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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
Sponsor:
Information provided by (Responsible Party):
Rania Mogawer, Cairo University

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.

Condition or disease Intervention/treatment Phase
Pemphigus Vulgaris Bullous Pemphigoid Drug: Ozonated olive oil Drug: Topical garamycin cream Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A self controlled study on 2 contralateral comparative skin lesions
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Disinfectant effect of ozonated olive oil [ Time Frame: 5 days per patient ]
    Comparing incidence of bacterial and fungal growth in the 2 arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.

Exclusion Criteria:

- Age < 18 years . Pregnant/ lactating females.


Information from the National Library of Medicine

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


Contacts
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Contact: Rania M Mogawer, MD 01068165330 ext 002 Raniamogawer@kasralainy.edu.eg
Contact: Ahmed Mourad, MD 0 102 153 4245 ext 002 ahmedhm@gmail.com

Locations
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Egypt
Dermatology Department, Cairo University Hospitals Recruiting
Cairo, Egypt
Contact: Rania Mogawe, MD         
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Mohamed El-Shazly, MD Faculty of pharmacy, Ain Shams University
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Responsible Party: Rania Mogawer, Consultant and lecturer of dermatology, Cairo University
ClinicalTrials.gov Identifier: NCT05594472    
Other Study ID Numbers: N-63-2021
First Posted: October 26, 2022    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants' data that underlie reported results will be shared upon request, after deidentification
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Beginning 3 months and up to 12 months after article publication.
Access Criteria:

Controlled Access:

Researchers who provide a methodologically sound proposal will be allowed to access data to achieve aims in the approved proposal.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rania Mogawer, Cairo University:
Ozonated olive oil
Healing
Disinfection
Additional relevant MeSH terms:
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Pemphigus
Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action