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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-acting insulin (LA) | Experimental | Lesions treated with topical insulin glargine (Lantus) 0.1 mL per 10 cm² twice daily |
|
| Regular human insulin (SA) | Experimental | Lesions treated with topical regular insulin (Actrapid) 0.1 mL per 10 cm² twice daily |
|
| control | Placebo Comparator | Lesions treated with topical 0.9% normal saline 0.1 mL per 10 cm² twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete Healing | Number of days required for complete epithelialization of the lesion | Up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Surface Area Reduction | Percentage reduction in lesion surface area from baseline,Measured using ImageJ software from standardized photographs | Baseline, Day 7, Day 14 |
| Daily Healing Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tarek M Hussein, MB BCh, MD | University of Alexandria | Principal Investigator |
| Carmen I Farid, MB BCh, MD | University of Alexandria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria main university hospital, Department of Dermatology and Venereology | Alexandria | 22301 | Egypt |
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| ID | Term |
|---|---|
| D010392 | Pemphigus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D007328 | Insulin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Three-arm, parallel-group, randomized controlled trial Within-patient comparison design
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|
| 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 |
|
|
| 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 |
|
|
Percentage of healing per day,Calculated as percentage of surface area reduction per day
| 14 days |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011384 | Proinsulin |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |