Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid

Study Overview
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Brief Summary
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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
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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

Official Title
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Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid Compared to Conventional Topical Treatment

Conditions
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Pemphigus Vulgaris, Bullous Pemphigoid

Intervention / Treatment
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* Drug: Ozonated olive oil
* Drug: Topical garamycin cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions. Exclusion Criteria: - Age < 18 years . Pregnant/ lactating females.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A self controlled study on 2 contralateral comparative skin lesions
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ozonated olive oil<br>ozonated oil will be applied to on one lesion followed by gauze for 5 consecutive days. | Drug: Ozonated olive oil<br>* Topical treatment will be applied for 5 consecutive days on the erosions.<br>|
| Active Comparator: Topical garamycin cream<br>conventional topical treatment will be applied to a comparable lesion followed by gauze for 5 consecutive days. | Drug: Topical garamycin cream<br>* Conventional topical treatment will be applied for 5 consecutive days on a comparable erosion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing promoting effect of ozonated olive oil | comparing percent change in surface area by digital planimetry in 2 selected comparable lesion | 5 days per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disinfectant effect of ozonated olive oil | Comparing incidence of bacterial and fungal growth in the 2 arms | 5 days per patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ozonated olive oil, Healing, Disinfection