NCT04290572

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

Efficacy and Safety of Oral Isotretinoin 10 mg, 20 mg and 30 mg for the Treatment of Facial Recalcitrant Flat Warts at Centro Dermatológico "Dr. Ladislao de la Pascua": Randomized Double-blinded Clinical Trial of Three Arms

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Centro Dermatológico Dr. Ladislao de la Pascua · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

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 of placebo, per day during 12 weeks; Arm 2: one capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks; and Arm 3: one capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks. The primary endpoints 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; and the incidence of side effects related to oral isotretinoin treatment among the 3 arms of treatment.

Conditions

• Flat Wart

Interventions

Type	Name	Description
DRUG	Isotretinoin capsules	Jelly capsules of isotretinoin

Timeline

• Start date: 2020-03-15
• Primary completion: 2023-02-28
• Completion: 2023-12-31
• First posted: 2020-03-02
• Last updated: 2020-03-03

Locations

1 site across 1 country: Mexico