Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid
NCT ID: NCT05594472
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
30 participants
INTERVENTIONAL
2022-11-01
2023-06-30
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ozonated olive oil
ozonated oil will be applied to on one lesion followed by gauze for 5 consecutive days.
Ozonated olive oil
Topical treatment will be applied for 5 consecutive days on the erosions.
Topical garamycin cream
conventional topical treatment will be applied to a comparable lesion followed by gauze for 5 consecutive days.
Topical garamycin cream
Conventional topical treatment will be applied for 5 consecutive days on a comparable erosion
Interventions
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Ozonated olive oil
Topical treatment will be applied for 5 consecutive days on the erosions.
Topical garamycin cream
Conventional topical treatment will be applied for 5 consecutive days on a comparable erosion
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Rania Mogawer
Consultant and lecturer of dermatology
Principal Investigators
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Mohamed El-Shazly, MD
Role: STUDY_CHAIR
Faculty of pharmacy, Ain Shams University
Locations
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Dermatology Department, Cairo University Hospitals
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Rania Mogawe, MD
Role: primary
Other Identifiers
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N-63-2021
Identifier Type: -
Identifier Source: org_study_id
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