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Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05594472
Enrollment
30
Registered
2022-10-26
Start date
2022-11-01
Completion date
2023-06-30
Last updated
2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pemphigus Vulgaris, Bullous Pemphigoid

Keywords

Ozonated olive oil, Healing, Disinfection

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

Interventions

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

DRUGTopical garamycin cream

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

A self controlled study on 2 contralateral comparative skin lesions

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Healing promoting effect of ozonated olive oil5 days per patientcomparing percent change in surface area by digital planimetry in 2 selected comparable lesion

Secondary

MeasureTime frameDescription
Disinfectant effect of ozonated olive oil5 days per patientComparing incidence of bacterial and fungal growth in the 2 arms

Countries

Egypt

Contacts

Primary ContactRania M Mogawer, MD
Raniamogawer@kasralainy.edu.eg01068165330
Backup ContactAhmed Mourad, MD
ahmedhm@gmail.com0 102 153 4245

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026