Epidermolysis Bullosa (EB)EB-INS-AFGNCT07907523
Topical Insulin Versus Irradiated Amniotic Fluid Gel for Wound Healing in Epidermolysis Bullosa
A study testing Topical Insulin (Actrapid®), Topical Irradiated Amniotic Fluid Gel and No active study treatment in people with Epidermolysis Bullosa (EB) and Chronic Wounds, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate and compare the safety and efficacy of topical insulin and topical irradiated amniotic fluid gel in promoting wound healing in patients with epidermolysis bullosa (EB). Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Epidermolysis Bullosa (EB), Chronic Wounds, Wound Healing
- What is being tested?
- Topical Insulin (Actrapid®), Topical Irradiated Amniotic Fluid Gel and No active study treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jan 2026
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed diagnosis of epidermolysis bullosa (EB) of any type. Presence of fresh, non-infected wounds suitable for topical treatment. Wound surface area up to 3 × 5 cm²
Who cannot join
- Presence of clinically infected wounds. Wounds with a surface area greater than 3 × 5 cm². Poor compliance or inability to adhere to the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Safety and Efficacy of Topical Insulin Versus Topical Irradiated Amniotic Fluid Gel for Treatment of Epidermolysis Bullosa Patients
This study aims to evaluate and compare the safety and efficacy of topical insulin and topical irradiated amniotic fluid gel in promoting wound healing in patients with epidermolysis bullosa (EB). Thirty patients with confirmed EB and suitable non-infected wounds were recruited from the Dermatology and Venereology Department, Tanta University Hospitals, Egypt. Wounds were assessed before and after treatment using wound surface area measurements, pain scores, clinical evaluation, and photographic documentation. Treatment was administered weekly for four consecutive weeks, with subsequent follow-up assessments. An untreated wound group served as the control. The study also evaluated patient satisfaction and treatment-related adverse effects.
Read the detailed description
Epidermolysis bullosa (EB) is a group of inherited disorders characterized by skin fragility and recurrent blistering and erosions following minor trauma. Wound management in patients with EB can be challenging because of impaired wound healing, pain, and the risk of infection. This study was conducted to compare the safety and efficacy of topical insulin and topical irradiated amniotic fluid gel for wound healing in patients with EB.
The study included 30 patients with a confirmed diagnosis of EB who attended the outpatient clinic of the Dermatology and Venereology Department at Tanta University Hospitals, Egypt, between January 2025 and January 2026. Eligible patients had fresh, non-infected wounds suitable for topical treatment, with wound dimensions not exceeding 3 × 5 cm². Patients with clinically infected wounds, larger wounds, or inability to comply with the study protocol were excluded.
The study used a comparative, multi-arm design with three wound-treatment groups:
Group A: Topical insulin (Actrapid®, rapid-acting human insulin 100 IU/mL), administered at 1 mL per session.
Group B: Topical irradiated amniotic fluid gel, administered at 1 mL per session.
Group C: Untreated control wounds.
Treatment sessions were conducted weekly for four consecutive weeks. Assessments were performed at baseline, after treatment, and during follow-up. The study evaluated wound surface area, pain using the Wong-Baker pain scale, clinical improvement using the Global Aesthetic Improvement Scale, patient satisfaction, and adverse effects. Standardized digital photographs were also obtained to document changes in wound appearance. Disease activity and severity were assessed using the Epidermolysis Bullosa Disease Activity and Scarring Index.
The primary purpose was to compare wound-healing outcomes between topical insulin, topical irradiated amniotic fluid gel, and untreated control wounds. The study also assessed treatment tolerability and safety by monitoring adverse effects throughout treatment and follow-up.
The study received approval from the Research Ethics Committee, Faculty of Medicine, Tanta University, Egypt (approval number 36264MS778/12/24).
- Conditions
- Epidermolysis Bullosa (EB), Chronic Wounds, Wound Healing
- Being tested
- Topical Insulin (Actrapid®), Topical Irradiated Amniotic Fluid Gel, No active study treatment
- Keywords
- Epidermolysis bullosa, Topical insulin, Irradiated amniotic fluid gel, Wound healing
- Medical subject headings
- Epidermolysis Bullosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Insulin (Actrapid®)Drug
Rapid-acting human insulin (100 IU/mL), with 1 mL applied directly to the wound surface during each session. The wound was covered with Vaseline gauze and secured with a gauze wrap. Treatment was administered weekly for four consecutive weeks.
