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Oral Isotretinoin for Facial Recalcitrant Flat Warts
NCT04290572Phase 3
Key facts
- Status
- Unknown
- Start
- Mar 2020
- Primary completion
- Feb 2023
- Countries
- 1
- Sponsor
- Centro Dermatológico Dr. Ladislao de la Pascua
- Modality
- Small Molecules
- Drugs
- isotretinoin
- Conditions
- verruca plana (VP)
01
Overview
Phase 3, randomised, double-blind trial of isotretinoin in verruca plana (VP) (3 arms), sponsored by Centro Dermatológico Dr. Ladislao de la Pascua. Primary endpoints: Proportion of participants with total remission of facial flat warts at 12 weeks and Incidence of serious adverse events related to oral isotretinoin treatment at 12 weeks. Status: unknown.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Isotretinoin 10 mg/day
One capsule of isotretinoin 10 mg plus one capsule of placebo, per day.
Isotretinoin 20 mg/day
One capsule of isotretinoin 20 mg plus one capsule of placebo, per day.
Isotretinoin 30 mg/day
One capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day.
03
Who it enrols
Patients with facial recalcitrant flat warts (>2 years) who have failed 2 or more topical or oral interventions.
04
Endpoints
Primary
Proportion of participants with total remission of facial flat warts
Incidence of serious adverse events related to oral isotretinoin treatment
Secondary
Quality of life index
Adherence to intervention
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