An interventional study of Topical Insulin (Actrapid®) and Topical Irradiated Amniotic Fluid Gel in Epidermolysis Bullosa (EB), Chronic Wounds and Wound Healing, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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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.
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).
85 studies on the registry are indexed under Epidermolysis Bullosa; 17 are open to participants now.
This study's enrollment of 30 is above the median of 14 across 67 interventional studies indexed under Epidermolysis Bullosa.
Browse Epidermolysis Bullosa studies →Tanta University is the lead sponsor of 1,013 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
Exclusion Criteria:
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.
Wounds in this group received topical insulin to evaluate its safety and efficacy in promoting wound healing in patients with epidermolysis bullosa.
Drug: Topical Insulin (Actrapid®)
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.
Biological: Topical Irradiated Amniotic Fluid Gel
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.
Other: No active study treatment
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.
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 product was applied. Wounds were covered with Vaseline gauze and secured with a gauze wrap.
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.
Time frame: Baseline, one week after the last treatment session (after four weekly sessions), and one-month follow-up.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2025 to primary completion in Jan 2026, 12 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Insulin, Regular, Human