Autoimmune Blistering Disease, Pemphigus Vulgaris, Skin Erosion
Conditions
Keywords
pemphigus vulgaris, topical insulin, wound healing, Insulin Glargine, Regular Insulin, Autoimmune Blistering Disease, Erosions
Brief summary
This study investigates the efficacy of topical insulin in promoting healing of pemphigus vulgaris erosions. Twenty patients with pemphigus vulgaris were enrolled, each contributing three comparable lesions randomly allocated to receive long-acting insulin (insulin glargine), short-acting insulin (regular insulin), or normal saline control. Treatments were applied topically twice daily for 14 days or until complete healing.
Interventions
DRUGinsulin glargine
Topical application of insulin glargine (100 IU/mL) at dose of 0.1 mL per 10 cm² lesion area, applied twice daily using insulin syringe spray technique for 14 days or until complete healing
DRUGhuman insulin
topical application of regular insulin (100 IU/mL) at dose of 0.1 mL per 10 cm² lesion area, applied twice daily using insulin syringe spray technique for 14 days or until complete healing
DRUG0.9% Normal Saline
Topical application of 0.9% normal saline at dose of 0.1 mL per 10 cm² lesion area, applied twice daily using insulin syringe spray technique for 14 days or until complete healing
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Three-arm, parallel-group, randomized controlled trial Within-patient comparison design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of pemphigus vulgaris by clinical and histopathological criteria * Presence of erosions and/or ulcers on skin and/or mucous membranes * At least three lesions of comparable location, size, depth, and healing stage
Exclusion criteria
* Lesions with clinical signs of secondary infection (purulence, surrounding erythema, fever) * Uncontrolled general condition significantly affecting wound healing (e.g., hypoalbuminemia) * Known allergy to insulin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Healing | Up to 14 days | Number of days required for complete epithelialization of the lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Surface Area Reduction | Baseline, Day 7, Day 14 | Percentage reduction in lesion surface area from baseline,Measured using ImageJ software from standardized photographs |
| Daily Healing Rate | 14 days | Percentage of healing per day,Calculated as percentage of surface area reduction per day |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORTarek M Hussein, MB BCh, MD
University of Alexandria
PRINCIPAL_INVESTIGATORCarmen I Farid, MB BCh, MD
University of Alexandria
Outcome results
None listed