ClinicalTrials.gg
CompletedNCT07461103Updated Mar 10, 2026

Effect of Topical Insulin on Healing Rate of Pemphigus Lesions

A Phase 2 interventional study of insulin glargine and human insulin in Pemphigus Vulgaris, Skin Erosion and Autoimmune Blistering Disease, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Alexandria University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jun 2024, registered Mar 2026).
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pemphigus Vulgaris
  • Skin Erosion
  • Autoimmune Blistering Disease

Keywords

  • pemphigus vulgaris
  • topical insulin
  • wound healing
  • Insulin Glargine
  • Regular Insulin
  • Autoimmune Blistering Disease
  • Erosions
03

In context

Pemphigus

76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.

This study's enrollment of 20 is below the median of 30 across 53 interventional studies indexed under Pemphigus.

Browse Pemphigus studies →

Lead sponsor

Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Long-acting insulin (LA)

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

    Drug: insulin glargine

  • Experimental
    Regular human insulin (SA)

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

    Drug: human insulin

  • Placebo comparator
    control

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

    Drug: 0.9% Normal Saline

Interventions

  • 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

  • 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

  • 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

    Also known as: control, placebo

06

What researchers measure

Primary outcomes

  1. Time to Complete Healing

    Number of days required for complete epithelialization of the lesion

    Time frame: Up to 14 days

Secondary outcomes

  1. Lesion Surface Area Reduction

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

    Time frame: Baseline, Day 7, Day 14

  2. Daily Healing Rate

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

    Time frame: 14 days

07

Study locations

1 site
  • Alexandria main university hospital, Department of Dermatology and Venereology
    Alexandria, 22301, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2024 to primary completion in Aug 2025, 13 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2026
First posted
Mar 10, 2026
StartActual
Jun 22, 2024
Primary completionActual
Aug 10, 2025
CompletionActual
Aug 10, 2025
Last update
Mar 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07461103
Responsible party
Sponsor
First posted
Mar 10, 2026
Start date
Jun 22, 2024
Primary completion
Aug 10, 2025
Completion
Aug 10, 2025
Last update
Mar 10, 2026

Study contacts

Tarek M Hussein, MB BCh, MD
principal investigator · University of Alexandria
Carmen I Farid, MB BCh, MD
principal investigator · University of Alexandria

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Insulin Glargine · Insulin, Regular, Human

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