An interventional study of REGE pro dressing in Epidermolysis Bullosa and Chronic Skin Ulcer, sponsored by Egyptian Atomic Energy Authority. Completed at 1 site in Egypt. Open to participants aged 12 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Egyptian Atomic Energy Authority · Not applicable, Interventional, and Treatment
To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients.
Dried human amniotic membrane dressing were obtained from National center for radiation research and technology, Egypt (NCRRT), under commercial name REGE pro.
85 studies on the registry are indexed under Epidermolysis Bullosa; 17 are open to participants now.
This study's enrollment of 8 is below the median of 14 across 67 interventional studies indexed under Epidermolysis Bullosa.
Browse Epidermolysis Bullosa studies →Egyptian Atomic Energy Authority is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1- Patients diagnosed as EB wounds must be chronic
Exclusion Criteria:
Exclude patients have:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who received REGE pro dressing on EB wounds lesion weekly for 10 weeks
Biological: REGE pro dressing
REGE pro is a dressing of dried human amniotic membrane sterilized by gamma radiation
Lesion area
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).
Time frame: 6 weeks
Clinical progression sings
* 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.
Time frame: 6 weeks
Patient complain (upon the weekly questionnaire)
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.
Time frame: 6 weeks
Ran from Jan 2017 to primary completion in Dec 2017, 11 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Egyptian Atomic Energy Authority