Effect of Topical Insulin on Healing Rate of Pemphigus Lesions

NCT07461103 | Completed Phase 2

• 1 other identifier: 0108172
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pemphigus Vulgaris; Skin Erosion; Autoimmune Blistering Disease

Keywords

pemphigus vulgaris; topical insulin; wound healing; Insulin Glargine; Regular Insulin; Autoimmune Blistering Disease; Erosions

Outcome Measures

Primary Outcomes (1)

• Time to Complete Healing

  Number of days required for complete epithelialization of the lesion

  Up to 14 days

Secondary Outcomes (2)

• Lesion Surface Area Reduction

  Baseline, Day 7, Day 14

• Daily Healing Rate

  14 days

Study Arms (3)

Long-acting insulin (LA)

EXPERIMENTAL

Lesions treated with topical insulin glargine (Lantus) 0.1 mL per 10 cm² twice daily

Drug: insulin glargine

Regular human insulin (SA)

EXPERIMENTAL

Lesions treated with topical regular insulin (Actrapid) 0.1 mL per 10 cm² twice daily

Drug: human insulin

control

PLACEBO COMPARATOR

Lesions treated with topical 0.9% normal saline 0.1 mL per 10 cm² twice daily

Drug: 0.9% Normal Saline

Interventions

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

Also known as: lantus

Long-acting insulin (LA)

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

Also known as: actrapid

Regular human insulin (SA)

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

Also known as: control, placebo

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria main university hospital, Department of Dermatology and Venereology

Alexandria, 22301, Egypt

Location

MeSH Terms

Conditions

Pemphigus; Insulin Resistance

Interventions

Insulin Glargine; Insulin; Saline Solution

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Tarek M Hussein, MB BCh, MD

  University of Alexandria

  PRINCIPAL INVESTIGATOR

• Carmen I Farid, MB BCh, MD

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-arm, parallel-group, randomized controlled trial Within-patient comparison design

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: June 22, 2024
• Primary Completion: August 10, 2025
• Study Completion: August 10, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)