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Statin Alone Group for Actinic Porokeratosis (DSAP Trial)

Phase 1
Waitlist Available
Led By Dirk Elston, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* All patients 18 years and older with the diagnosis of disseminated superficial actinic porokeratosis.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial will study whether adding cholesterol to a topical lovastatin treatment plan can improve results for patients with a skin condition called superficial actinic porokeratosis.

Eligible Conditions
  • Actinic Porokeratosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Actinic keratosis
Measurement of Treatment Efficacy Determined by DSAP-GASI Score (Disseminated Actinic Porokeratosis General Assessment Severity Index)
Presence of Coronoid Lamella on Dermoscopy (or Photograph).
Secondary study objectives
Application Frequency Influence on Disseminated Actinic Porokeratosis General Assessment Severity Index
Improvement in Color of DSAP Lesions
Improvement in Dermatology Quality of Life Index Questionnaire
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Statin/Cholesterol Combination GroupExperimental Treatment1 Intervention
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 II: Statin Alone GroupExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cholesterol
FDA approved
Lovastatin 2% Cream
2020
Completed Phase 1
~40

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Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
961 Previous Clinical Trials
7,399,455 Total Patients Enrolled
Dirk Elston, MDPrincipal InvestigatorMedical University of South Carolina
2 Previous Clinical Trials
~6 spots leftby Sep 2025
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