Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid

Bullous Pemphigoid Clinical Trial

Official title:

Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid Compared to Conventional Topical Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05594472
• Other study ID #: N-63-2021
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: Rania M Mogawer, MD
• Phone: 01068165330
• Email: Raniamogawer[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.

Exclusion Criteria:

• Age < 18 years . Pregnant/ lactating females.

Related Conditions & MeSH terms

• Bullous Pemphigoid
• Pemphigoid, Bullous
• Pemphigus
• Pemphigus Vulgaris

Intervention

Drug:
• Ozonated olive oil
Topical treatment will be applied for 5 consecutive days on the erosions.
• Topical garamycin cream
Conventional topical treatment will be applied for 5 consecutive days on a comparable erosion

Locations

Country	Name	City	State
Egypt	Dermatology Department, Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing promoting effect of ozonated olive oil	comparing percent change in surface area by digital planimetry in 2 selected comparable lesion	5 days per patient
Secondary	Disinfectant effect of ozonated olive oil	Comparing incidence of bacterial and fungal growth in the 2 arms	5 days per patient