Back to resultsOzonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid
Primary Purpose
Pemphigus Vulgaris, Bullous Pemphigoid
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Ozonated olive oil
Topical garamycin cream
Sponsored by
About this trial
This is an interventional treatment trial for Pemphigus Vulgaris focused on measuring Ozonated olive oil, Healing, Disinfection
Eligibility Criteria
Inclusion Criteria:
Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.
Exclusion Criteria:
- Age < 18 years . Pregnant/ lactating females.
Sites / Locations
- Dermatology Department, Cairo University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ozonated olive oil
Topical garamycin cream
Arm Description
ozonated oil will be applied to on one lesion followed by gauze for 5 consecutive days.
conventional topical treatment will be applied to a comparable lesion followed by gauze for 5 consecutive days.
Outcomes
Primary Outcome Measures
Healing promoting effect of ozonated olive oil
comparing percent change in surface area by digital planimetry in 2 selected comparable lesion
Secondary Outcome Measures
Disinfectant effect of ozonated olive oil
Comparing incidence of bacterial and fungal growth in the 2 arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05594472
Brief Title
Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid
Official Title
Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid Compared to Conventional Topical Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pemphigus Vulgaris, Bullous Pemphigoid
Keywords
Ozonated olive oil, Healing, Disinfection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A self controlled study on 2 contralateral comparative skin lesions
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ozonated olive oil
Arm Type
Experimental
Arm Description
ozonated oil will be applied to on one lesion followed by gauze for 5 consecutive days.
Arm Title
Topical garamycin cream
Arm Type
Active Comparator
Arm Description
conventional topical treatment will be applied to a comparable lesion followed by gauze for 5 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Ozonated olive oil
Intervention Description
Topical treatment will be applied for 5 consecutive days on the erosions.
Intervention Type
Drug
Intervention Name(s)
Topical garamycin cream
Intervention Description
Conventional topical treatment will be applied for 5 consecutive days on a comparable erosion
Primary Outcome Measure Information:
Title
Healing promoting effect of ozonated olive oil
Description
comparing percent change in surface area by digital planimetry in 2 selected comparable lesion
Time Frame
5 days per patient
Secondary Outcome Measure Information:
Title
Disinfectant effect of ozonated olive oil
Description
Comparing incidence of bacterial and fungal growth in the 2 arms
Time Frame
5 days per patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.
Exclusion Criteria:
- Age < 18 years . Pregnant/ lactating females.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rania M Mogawer, MD
Phone
01068165330
Ext
002
Email
Raniamogawer@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Mourad, MD
Phone
0 102 153 4245
Ext
002
Email
ahmedhm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed El-Shazly, MD
Organizational Affiliation
Faculty of pharmacy, Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Dermatology Department, Cairo University Hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rania Mogawe, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Participants' data that underlie reported results will be shared upon request, after deidentification
IPD Sharing Time Frame
Beginning 3 months and up to 12 months after article publication.
IPD Sharing Access Criteria
Controlled Access:
Researchers who provide a methodologically sound proposal will be allowed to access data to achieve aims in the approved proposal.
Learn more about this trial
Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid
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