Pemphigus VulgarisPhase 3NCT05594472
Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid
A Phase 3 study testing Ozonated olive oil and Topical garamycin cream in people with Pemphigus Vulgaris and Bullous Pemphigoid, run by Cairo University at 1 site in Egypt.
Trial summary
This study assesses the disinfectant and healing promoting effect of ozonated olive oil in treatment of pemphigus vulgaris and bullous pemphigoid in comparison to conventional topical treatment with topical antibiotic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pemphigus Vulgaris, Bullous Pemphigoid
- What is being tested?
- Ozonated olive oil and Topical garamycin cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 30 Jun 2023
- Phase
- Phase 3
- 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
- Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.
Who cannot join
- Age < 18 years . Pregnant/ lactating females.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Dermatology Department, Cairo University Hospitals
Cairo
Rania Mogawe, MD
About this study
Official title: Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid Compared to Conventional Topical Treatment
This study assesses the disinfectant and healing promoting effect of ozonated olive oil in treatment of pemphigus vulgaris and bullous pemphigoid in comparison to conventional topical treatment with topical antibiotic.
Read the detailed description
All participants will be subjected to the following:
- Written informed consent.
- Detailed history and clinical examination and photographic documentation
- Patients with pemphigus vulgaris (epidermal skin blisters) as well as those with bullous pemphigoid (subepidermal skin blisters) will receive systemic treatment, namely; pulse steroid therapy and either mycophenolate mofetil or azathioprine +/- monthly IV cyclophosphamide.
- Two comparable contralateral lesions will be selected in every patient, which will be randomly assigned to either ozonated oil or conventional treatment.
- Patients will apply ozonated oil to on one lesion followed by gauze compared to conventional topical gentamycin and potassium permanganate followed by gauze on the contralateral lesion. Role of topical treatment is essentially to prevent / treat secondary bacterial infection of skin erosions as well as promote wound healing by maintaining moist clean environment.
- Surface area of both lesions will be calculated using digital planimetry, prior to starting treatment and by the end of treatment; namely end of the first cycle of intravenous pulse steroids on day 6 which defines end of intervention. Percent reduction on either side will be calculated.
- For assessing disinfectant effect, swabs will be taken from the 2 selected lesions at the same intervals for assessing for bacterial as well as fungal growth.
- Patients with positive cultures for bacterial growth will be given systemic antibiotics according to culture and sensitivity
- Conditions
- Pemphigus Vulgaris, Bullous Pemphigoid
- Being tested
- Ozonated olive oil, Topical garamycin cream
- Keywords
- Ozonated olive oil, Healing, Disinfection
- Medical subject headings
- Pemphigus, Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonated olive oilDrug
Topical treatment will be applied for 5 consecutive days on the erosions.
Topical garamycin creamDrug
Conventional topical treatment will be applied for 5 consecutive days on a comparable erosion
| Study group | Role | What they receive |
|---|---|---|
| Ozonated olive oil | Experimental | ozonated oil will be applied to on one lesion followed by gauze for 5 consecutive days. Receives: Drug: Ozonated olive oil |
| Topical garamycin cream | Active comparator | conventional topical treatment will be applied to a comparable lesion followed by gauze for 5 consecutive days. Receives: Drug: Topical garamycin cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing promoting effect of ozonated olive oil
comparing percent change in surface area by digital planimetry in 2 selected comparable lesion
Measured: 5 days per patient
Secondary outcomes (1)
Disinfectant effect of ozonated olive oil
Comparing incidence of bacterial and fungal growth in the 2 arms
Measured: 5 days per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Nov 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
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 Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A self controlled study on 2 contralateral comparative skin lesions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mogawer, Cairo University
- Investigators
- Mohamed El-Shazly, MD, Study chair, Faculty of pharmacy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594472
- Sponsor's protocol ID
- N-63-2021
- Status last verified
- Nov 2022
- First submitted
- 21 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' data that underlie reported results will be shared upon request, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid Compared to Conventional Topical Treatment
- ClinicalTrials.gov ID
- NCT05594472
- Acronym / sponsor ID
- N-63-2021
- Conditions
- Pemphigus Vulgaris, Bullous Pemphigoid
- Keywords
- Ozonated olive oil, Healing, Disinfection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 26 Oct 2022 (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 assesses the disinfectant and healing promoting effect of ozonated olive oil in treatment of pemphigus vulgaris and bullous pemphigoid in comparison to conventional topical treatment with topical antibiotic.
Detailed description
All participants will be subjected to the following:
- Written informed consent.
- Detailed history and clinical examination and photographic documentation
- Patients with pemphigus vulgaris (epidermal skin blisters) as well as those with bullous pemphigoid (subepidermal skin blisters) will receive systemic treatment, namely; pulse steroid therapy and either mycophenolate mofetil or azathioprine +/- monthly IV cyclophosphamide.
- Two comparable contralateral lesions will be selected in every patient, which will be randomly assigned to either ozonated oil or conventional treatment.
- Patients will apply ozonated oil to on one lesion followed by gauze compared to conventional topical gentamycin and potassium permanganate followed by gauze on the contralateral lesion. Role of topical treatment is essentially to prevent / treat secondary bacterial infection of skin erosions as well as promote wound healing by maintaining moist clean environment.
- Surface area of both lesions will be calculated using digital planimetry, prior to starting treatment and by the end of treatment; namely end of the first cycle of intravenous pulse steroids on day 6 which defines end of intervention. Percent reduction on either side will be calculated.
- For assessing disinfectant effect, swabs will be taken from the 2 selected lesions at the same intervals for assessing for bacterial as well as fungal growth.
- Patients with positive cultures for bacterial growth will be given systemic antibiotics according to culture and sensitivity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A self controlled study on 2 contralateral comparative skin lesions
| Arm | Type | Receives |
|---|---|---|
| Ozonated olive oil | Experimental | Drug: Ozonated olive oilozonated oil will be applied to on one lesion followed by gauze for 5 consecutive days. |
| Topical garamycin cream | Active comparator | Drug: Topical garamycin creamconventional topical treatment will be applied to a comparable lesion followed by gauze for 5 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.
Key exclusion criteria (1 listed)
- Age < 18 years . Pregnant/ lactating females.
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 |
|---|---|---|
| Ozonated olive oilTopical treatment will be applied for 5 consecutive days on the erosions. | Drug | Ozonated olive oil |
| Topical garamycin creamConventional topical treatment will be applied for 5 consecutive days on a comparable erosion | Drug | Topical garamycin cream |
Primary outcome
Healing promoting effect of ozonated olive oil
Time frame: 5 days per patient
comparing percent change in surface area by digital planimetry in 2 selected comparable lesion
1 secondary outcome
Disinfectant effect of ozonated olive oil
Time frame: 5 days per patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: Yes. Participants' data that underlie reported results will be shared upon request, after deidentification
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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.
Mohamed El-Shazly, MD study chair
Faculty of pharmacy, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ozonated olive oil and Topical garamycin cream in people with Pemphigus Vulgaris and Bullous Pemphigoid, run by Cairo 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Nov 2022. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania M Mogawer, MD (01068165330 ext. 002, Raniamogawer@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing promoting effect of ozonated olive oil (time frame: 5 days per patient). 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 8 Nov 2022.