Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin/Cholesterol Combination Group | Experimental | 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. |
|
| Statin Alone Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lovastatin 2%, 2% Cholesterol Cream | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Treatment Efficacy Determined by DSAP-GASI Score (Disseminated Actinic Porokeratosis General Assessment Severity Index) | 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. | 12 weeks |
| Presence of Coronoid Lamella on Dermoscopy (or Photograph). | 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. | 12 weeks |
| Actinic Keratosis Field Assessment Scale | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Dermatology Quality of Life Index Questionnaire | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dirk Elston, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36947042 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. Lovastatin 2%: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measurement of Treatment Efficacy Determined by DSAP-GASI Score (Disseminated Actinic Porokeratosis General Assessment Severity Index) | 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. | Treatment efficacy was based on investigator-standardized patient-documented photographs. Repeat photo documentation was obtained if image quality was inadequate or angle, lighting or location was not standardized to prior photos. Thirty-one subjects enrolled in the study, of which 24 provided clear pictures across all four visits (i.e. ~77%) and were considered in the efficacy analysis. | Posted | Number | Percent decrease in mean DSAP-GASI score | 12 weeks |
|
12 weeks per participant (during participants study time period). Cumulatively about 6 months for all participants.
Patients had scheduled visits every 4 weeks and were asked about medication toleration. Participants were also contacted two weeks post/pre appointment about any possible new adverse events or new symptoms.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Patient noticed a rash on the inside of her right elbow. It was one of the many locations where she applied the cream. The rash has since went away after avoiding application to that area for a few days. She continued to use cream on other areas. |
Study was limited by covid pandemic requiring virtual appointments with participants. This prevented study team from acquiring in person dermoscopy data and overall limited physical exam assessments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriella Santa Lucia | MUSC | 724-413-8833 | santaluc@musc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 28, 2020 | Jan 5, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2022 | Jan 12, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 28, 2020 | Jan 12, 2022 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lovastatin 2% Cream | 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. |
|
| 12 weeks |
| Improvement in Overall Appearance of DSAP Lesions | 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 |
| Improvement in Color of DSAP Lesions | 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. | 12 weeks |
| Improvement in Size of DSAP Lesions | 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. | 12 weeks |
| Pain and Itch Associated With Treatment | Pain and Itch were measured as increased or decreased at weeks 0, 4, 8, and 12. Week 12 findings reported. | 12 weeks |
| Application Frequency Influence on Disseminated Actinic Porokeratosis General Assessment Severity Index | 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 |
| BG001 | 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. Lovastatin 2%: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| 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 daily for 12 weeks. 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. |
| OG001 | 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 daily for 12 weeks. Lovastatin 2%: 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. |
|
|
| Primary | Presence of Coronoid Lamella on Dermoscopy (or Photograph). | 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. | unable to complete due to COVID 19 pandemic causing virtual visits for most patients. | Posted | 12 weeks |
|
|
| Primary | Actinic Keratosis Field Assessment Scale | 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. | Unable to accurately assess due to lack of in person visits during the covid 19 pandemic. | Posted | 12 weeks |
|
|
| Secondary | Improvement in Dermatology Quality of Life Index Questionnaire | 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. | 3/31 participants did not return a questionnaire at visit 1 or 4. In the statin group 12/14 returned a questionnaire and 16/17 in the combination group. | Posted | Number | Percent improvement in quality of life | 12 weeks |
|
|
|
| Secondary | Improvement in Overall Appearance of DSAP Lesions | 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. | The numbers in each group do not equal the total number of analyzed participants because some declined to answer. | Posted | Number | participants denoting a score of better | 12 weeks |
|
|
|
| Secondary | Improvement in Color of DSAP Lesions | 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. | The numbers in each group do not equal the total number of analyzed participants because some declined to answer. | Posted | Number | participants denoting a score of lighter | 12 weeks |
|
|
|
| Secondary | Improvement in Size of DSAP Lesions | 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. | The numbers in each group do not equal the total number of analyzed participants because some declined to answer. | Posted | Number | participants denoting smaller size | 12 weeks |
|
|
|
| Secondary | Pain and Itch Associated With Treatment | Pain and Itch were measured as increased or decreased at weeks 0, 4, 8, and 12. Week 12 findings reported. | Two participants did not complete the study from the statin group, thus were not allowed in final analysis. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Application Frequency Influence on Disseminated Actinic Porokeratosis General Assessment Severity Index | 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. | Data was analyzed against DSAP-GASI scores that had n=12 for each treatment arm. Frequency was also analyzed in the 24 participants selected for the DSAP-GASI. 8 of those participants happened to be once a day and 16 twice a day. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 weeks |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 3 |
| 17 |
| EG001 | 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. Lovastatin 2%: 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. | 0 | 14 | 0 | 14 | 0 | 14 |
|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient emailed and said she "had muscle weakness ( felt like my legs were quivering) after standing in a sailboat to steer for 3 hours under stressful conditions and again after playing 4 hours of croquet in one day". Patient continued with study. |
|
| Elevated CK | Musculoskeletal and connective tissue disorders | Systematic Assessment | Subject's PCP has been monitoring her CK as a result of starting statin therapy. CK 664. PCP recommended continued participation in the study granted significant improvement of DSAP lesions and no symptoms or additional signs relevant to the therapy. |
|
Not provided
Not provided
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |