Pemphigus VulgarisPhase 2NCT07461103
Effect of Topical Insulin on Healing Rate of Pemphigus Lesions
A Phase 2 study testing insulin glargine, human insulin and 0.9% Normal Saline in people with Pemphigus Vulgaris and Skin Erosion, run by Alexandria University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pemphigus Vulgaris, Skin Erosion, Autoimmune Blistering Disease
- What is being tested?
- insulin glargine, human insulin and 0.9% Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2024to 10 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Alexandria main university hospital, Department of Dermatology and Venereology
Alexandria, 22301
About this study
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.
- Being tested
- insulin glargine, human insulin, 0.9% Normal Saline
- Keywords
- pemphigus vulgaris, topical insulin, wound healing, Insulin Glargine, Regular Insulin, Autoimmune Blistering Disease, Erosions
- Medical subject headings
- Pemphigus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin glargineDrug
Also called lantus
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
human insulinDrug
Also called actrapid
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 SalineDrug
Also called control, placebo
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
| Study group | Role | What they receive |
|---|---|---|
| Long-acting insulin (LA) | Experimental | Lesions treated with topical insulin glargine (Lantus) 0.1 mL per 10 cm² twice daily Receives: Drug: insulin glargine |
| Regular human insulin (SA) | Experimental | Lesions treated with topical regular insulin (Actrapid) 0.1 mL per 10 cm² twice daily Receives: Drug: human insulin |
| control | Placebo comparator | Lesions treated with topical 0.9% normal saline 0.1 mL per 10 cm² twice daily Receives: Drug: 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Healing
Number of days required for complete epithelialization of the lesion
Measured: Up to 14 days
Secondary outcomes (2)
Lesion Surface Area Reduction
Percentage reduction in lesion surface area from baseline,Measured using ImageJ software from standardized photographs
Measured: Baseline, Day 7, Day 14
Daily Healing Rate
Percentage of healing per day,Calculated as percentage of surface area reduction per day
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start22 Jun 2024
- Primary completion10 Aug 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pemphigus VulgarisStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, parallel-group, randomized controlled trial Within-patient comparison design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarek M Hussein, MB BCh, MD, Principal investigator, University of AlexandriaCarmen I Farid, MB BCh, MD, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461103
- Sponsor's protocol ID
- 0108172
- Status last verified
- Feb 2026
- First submitted
- 5 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Insulin on Healing Rate of Pemphigus Lesions
- ClinicalTrials.gov ID
- NCT07461103
- Acronym / sponsor ID
- 0108172
- Keywords
- pemphigus vulgaris, topical insulin, wound healing, Insulin Glargine, Regular Insulin, Autoimmune Blistering Disease, Erosions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 22 Jun 2024 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three-arm, parallel-group, randomized controlled trial Within-patient comparison design
| Arm | Type | Receives |
|---|---|---|
| Long-acting insulin (LA) | Experimental | Drug: insulin glargineLesions treated with topical insulin glargine (Lantus) 0.1 mL per 10 cm² twice daily |
| Regular human insulin (SA) | Experimental | Drug: human insulinLesions treated with topical regular insulin (Actrapid) 0.1 mL per 10 cm² twice daily |
| control | Placebo comparator | Drug: 0.9% Normal SalineLesions treated with topical 0.9% normal saline 0.1 mL per 10 cm² twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin glargineAlso: lantusTopical 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 | Drug | Long-acting insulin (LA) |
| human insulinAlso: actrapidtopical 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 | Drug | Regular human insulin (SA) |
| 0.9% Normal SalineAlso: control, placeboTopical 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 | Drug | control |
Primary outcome
Time to Complete Healing
Time frame: Up to 14 days
Number of days required for complete epithelialization of the lesion
2 secondary outcomes
Lesion Surface Area Reduction
Time frame: Baseline, Day 7, Day 14
Daily Healing Rate
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek M Hussein, MB BCh, MD principal investigator
University of Alexandria
Carmen I Farid, MB BCh, MD principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing insulin glargine, human insulin and 0.9% Normal Saline in people with Pemphigus Vulgaris and Skin Erosion, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Complete Healing (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.