Effect of Topical Insulin on Healing Rate of Pemphigus Lesions

March 5, 2026 updated by: Alexandria University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 22301
        • Alexandria main university hospital, Department of Dermatology and Venereology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long-acting insulin (LA)
Lesions treated with topical insulin glargine (Lantus) 0.1 mL per 10 cm² twice daily
Drug: insulin 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
Other Names:
  • lantus
Experimental: Regular human insulin (SA)
Lesions treated with topical regular insulin (Actrapid) 0.1 mL per 10 cm² twice daily
Drug: human 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
Other Names:
  • actrapid
Placebo Comparator: control
Lesions treated with topical 0.9% normal saline 0.1 mL per 10 cm² twice daily
Drug: 0.9% 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
Other Names:
  • control, placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Complete Healing
Time Frame: Up to 14 days
Number of days required for complete epithelialization of the lesion
Up to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Day 7, Day 14
Daily Healing Rate
Time Frame: 14 days
Percentage of healing per day,Calculated as percentage of surface area reduction per day
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Tarek M Hussein, MB BCh, MD, University of Alexandria
  • Principal Investigator: Carmen I Farid, MB BCh, MD, University of Alexandria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2024

Primary Completion (Actual)

August 10, 2025

Study Completion (Actual)

August 10, 2025

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0108172

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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