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Effect of Topical Insulin on Healing Rate of Pemphigus Lesions

Plain-language guide to NCT07461103: phase 2 randomized trial of Insulin (regular human) and Insulin Glargine, 20 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07461103
Phase
phase 2
Status
completed
Start
2024-06-22
Completion (planned or actual)
2025-08-10
Participants
20 (actual)
Design
randomized, single-blind, treatment
Conditions studied
Pemphigus Vulgaris; Skin Erosion; Autoimmune Blistering Disease
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 2 trial, researchers set out to test Insulin (regular human) and Insulin Glargine.

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.

It had three arms (groups): Long-acting insulin (LA) (experimental), Regular human insulin (SA) (experimental) and control (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: lesions with clinical signs of secondary infection (purulence, surrounding erythema, fever); known allergy to insulin.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Insulin (regular human) was given.

Those kept unaware of assignments: participant.

It started in 2024-06-22 with completion listed for 2025-08-10.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to Complete Healing (time frame: Up to 14 days).

It also tracked 2 secondary outcomes, for example Daily Healing Rate.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) and Insulin Glargine in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Insulin Glargine compound page, all human trials.

Our Notes on the Compounds

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.