Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid

NCT05594472 | Unknown Phase 3 DMC

• 1 other identifier: N-63-2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pemphigus Vulgaris; Bullous Pemphigoid

Keywords

Ozonated olive oil; Healing; Disinfection

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Disinfectant effect of ozonated olive oil

  5 days per patient

Study Arms (2)

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

Ozonated olive oil DRUG

Topical treatment will be applied for 5 consecutive days on the erosions.

Ozonated olive oil

Topical garamycin cream DRUG

Conventional topical treatment will be applied for 5 consecutive days on a comparable erosion

Topical garamycin cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.

You may not qualify if:

• \- Age \< 18 years . Pregnant/ lactating females.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dermatology Department, Cairo University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pemphigus; Pemphigoid, Bullous

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mohamed El-Shazly, MD

  Faculty of pharmacy, Ain Shams University

  STUDY CHAIR

Central Study Contacts

Rania M Mogawer, MD

CONTACT

01068165330; Raniamogawer@kasralainy.edu.eg

Ahmed Mourad, MD

CONTACT

0 102 153 4245; ahmedhm@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant and lecturer of dermatology

Model Details: A self controlled study on 2 contralateral comparative skin lesions

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: November 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

EG (1)