Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05594472|
Recruitment Status : Recruiting
First Posted : October 26, 2022
Last Update Posted : November 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pemphigus Vulgaris Bullous Pemphigoid||Drug: Ozonated olive oil Drug: Topical garamycin cream||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A self controlled study on 2 contralateral comparative skin lesions|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid Compared to Conventional Topical Treatment|
|Actual Study Start Date :||November 1, 2022|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Experimental: Ozonated olive oil
ozonated oil will be applied to on one lesion followed by gauze for 5 consecutive days.
Drug: Ozonated olive oil
Topical treatment will be applied for 5 consecutive days on the erosions.
Active Comparator: Topical garamycin cream
conventional topical treatment will be applied to a comparable lesion followed by gauze for 5 consecutive days.
Drug: Topical garamycin cream
Conventional topical treatment will be applied for 5 consecutive days on a comparable erosion
- 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
- Disinfectant effect of ozonated olive oil [ Time Frame: 5 days per patient ]Comparing incidence of bacterial and fungal growth in the 2 arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05594472
|Contact: Rania M Mogawer, MD||01068165330 ext 002||Raniamogawer@kasralainy.edu.eg|
|Contact: Ahmed Mourad, MD||0 102 153 4245 ext email@example.com|
|Dermatology Department, Cairo University Hospitals||Recruiting|
|Contact: Rania Mogawe, MD|
|Study Chair:||Mohamed El-Shazly, MD||Faculty of pharmacy, Ain Shams University|