Phase 1
N=31
DSAP Treatment Comparison: 2% Lovastatin/ 2% Cholesterol vs 2% Lovastatin Alone
Actinic Porokeratosis
Bottom Line
View on ClinicalTrials.gov: NCT04359823 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Measurement of Treatment Efficacy Determined by DSAP-GASI Score (Disseminated Actinic Porokeratosis General Assessment Severity Index) — 50.0; 51.4 Percent decrease in mean DSAP-GASI score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Lovastatin 2%, 2% Cholesterol Cream (Drug); Lovastatin 2% Cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Treatment Efficacy Determined by DSAP-GASI Score (Disseminated Actinic Porokeratosis General Assessment Severity Index) |
50.0; 51.4 | — |
| PRIMARY Presence of Coronoid Lamella on Dermoscopy (or Photograph). |
— | — |
| PRIMARY Actinic Keratosis Field Assessment Scale |
— | — |
| SECONDARY Improvement in Dermatology Quality of Life Index Questionnaire |
48; 38 | — |
| SECONDARY Improvement in Overall Appearance of DSAP Lesions |
14; 12 | — |
| SECONDARY Improvement in Color of DSAP Lesions |
13; 12 | — |
| SECONDARY Improvement in Size of DSAP Lesions |
12; 11 | — |
| SECONDARY Pain and Itch Associated With Treatment |
5; 1; 1; 1; 2; 0 | — |
| SECONDARY Application Frequency Influence on Disseminated Actinic Porokeratosis General Assessment Severity Index |
1.42; 1.54 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04359823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.