Status:
UNKNOWN
Efficacy and Safety of Oral Isotretinoin for the Treatment of Facial Recalcitrant Flat Warts
Lead Sponsor:
Centro Dermatológico Dr. Ladislao de la Pascua
Conditions:
Flat Wart
Eligibility:
All Genders
18-40 years
Phase:
PHASE3
Brief Summary
Randomized clinical trial to compare the efficacy of different doses of oral isotretinoin 10 mg/day, 20 mg/day and 30 mg/day during 12 weeks for the treatment of facial recalcitrant flat warts. The pr...
Detailed Description
The investigators will recruit 162 participants with facial recalcitrant flat warts and randomize to the following three arms of intervention: Arm 1: nne capsule of isotretinoin 10 mg plus one capsule...
Eligibility Criteria
Inclusion
- Clinical and histological diagnosis of facial flats warts
- More than 2 years with facial flat warts
- Without response to 2 or more topical interventions (tretinoin, imiquimod, cryosurgery and 5-fluorouracil) or oral interventions (cimetidine or zinc sulfate)
Exclusion
- Have the following conditions:
- Hypercholesterolemia
- Hypertriglyceridemia
- Liver disease
- Renal disease
- Sjögren syndrome
- Pregnancy
- Lactation
- Depressive disorder
- Body mass index less than 18 points or higher than 25 points
- Contraindications for hormonal contraception or intrauterine device.
Key Trial Info
Start Date :
March 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT04290572
Start Date
March 15 2020
End Date
December 31 2023
Last Update
March 3 2020
Active Locations (1)
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1
Centro Dermatológico "Dr. Ladislao de la Pascua"
Mexico City, Mexico, 06780