Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid

Cairo University (CU)

Status and phase: Enrolling; Phase 3

Conditions: Pemphigus Vulgaris; Bullous Pemphigoid

Treatments: Drug: Ozonated olive oil; Drug: Topical garamycin cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05594472

N-63-2021

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.

Exclusion criteria

• Age < 18 years . Pregnant/ lactating females.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Ozonated olive oil

Experimental group

Description:

ozonated oil will be applied to on one lesion followed by gauze for 5 consecutive days.

Treatment:

Drug: Ozonated olive oil

Topical garamycin cream

Active Comparator group

Description:

conventional topical treatment will be applied to a comparable lesion followed by gauze for 5 consecutive days.

Treatment:

Drug: Topical garamycin cream