Topical Irradiated Amniotic Fluid GelBiological
Irradiated amniotic fluid gel manufactured by the Egyptian Atomic Energy Authority. A volume of 1 mL was applied directly to the wound surface during each session, followed by coverage with Vaseline gauze and a gauze wrap. Treatment was administered weekly for four consecutive weeks.
No active study treatmentOther
No active study product was applied. Wounds were covered with Vaseline gauze and secured with a gauze wrap.
| Study group | Role | What they receive |
|---|---|---|
| Topical insulin | Experimental | Wounds in this group received topical insulin to evaluate its safety and efficacy in promoting wound healing in patients with epidermolysis bullosa. Receives: Drug: Topical Insulin (Actrapid®) |
| Topical Irradiated Amniotic Fluid Gel | Experimental | Wounds in this group received topical irradiated amniotic fluid gel to evaluate its safety and efficacy in promoting wound healing in patients with epidermolysis bullosa. Receives: Biological: Topical Irradiated Amniotic Fluid Gel |
| Untreated Control | Other | Wounds in this group received no active study treatment and served as controls for comparison with the topical insulin and irradiated amniotic fluid gel groups. Wounds were covered with Vaseline gauze and secured with a gauze wrap. Receives: Other: No active study treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound surface area
Change in wound surface area (cm²) from baseline to after treatment and at one-month follow-up, comparing wounds treated with topical insulin, topical irradiated amniotic fluid gel, and untreated control wounds.
Measured: Baseline, one week after the last treatment session (after four weekly sessions), and one-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jan 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis Bullosa (EB)Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesrin Sabry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907523
- Sponsor's protocol ID
- 36264MS778/12/24
- Acronym
- EB-INS-AFG
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Safety and Efficacy of Topical Insulin Versus Topical Irradiated Amniotic Fluid Gel for Treatment of Epidermolysis Bullosa Patients
- ClinicalTrials.gov ID
- NCT07907523
- Acronym / sponsor ID
- EB-INS-AFG / 36264MS778/12/24
- Conditions
- Epidermolysis Bullosa (EB), Chronic Wounds, Wound Healing
- Keywords
- Epidermolysis bullosa, Topical insulin, Irradiated amniotic fluid gel, Wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 30 Oct 2026 (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.
This study aims to evaluate and compare the safety and efficacy of topical insulin and topical irradiated amniotic fluid gel in promoting wound healing in patients with epidermolysis bullosa (EB). Thirty patients with confirmed EB and suitable non-infected wounds were recruited from the Dermatology and Venereology Department, Tanta University Hospitals, Egypt. Wounds were assessed before and after treatment using wound surface area measurements, pain scores, clinical evaluation, and photographic documentation. Treatment was administered weekly for four consecutive weeks, with subsequent follow-up assessments. An untreated wound group served as the control. The study also evaluated patient satisfaction and treatment-related adverse effects.
Detailed description
Epidermolysis bullosa (EB) is a group of inherited disorders characterized by skin fragility and recurrent blistering and erosions following minor trauma. Wound management in patients with EB can be challenging because of impaired wound healing, pain, and the risk of infection. This study was conducted to compare the safety and efficacy of topical insulin and topical irradiated amniotic fluid gel for wound healing in patients with EB.
The study included 30 patients with a confirmed diagnosis of EB who attended the outpatient clinic of the Dermatology and Venereology Department at Tanta University Hospitals, Egypt, between January 2025 and January 2026. Eligible patients had fresh, non-infected wounds suitable for topical treatment, with wound dimensions not exceeding 3 × 5 cm². Patients with clinically infected wounds, larger wounds, or inability to comply with the study protocol were excluded.
The study used a comparative, multi-arm design with three wound-treatment groups:
Group A: Topical insulin (Actrapid®, rapid-acting human insulin 100 IU/mL), administered at 1 mL per session.
