Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05594472

Collaborator

(none)

Enrollment

Location

Arms

7.9

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

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

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A self controlled study on 2 contralateral comparative skin lesionsA 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 :

Nov 1, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Jun 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

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.

Exclusion Criteria:

Age < 18 years . Pregnant/ lactating females.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology Department, Cairo University Hospitals	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rania Mogawer, Consultant and lecturer of dermatology, Cairo University

ClinicalTrials.gov Identifier:

NCT05594472

Other Study ID Numbers:

N-63-2021

First Posted:

Oct 26, 2022

Last Update Posted:

Nov 8, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rania Mogawer, Consultant and lecturer of dermatology, Cairo University

Ozonated olive oil

Healing

Disinfection

Additional relevant MeSH terms:

Pemphigoid, Bullous

Pemphigus

Gentamicins

Study Results

No Results Posted as of Nov 8, 2022