Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and... | NCT05594472

Studies
Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid

NCT05594472

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Nov 8, 2022Actual

Enrollment

30Estimated

Phase

Phase 3

Conditions

Pemphigus Vulgaris
Bullous Pemphigoid

Interventions

Ozonated olive oil
Topical garamycin cream

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2022Actual

Primary Completion Date

Apr 30, 2023Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Oct 21, 2022

First Submission Date that Met QC Criteria

Oct 21, 2022

First Posted Date

Oct 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2022

Last Update Posted Date

Nov 8, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rania Mogawer, Consultant and lecturer of dermatology, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ozonated olive oil	Experimental	ozonated oil will be applied to on one lesion followed by gauze for 5 consecutive days.	Drug: Ozonated olive oil
Topical garamycin cream	Active Comparator	conventional topical treatment will be applied to a comparable lesion followed by gauze for 5 consecutive days.	Drug: Topical garamycin cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ozonated olive oil	Drug	Topical treatment will be applied for 5 consecutive days on the erosions.	Ozonated olive oil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.

Exclusion Criteria:

- Age < 18 years . Pregnant/ lactating females.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rania M Mogawer, MD	Contact	01068165330	002	Raniamogawer@kasralainy.edu.eg
Ahmed Mourad, MD	Contact	0 102 153 4245	002	ahmedhm@gmail.com

Overall Officials

Name	Affiliation	Role
Mohamed El-Shazly, MD	Faculty of pharmacy, Ain Shams University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dermatology Department, Cairo University Hospitals	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Participants' data that underlie reported results will be shared upon request, after deidentification

Types

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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010392	Pemphigus
D010391	Pemphigoid, Bullous

Ancestor Terms

ID	Term
D012872	Skin Diseases, Vesiculobullous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases

Browse Leaves

Not provided

Browse Branches

Not provided