Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid

• ClinicalTrials.gov Identifier: NCT05594472
• Recruitment Status: Recruiting
• First Posted: October 26, 2022
• Last Update Posted: November 8, 2022
• Sponsor: Cairo University
• Information provided by (Responsible Party): Rania Mogawer, Cairo University

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Egypt

Dermatology Department, Cairo University Hospitals; Recruiting

Cairo, Egypt

Contact: Rania Mogawe, MD

Sponsors and Collaborators

Cairo University

Investigators

• Study Chair: Mohamed El-Shazly, MD; Faculty of pharmacy, Ain Shams University

More Information

• 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
• 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.

• 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:

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