Clinical trial NCT05594472: Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid
Official title: Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid Compared to Conventional Topical Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pemphigus Vulgaris
Bullous Pemphigoid
Keywords: Ozonated olive oil
Healing
Disinfection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A self controlled study on 2 contralateral comparative skin lesions
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.

Exclusion Criteria:

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

Primary outcomes:
measure: Healing promoting effect of ozonated olive oil
timeFrame: 5 days per patient
Secondary outcomes:
measure: Disinfectant effect of ozonated olive oil
timeFrame: 5 days per patient
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dermatology Department, Cairo University Hospitals
Study officials:
affiliation: Faculty of pharmacy, Ain Shams University
name: Mohamed El-Shazly, MD
role: STUDY_CHAIR
References: