Efficacy and Safety of Oral Isotretinoin for the Treatment of Facial Recalcitrant Flat Warts

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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 primary endpoint will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Dermatológico Dr. Ladislao de la Pascua
• Treatments: Isotretinoin

Criteria

Inclusion Criteria:

• 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 Criteria:

• Have the following conditions:

1. Hypercholesterolemia

2. Hypertriglyceridemia

3. Liver disease

4. Renal disease

5. Sjögren syndrome

6. Pregnancy

7. Lactation

8. Depressive disorder

9. Body mass index less than 18 points or higher than 25 points

10. Contraindications for hormonal contraception or intrauterine device.