DSAP Treatment Comparison: 2% Lovastatin/ 2% Cholesterol vs 2% Lovastatin Alone

NCT ID: NCT04359823

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-24
• Study Completion Date: 2021-04-23

Brief 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.

Detailed Description

The purpose of this study is to evaluate the effectiveness of cholesterol/lovastatin versus lovastatin alone to treat porokeratosis. Our working hypothesis is that both topical cholesterol/lovastatin and lovastatin alone are helpful in treating patients with disseminated superficial actinic porokeratosis (DSAP). Potential subjects will be approached by their care team member to be made aware of the study at MUSC Dermatology clinics. Subsequently, members of the study team will approach their own patients to ask for participation in this study. Pertinent project information, risks, and time commitment will be relayed to subjects. If subjects show interest in participating, they will be given consent forms to either sign or bring home for consideration. If the patient is eligible for the study, he or she will be randomly assigned to one of two groups. They will have a 50/50 chance of being in either group. You will not make the choice to which group you are assigned. The two groups are Group A (cholesterol/lovastatin) and Group B (lovastatin only). The patient will not be informed of which group they are in and will not be informed of what their study medication is, allowing single-blinding. Researchers will not be masked. Initial enrollment will occur virtually. Enrolled subjects will be followed up at monthly intervals for three months via virtual check-in. At each visit, participants will undergo brief physical examination; additionally, clinical photographs of the lesion will be obtained. Photographs will be stored in the electronic medical record and stored in a departmental secure drive for further analysis of lesion features. At each visit the novel DSAP- General Assessment Scale and RAND36 QoL scale will be administered. Patients will be contacted via virtual check-in visits at weeks 4, 8, and 12. Patients will be asked about compliance and any adverse effects experienced. Participants will also be contacted by phone by study team member to assess for any adverse effects at weeks 2 and 6 of treatment. Compounded topical medication prescribed to subjects will be self-applied twice daily. These medications will be prepared by Tide Water Pharmacy Charleston, SC and Chemistry RX Philadelphia, PA. Chemistry Rx will ship the medications to the patients. They will be prepared so the study will remain single-blinded. The associated costs will not be covered by the research budget. Dermoscopic and clinical photographs will be subsequently analyzed for the presence of cornoid lamella. The team will record any additional dermoscopic or clinicals feature that may arise during the analyses. Frequency of dermoscopic and clinical features will be analyzed against clinical involution to find possible predictors.

Conditions

Actinic Porokeratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Statin/Cholesterol Combination Group

This arm will utilize 2% cholesterol and 2% lovastatin ointment. It will be compounded by a pharmacist. Ointment will be applied on lesional skin with occlusion twice daily for 12 weeks.

Group Type: EXPERIMENTAL

Lovastatin 2%, 2% Cholesterol Cream

Intervention Type: DRUG

Patients selected to the study will be randomly assigned to this arm. They will have a 50% chance of being placed in this arm compared to the other arm.

Statin Alone Group

This arm will utilize 2% lovastatin ointment. It will be compounded by a pharmacist. Ointment will be applied on lesional skin with occlusion twice daily for 12 weeks.

Group Type: EXPERIMENTAL

Lovastatin 2% Cream

Intervention Type: DRUG

Patients selected to the study will be randomly assigned to this arm. They will have a 50% chance of being placed in this arm compared to the other arm.

Interventions

Lovastatin 2%, 2% Cholesterol Cream

Patients selected to the study will be randomly assigned to this arm. They will have a 50% chance of being placed in this arm compared to the other arm.

Intervention Type: DRUG

Lovastatin 2% Cream

Patients selected to the study will be randomly assigned to this arm. They will have a 50% chance of being placed in this arm compared to the other arm.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Dirk Elston, MD

Professor and Chairman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dirk Elston, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

Santa Lucia G, Snyder A, Lateef A, Drohan A, Gregoski MJ, Barton V, Elston DM. Safety and Efficacy of Topical Lovastatin Plus Cholesterol Cream vs Topical Lovastatin Cream Alone for the Treatment of Disseminated Superficial Actinic Porokeratosis: A Randomized Clinical Trial. JAMA Dermatol. 2023 May 1;159(5):488-495. doi: 10.1001/jamadermatol.2023.0205.

Reference Type: DERIVED

PMID: 36947042 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

00096259

Identifier Type: -

Identifier Source: org_study_id