Epidermolysis BullosaNCT03942250
Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients
A study testing REGE pro dressing in people with Epidermolysis Bullosa and Chronic Skin Ulcer, run by Egyptian Atomic Energy Authority at 1 site in Egypt.
Trial summary
To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients. Read more about this study
- Who is it for?
- Ages 12 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Epidermolysis Bullosa, Chronic Skin Ulcer
- What is being tested?
- REGE pro dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1- Patients diagnosed as EB wounds must be chronic
Who cannot join
- Patients Must stop other line of treatment
- Exclude patients have:
- Autoimmune diseases
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients.
Read the detailed description
Dried human amniotic membrane dressing were obtained from National center for radiation research and technology, Egypt (NCRRT), under commercial name REGE pro.
- Conditions
- Epidermolysis Bullosa, Chronic Skin Ulcer
- Being tested
- REGE pro dressing
- Keywords
- Epidermolysis Bullosa, Amniotic membrane
- Medical subject headings
- Epidermolysis Bullosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGE pro dressingBiological
REGE pro is a dressing of dried human amniotic membrane sterilized by gamma radiation
| Study group | Role | What they receive |
|---|---|---|
| Treated | Experimental | Patients who received REGE pro dressing on EB wounds lesion weekly for 10 weeks Receives: Biological: REGE pro dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study startJan 2017
- Primary completionDec 2017
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epidermolysis BullosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Atomic Energy Authority
- Sponsor type
- Other government
- Collaborators
- Waleed Nemr,Egyptian Atomic Energy Authority
- Responsible party
- Principal investigator, Nashwa Radwan, Egyptian Atomic Energy Authority
- Investigators
- Nashwa K Radwan, PhD, Study director, NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942250
- Sponsor's protocol ID
- 2222018NCRRT
- Status last verified
- Sep 2023
- First submitted
- 22 Feb 2018
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nemr W, Bashandy AS, Araby E, Khamiss O. Biological Activity Alterations of Human Amniotic Membrane Pre and Post Irradiation Tissue Banking. Pak J Biol Sci. 2016;19(7):289-298. doi: 10.3923/pjbs.2016.289.298.
PubMed 29023030Lo V, Lara-Corrales I, Stuparich A, Pope E. Amniotic membrane grafting in patients with epidermolysis bullosa with chronic wounds. J Am Acad Dermatol. 2010 Jun;62(6):1038-44. doi: 10.1016/j.jaad.2009.02.048.
PubMed 20466177
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients
- ClinicalTrials.gov ID
- NCT03942250
- Acronym / sponsor ID
- 2222018NCRRT
- Conditions
- Epidermolysis Bullosa, Chronic Skin Ulcer
- Keywords
- Epidermolysis Bullosa, Amniotic membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Egyptian Atomic Energy AuthorityOther government
- Collaborators
- Waleed Nemr,Egyptian Atomic Energy Authority
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated | Experimental | Biological: REGE pro dressingPatients who received REGE pro dressing on EB wounds lesion weekly for 10 weeks |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1- Patients diagnosed as EB wounds must be chronic
Key exclusion criteria (4 listed)
- Patients Must stop other line of treatment
- Exclude patients have:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGE pro dressingREGE pro is a dressing of dried human amniotic membrane sterilized by gamma radiation | Biological | Treated |
Primary outcome
Lesion area
Time frame: 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
Time frame: 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.
1 secondary outcome
Patient complain (upon the weekly questionnaire)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 29023030Nemr W, Bashandy AS, Araby E, Khamiss O. Biological Activity Alterations of Human Amniotic Membrane Pre and Post Irradiation Tissue Banking. Pak J Biol Sci. 2016;19(7):289-298. doi: 10.3923/pjbs.2016.289.298.
- Results publication: PubMed 20466177Lo V, Lara-Corrales I, Stuparich A, Pope E. Amniotic membrane grafting in patients with epidermolysis bullosa with chronic wounds. J Am Acad Dermatol. 2010 Jun;62(6):1038-44. doi: 10.1016/j.jaad.2009.02.048.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nashwa K Radwan, PhD study director
NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REGE pro dressing in people with Epidermolysis Bullosa and Chronic Skin Ulcer, run by Egyptian Atomic Energy Authority at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion area (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03942250, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.