Group B: Topical irradiated amniotic fluid gel, administered at 1 mL per session.
Group C: Untreated control wounds.
Treatment sessions were conducted weekly for four consecutive weeks. Assessments were performed at baseline, after treatment, and during follow-up. The study evaluated wound surface area, pain using the Wong-Baker pain scale, clinical improvement using the Global Aesthetic Improvement Scale, patient satisfaction, and adverse effects. Standardized digital photographs were also obtained to document changes in wound appearance. Disease activity and severity were assessed using the Epidermolysis Bullosa Disease Activity and Scarring Index.
The primary purpose was to compare wound-healing outcomes between topical insulin, topical irradiated amniotic fluid gel, and untreated control wounds. The study also assessed treatment tolerability and safety by monitoring adverse effects throughout treatment and follow-up.
The study received approval from the Research Ethics Committee, Faculty of Medicine, Tanta University, Egypt (approval number 36264MS778/12/24).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical insulin | Experimental | Drug: Topical Insulin (Actrapid®)Wounds in this group received topical insulin to evaluate its safety and efficacy in promoting wound healing in patients with epidermolysis bullosa. |
| Topical Irradiated Amniotic Fluid Gel | Experimental | Biological: Topical Irradiated Amniotic Fluid GelWounds in this group received topical irradiated amniotic fluid gel to evaluate its safety and efficacy in promoting wound healing in patients with epidermolysis bullosa. |
| Untreated Control | Other | Other: No active study treatmentWounds in this group received no active study treatment and served as controls for comparison with the topical insulin and irradiated amniotic fluid gel groups. Wounds were covered with Vaseline gauze and secured with a gauze wrap. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of epidermolysis bullosa (EB) of any type. Presence of fresh, non-infected wounds suitable for topical treatment. Wound surface area up to 3 × 5 cm²
Key exclusion criteria (1 listed)
- Presence of clinically infected wounds. Wounds with a surface area greater than 3 × 5 cm². Poor compliance or inability to adhere to the study protocol.
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 |
|---|---|---|
| Topical Insulin (Actrapid®)Rapid-acting human insulin (100 IU/mL), with 1 mL applied directly to the wound surface during each session. The wound was covered with Vaseline gauze and secured with a gauze wrap. Treatment was administered weekly for four consecutive weeks. | Drug | Topical insulin |
| Topical Irradiated Amniotic Fluid GelIrradiated amniotic fluid gel manufactured by the Egyptian Atomic Energy Authority. A volume of 1 mL was applied directly to the wound surface during each session, followed by coverage with Vaseline gauze and a gauze wrap. Treatment was administered weekly for four consecutive weeks. | Biological | Topical Irradiated Amniotic Fluid Gel |
| No active study treatmentNo active study product was applied. Wounds were covered with Vaseline gauze and secured with a gauze wrap. | Other | Untreated Control |
Primary outcome
Change in wound surface area
Time frame: Baseline, one week after the last treatment session (after four weekly sessions), and one-month follow-up.
Change in wound surface area (cm²) from baseline to after treatment and at one-month follow-up, comparing wounds treated with topical insulin, topical irradiated amniotic fluid gel, and untreated control wounds.
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 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Epidermolysis Bullosa (EB)
RecruitingPhase 2
A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study
Epidermolysis Bullosa (EB), Dystrophic Epidermolysis Bullosa
RecruitingPhase 3
Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
Epidermolysis Bullosa (EB)
RecruitingPhase 2
A Study to Evaluate ENERGI-F703EB Cream in Epidermolysis Bullosa
Epidermolysis Bullosa (EB), Junctional Epidermolysis Bullosa
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Not yet recruitingPhase 3
An Open Label Extension Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
Epidermolysis Bullosa (EB)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Insulin (Actrapid®), Topical Irradiated Amniotic Fluid Gel and No active study treatment in people with Epidermolysis Bullosa (EB) and Chronic Wounds, run by Tanta University 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 1 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 30 Oct 2026. 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?
Change in wound surface area (time frame: Baseline, one week after the last treatment session (after four weekly sessions), and one-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.