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OpenTrials
Completed

NCT Number: NCT07461103

Effect of Topical Insulin on Healing Rate of Pemphigus Lesions

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.

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Key information

Conditions

Pemphigus Vulgaris Autoimmune Blistering Disease Autoimmune Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pemphigus Skin Diseases Skin Diseases, Vesiculobullous Skin Erosion Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alexandria main university hospital, Department of Dermatology and Venereology

Alexandria, 22301, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin glargine

Drug

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

Other names: lantus

human insulin

Drug

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

Other names: actrapid

0.9% normal saline

Drug

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

Other names: control, placebo

Primary outcomes

  1. Time to Complete Healing

    Time frame: Up to 14 days

    Number of days required for complete epithelialization of the lesion

Secondary outcomes

  1. Lesion Surface Area Reduction

    Time frame: Baseline, Day 7, Day 14

    Percentage reduction in lesion surface area from baseline,Measured using ImageJ software from standardized photographs

  2. Daily Healing Rate

    Time frame: 14 days

    Percentage of healing per day,Calculated as percentage of surface area reduction per day

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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