- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04359823
DSAP Treatment Comparison: 2% Lovastatin/ 2% Cholesterol vs 2% Lovastatin Alone (DSAP)
Topical Treatment for Superficial Disseminated Actinic Porokeratosis: A Single-Blinded Comparison Between Lovastatin/Cholesterol and Lovastatin
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
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Experimental: 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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Actinic Keratosis Field Assessment Scale
Time Frame: 12 weeks
|
The Actinic Keratosis Field Assessment Scale measures the percent area covered by actinic keratosis on a scale of 0-4 (0 being 0% and 4 being >50% total area on face or scalp), the severity of hyperkeratosis based upon size of lesion and degree of hyperkeratosis (considered positive findings if >1 actinic keratosis with significant hyperkeratosis and >5mm in diameter), and sun damage severity, measured positive (moderate or severe sun damage) or negative (none or mild damage), based upon severity of erythema, telangiectasia, inflammation, atrophy, and pigmentation disorders.
This will be used to determine skin changes (described above) during treatment.
A higher score would indicate a worse outcome.
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12 weeks
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Measurement of Treatment Efficacy Determined by DSAP-GASI Score (Disseminated Actinic Porokeratosis General Assessment Severity Index)
Time Frame: 12 weeks
|
The primary endpoint was the percentage of lesion clearance after 12 weeks of therapy using an exploratory clinical measure modified from a validated psoriasis index.
The Disseminated Actinic Porokeratosis General Assessment Severity Index (DSAP-GASI) included plaque/rim elevation, scaling, and color (0= clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
Lesions of each patient were graded by 2 blinded physicians before and after treatment.
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12 weeks
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Presence of Coronoid Lamella on Dermoscopy (or Photograph).
Time Frame: 12 weeks
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Dermoscopic and clinical photographs will be subsequently analyzed for the presence of cornoid lamella (well circumscribed, erythematous macule with a peripheral rim of hyperkeratosis).
The team will record any additional dermoscopic or clinicals feature that may arise during the analyses.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Dermatology Quality of Life Index Questionnaire
Time Frame: 12 weeks
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The patient quality of life scale asks 10 questions gaging how the patient skin condition is currently impacting their life. This questionnaire is a common validated tool, available free online. DLQI interpretation: no effect (0-1), mild effect (2-5), moderate effect (6-10), very large effect (11-20), extreme large effect (21-30). Lower scores represent improved quality of life. This was given after every visit at weeks 0, 4, 8, and 12 to access if the cream has contributed to quality of life improvement. The mean difference between the first (week 0) and last score (week 12) was used as the final improvement score. |
12 weeks
|
Improvement in Overall Appearance of DSAP Lesions
Time Frame: 12 weeks
|
Patients were asked if their overall appearance was better, unchanged, worse.
The responses were collected at weeks 4, 8, and 12.
Only the final visit (week 12) was used in analysis.
Better overall improvement is reported in the data table.
|
12 weeks
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Improvement in Color of DSAP Lesions
Time Frame: 12 weeks
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Patients were asked if their color was lighter, unchanged, darker.
The responses were collected at weeks 4, 8, and 12.
Only the final visit (week 12) was used in analysis.
Lighter coloring is reported in the data table.
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12 weeks
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Improvement in Size of DSAP Lesions
Time Frame: 12 weeks
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Patients were asked if their lesion size was smaller, unchanged, or larger.
The responses were collected at weeks 4, 8, and 12.
Only the final visit (week 12) was used in analysis.
The number of participants reporting smaller lesions is reported in the data table.
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12 weeks
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Pain and Itch Associated With Treatment
Time Frame: 12 weeks
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Pain and Itch were measured as increased or decreased at weeks 0, 4, 8, and 12. Week 12 findings reported.
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12 weeks
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Application Frequency Influence on Disseminated Actinic Porokeratosis General Assessment Severity Index
Time Frame: 12 weeks
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Measure if applying once or twice a day had an affect on treatment efficacy using the DSAP-GASI described in the primary outcome.
Factors included plaque/rim elevation, scaling, and color.
(0= clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
Lower score indicates better outcome.
|
12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Dirk Elston, MD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Keratosis
- Porokeratosis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Lovastatin
- L 647318
- Dihydromevinolin
Other Study ID Numbers
- 00096259
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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