Trial Outcomes & Findings for DSAP Treatment Comparison: 2% Lovastatin/ 2% Cholesterol vs 2% Lovastatin Alone (NCT NCT04359823)
NCT ID: NCT04359823
Last Updated: 2023-12-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-12-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
14
|
|
Overall Study
COMPLETED
|
17
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Statin/Cholesterol Combination Group
n=17 Participants
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.
|
Statin Alone Group
n=14 Participants
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.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
n=17 Participants
|
57.3 years
n=14 Participants
|
58.3 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=17 Participants
|
13 Participants
n=14 Participants
|
26 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=17 Participants
|
1 Participants
n=14 Participants
|
5 Participants
n=31 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
14 participants
n=14 Participants
|
31 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Statin/Cholesterol Combination Group
n=12 Participants
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.
|
Statin Alone Group
n=12 Participants
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.
|
Statin Alone Group Itch Decrease
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.
|
Statin Alone Group Itch Increase
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.
|
Statin/Cholesterol Combination Group Pain Decrease
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.
|
Statin/Cholesterol Combination Group Pain Increase
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.
|
Statin Alone Group Pain Decrease
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.
|
Statin Alone Group Pain Increase
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.
|
|---|---|---|---|---|---|---|---|---|
|
Measurement of Treatment Efficacy Determined by DSAP-GASI Score (Disseminated Actinic Porokeratosis General Assessment Severity Index)
|
50.0 Percent decrease in mean DSAP-GASI score
|
51.4 Percent decrease in mean DSAP-GASI score
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: unable to complete due to COVID 19 pandemic causing virtual visits for most patients.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 weeksPopulation: Unable to accurately assess due to lack of in person visits during the covid 19 pandemic.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Statin/Cholesterol Combination Group
n=16 Participants
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.
|
Statin Alone Group
n=12 Participants
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.
|
Statin Alone Group Itch Decrease
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.
|
Statin Alone Group Itch Increase
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.
|
Statin/Cholesterol Combination Group Pain Decrease
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.
|
Statin/Cholesterol Combination Group Pain Increase
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.
|
Statin Alone Group Pain Decrease
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.
|
Statin Alone Group Pain Increase
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.
|
|---|---|---|---|---|---|---|---|---|
|
Improvement in Dermatology Quality of Life Index Questionnaire
|
48 Percent improvement in quality of life
|
38 Percent improvement in quality of life
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The numbers in each group do not equal the total number of analyzed participants because some declined to answer.
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.
Outcome measures
| Measure |
Statin/Cholesterol Combination Group
n=15 Participants
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.
|
Statin Alone Group
n=13 Participants
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.
|
Statin Alone Group Itch Decrease
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.
|
Statin Alone Group Itch Increase
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.
|
Statin/Cholesterol Combination Group Pain Decrease
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.
|
Statin/Cholesterol Combination Group Pain Increase
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.
|
Statin Alone Group Pain Decrease
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.
|
Statin Alone Group Pain Increase
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.
|
|---|---|---|---|---|---|---|---|---|
|
Improvement in Overall Appearance of DSAP Lesions
|
14 participants denoting a score of better
|
12 participants denoting a score of better
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The numbers in each group do not equal the total number of analyzed participants because some declined to answer.
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.
Outcome measures
| Measure |
Statin/Cholesterol Combination Group
n=15 Participants
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.
|
Statin Alone Group
n=13 Participants
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.
|
Statin Alone Group Itch Decrease
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.
|
Statin Alone Group Itch Increase
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.
|
Statin/Cholesterol Combination Group Pain Decrease
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.
|
Statin/Cholesterol Combination Group Pain Increase
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.
|
Statin Alone Group Pain Decrease
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.
|
Statin Alone Group Pain Increase
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.
|
|---|---|---|---|---|---|---|---|---|
|
Improvement in Color of DSAP Lesions
|
13 participants denoting a score of lighter
|
12 participants denoting a score of lighter
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The numbers in each group do not equal the total number of analyzed participants because some declined to answer.
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.
Outcome measures
| Measure |
Statin/Cholesterol Combination Group
n=15 Participants
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.
|
Statin Alone Group
n=13 Participants
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.
|
Statin Alone Group Itch Decrease
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.
|
Statin Alone Group Itch Increase
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.
|
Statin/Cholesterol Combination Group Pain Decrease
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.
|
Statin/Cholesterol Combination Group Pain Increase
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.
|
Statin Alone Group Pain Decrease
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.
|
Statin Alone Group Pain Increase
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.
|
|---|---|---|---|---|---|---|---|---|
|
Improvement in Size of DSAP Lesions
|
12 participants denoting smaller size
|
11 participants denoting smaller size
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Two participants did not complete the study from the statin group, thus were not allowed in final analysis.
Pain and Itch were measured as increased or decreased at weeks 0, 4, 8, and 12. Week 12 findings reported.
Outcome measures
| Measure |
Statin/Cholesterol Combination Group
n=17 Participants
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.
|
Statin Alone Group
n=17 Participants
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.
|
Statin Alone Group Itch Decrease
n=12 Participants
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.
|
Statin Alone Group Itch Increase
n=12 Participants
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.
|
Statin/Cholesterol Combination Group Pain Decrease
n=17 Participants
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.
|
Statin/Cholesterol Combination Group Pain Increase
n=17 Participants
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.
|
Statin Alone Group Pain Decrease
n=12 Participants
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.
|
Statin Alone Group Pain Increase
n=12 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Pain and Itch Associated With Treatment
|
5 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Statin/Cholesterol Combination Group
n=8 Participants
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.
|
Statin Alone Group
n=16 Participants
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.
|
Statin Alone Group Itch Decrease
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.
|
Statin Alone Group Itch Increase
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.
|
Statin/Cholesterol Combination Group Pain Decrease
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.
|
Statin/Cholesterol Combination Group Pain Increase
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.
|
Statin Alone Group Pain Decrease
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.
|
Statin Alone Group Pain Increase
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.
|
|---|---|---|---|---|---|---|---|---|
|
Application Frequency Influence on Disseminated Actinic Porokeratosis General Assessment Severity Index
|
1.42 score on a scale
Interval 0.77 to 2.06
|
1.54 score on a scale
Interval 0.9 to 2.19
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Statin/Cholesterol Combination Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Statin Alone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Statin/Cholesterol Combination Group
n=17 participants at risk
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.
|
Statin Alone Group
n=14 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
5.9%
1/17 • Number of events 1 • 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.
|
0.00%
0/14 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
5.9%
1/17 • Number of events 2 • 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.
|
0.00%
0/14 • 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.
|
|
Musculoskeletal and connective tissue disorders
Elevated CK
|
5.9%
1/17 • Number of events 1 • 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.
|
0.00%
0/14 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place