried human amniotic membrane dressing were obtained from National center for radiation research and technology, Egypt (NCRRT), under commercial name REGE pro.

Interventions

BIOLOGICALREGE pro dressing

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1- Patients diagnosed as EB wounds must be chronic

Exclusion criteria

1. Patients Must stop other line of treatment 2. Exclude patients have: 1. Autoimmune diseases 2. Diabetes

Design outcomes

Primary

Measure	Time frame	Description
Lesion area	6 weeks	The lesion area from the first treatment is greater than 2 cm\^2 (grade 3, according to CTCAE v4.0), to the complete healing (= 0 cm\^2).
Clinical progression sings	6 weeks	* After the first application time: White transperent color of granulation tissue appeared. * After the second application time: color dense of granulation tissue increased and covered all over the wound. * After the third application time: granulation tissue thickness increased and appeared as a complete homogenous layer. * After the fourth application time: depending on lesion depth and size, granulation tissue turned to be pink to red color. * After the fifth and sexth application time: Skin layers development appeared.

Secondary

Measure	Time frame	Description
Patient complain (upon the weekly questionnaire)	6 weeks	The quality of life is scored 0 (minimum) -100 (maximum), the pain reduction is scored 0-100 (as previous) from the first visit till 6 weeks.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026