Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid

Phase 3

Recruiting

• Conditions: Pemphigus Vulgaris; Bullous Pemphigoid
• Interventions: Drug: Ozonated olive oil; Drug: Topical garamycin cream

• Registration Number: NCT05594472
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-26
• Status Verified: 2022-11
• Study Start: 2022-11-01
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-08
• Primary Completion: 2023-04-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.

Exclusion Criteria

• Age < 18 years . Pregnant/ lactating females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozonated olive oil	Ozonated olive oil	ozonated oil will be applied to on one lesion followed by gauze for 5 consecutive days.
Topical garamycin cream	Topical garamycin cream	conventional topical treatment will be applied to a comparable lesion followed by gauze for 5 consecutive days.

Primary Outcome Measures

Name	Time	Method
Healing promoting effect of ozonated olive oil	5 days per patient	comparing percent change in surface area by digital planimetry in 2 selected comparable lesion

Secondary Outcome Measures

Name	Time	Method
Disinfectant effect of ozonated olive oil	5 days per patient	Comparing incidence of bacterial and fungal growth in the 2 arms

Trial Locations

Locations (1)

Dermatology Department, Cairo University Hospitals; 🇪🇬 Cairo, Egypt