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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.