DSAP Treatment Comparison

• Status: Active, not recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will analyze the effects of topical lovastatin/cholesterol vs topical lovastatin alone in patients with disseminated superficial actinic porokeratosis. Patients will be divided into two groups, topical lovastatin/cholesterol and topical lovastatin alone. Patients will apply topical treatment twice daily to lesions over the course of 12 weeks. Follow up will occur in the virtual setting and photographs will be used to document progress.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Dihydromevinolin; L 647318; Lovastatin

Criteria

Inclusion Criteria:

• All patients 18 years and older with the diagnosis of disseminated superficial actinic porokeratosis.

Exclusion Criteria:

• Patients with allergies or contraindications to lovastatin or cholesterol

• Female patients currently pregnant or lactating.

• Female patients with plans to become pregnant.

• Patients actively taking approved forms of long-term contraception (oral contraceptives, implantable intrauterine devices, or other hormone eluting implants) will be allowed to participate as long as they have no plan to become pregnant during the course of the study. A urine pregnancy test will be administered to these patients to confirm that they can be included in the study.

• Inability or unwillingness of subject or legal guardian/representative to give informed consent