Effect of Topical Insulin on Healing Rate of Pemphigus Lesions
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Time to Complete Healing
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Long-acting insulin (LA)
Lesions treated with topical insulin glargine (Lantus) 0.1 mL per 10 cm² twice daily
Intervention: insulin glargine (Drug)
Regular human insulin (SA)
Lesions treated with topical regular insulin (Actrapid) 0.1 mL per 10 cm² twice daily
Intervention: human insulin (Drug)
control
Lesions treated with topical 0.9% normal saline 0.1 mL per 10 cm² twice daily
Intervention: 0.9% Normal Saline (Drug)
Outcomes
Primary Outcomes
Time to Complete Healing
Time Frame: Up to 14 days
Number of days required for complete epithelialization of the lesion
Secondary Outcomes
- Lesion Surface Area Reduction(Baseline, Day 7, Day 14)
- Daily Healing Rate(14 days)