A Phase 3 interventional study of Ozonated olive oil and Topical garamycin cream in Pemphigus Vulgaris and Bullous Pemphigoid, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Cairo University · Phase 3, Interventional, and Treatment
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.
All participants will be subjected to the following:
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.
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 53 interventional studies indexed under Pemphigus.
Browse Pemphigus studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.
Exclusion Criteria:
ozonated oil will be applied to on one lesion followed by gauze for 5 consecutive days.
Drug: Ozonated olive oil
conventional topical treatment will be applied to a comparable lesion followed by gauze for 5 consecutive days.
Drug: Topical garamycin cream
Topical treatment will be applied for 5 consecutive days on the erosions.
Conventional topical treatment will be applied for 5 consecutive days on a comparable erosion
Healing promoting effect of ozonated olive oil
comparing percent change in surface area by digital planimetry in 2 selected comparable lesion
Time frame: 5 days per patient
Disinfectant effect of ozonated olive oil
Comparing incidence of bacterial and fungal growth in the 2 arms
Time frame: 5 days per patient
Plan to share: Yes — Participants' data that underlie reported results will be shared upon request, after deidentification
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Apr 2023, 5 months after the start.
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This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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