Trial · NCT04359823
DSAP Treatment Comparison: 2% Lovastatin/ 2% Cholesterol vs 2% Lovastatin Alone
NCT04359823, Phase 1, Completed, Medical University of South Carolina; results first posted 2023-12-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. DSAP Treatment Comparison: 2% Lovastatin/ 2% Cholesterol vs 2% Lovastatin Alone. Trials, record NCT04359823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04359823
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DSAP Treatment Comparison: 2% Lovastatin/ 2% Cholesterol vs 2% Lovastatin Alone
- NCT number
- NCT04359823
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 31 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Actinic Porokeratosis
- Interventions
- Lovastatin 2%, 2% Cholesterol Cream, Lovastatin 2% Cream
- First posted
- 2020-04-24
- Last updated
- 2023-12-07
- Results first posted
- 2023-12-07
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measurement of Treatment Efficacy Determined by DSAP-GASI Score (Disseminated Actinic Porokeratosis General Assessment Severity Index) | 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. |
| Primary | Presence of Coronoid Lamella on Dermoscopy (or Photograph). | 12 weeks | 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. |
| Primary | Actinic Keratosis Field Assessment Scale | 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. |
| Secondary | Improvement in Dermatology Quality of Life Index Questionnaire | 12 weeks | 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. |
| Secondary | Improvement in Overall Appearance of DSAP Lesions | 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. |
| Secondary | Improvement in Color of DSAP Lesions | 12 weeks | 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. |
| Secondary | Improvement in Size of DSAP Lesions | 12 weeks | 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. |
| Secondary | Pain and Itch Associated With Treatment | 12 weeks | Pain and Itch were measured as increased or decreased at weeks 0, 4, 8, and 12. Week 12 findings reported. |
| Secondary | Application Frequency Influence on Disseminated Actinic Porokeratosis General Assessment Severity Index | 12 weeks | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Measurement of Treatment Efficacy Determined by DSAP-GASI Score (Disseminated Actinic Porokeratosis General Assessment Severity Index) | 12 weeks | 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. | Percent decrease in mean DSAP-GASI score | NUMBER |
| PRIMARY | Presence of Coronoid Lamella on Dermoscopy (or Photograph). | 12 weeks | unable to complete due to COVID 19 pandemic causing virtual visits for most patients. | ||
| PRIMARY | Actinic Keratosis Field Assessment Scale | 12 weeks | Unable to accurately assess due to lack of in person visits during the covid 19 pandemic. | ||
| SECONDARY | Improvement in Dermatology Quality of Life Index Questionnaire | 12 weeks | 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. | Percent improvement in quality of life | NUMBER |
| SECONDARY | Improvement in Overall Appearance of DSAP Lesions | 12 weeks | The numbers in each group do not equal the total number of analyzed participants because some declined to answer. | participants denoting a score of better | NUMBER |
| SECONDARY | Improvement in Color of DSAP Lesions | 12 weeks | The numbers in each group do not equal the total number of analyzed participants because some declined to answer. | participants denoting a score of lighter | NUMBER |
| SECONDARY | Improvement in Size of DSAP Lesions | 12 weeks | The numbers in each group do not equal the total number of analyzed participants because some declined to answer. | participants denoting smaller size | NUMBER |
| SECONDARY | Pain and Itch Associated With Treatment | 12 weeks | Two participants did not complete the study from the statin group, thus were not allowed in final analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Application Frequency Influence on Disseminated Actinic Porokeratosis General Assessment Severity Index | 12 weeks | 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. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Measurement of Treatment Efficacy Determined by DSAP-GASI Score (Disseminated Actinic Porokeratosis General Assessment Severity Index) | Statin/Cholesterol Combination Group | 50.0 | Percent decrease in mean DSAP-GASI score | ||
| Measurement of Treatment Efficacy Determined by DSAP-GASI Score (Disseminated Actinic Porokeratosis General Assessment Severity Index) | Statin Alone Group | 51.4 | Percent decrease in mean DSAP-GASI score | ||
| Improvement in Dermatology Quality of Life Index Questionnaire | Statin/Cholesterol Combination Group | 48 | Percent improvement in quality of life | ||
| Improvement in Dermatology Quality of Life Index Questionnaire | Statin Alone Group | 38 | Percent improvement in quality of life | ||
| Improvement in Overall Appearance of DSAP Lesions | Statin/Cholesterol Combination Group | 14 | participants denoting a score of better | ||
| Improvement in Overall Appearance of DSAP Lesions | Statin Alone Group | 12 | participants denoting a score of better | ||
| Improvement in Color of DSAP Lesions | Statin/Cholesterol Combination Group | 13 | participants denoting a score of lighter | ||
| Improvement in Color of DSAP Lesions | Statin Alone Group | 12 | participants denoting a score of lighter | ||
| Improvement in Size of DSAP Lesions | Statin/Cholesterol Combination Group | 12 | participants denoting smaller size | ||
| Improvement in Size of DSAP Lesions | Statin Alone Group | 11 | participants denoting smaller size |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Statin/Cholesterol Combination Group | 17 | |
| Overall Study | STARTED | Statin Alone Group | 14 | |
| Overall Study | COMPLETED | Statin/Cholesterol Combination Group | 17 | |
| Overall Study | COMPLETED | Statin Alone Group | 12 | |
| Overall Study | NOT COMPLETED | Statin/Cholesterol Combination Group | 0 | |
| Overall Study | NOT COMPLETED | Statin Alone Group | 2 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | rash | Skin and subcutaneous tissue disorders | Statin/Cholesterol Combination Group | 1 | 17 | 1 |
| other | rash | Skin and subcutaneous tissue disorders | Statin Alone Group | 0 | 14 | 0 |
| other | Muscle Weakness | Musculoskeletal and connective tissue disorders | Statin/Cholesterol Combination Group | 1 | 17 | 2 |
| other | Muscle Weakness | Musculoskeletal and connective tissue disorders | Statin Alone Group | 0 | 14 | 0 |
| other | Elevated CK | Musculoskeletal and connective tissue disorders | Statin/Cholesterol Combination Group | 1 | 17 | 1 |
| other | Elevated CK | Musculoskeletal and connective tissue disorders | Statin Alone Group | 0 | 14 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Statin/Cholesterol Combination Group | 0 | 17 |
| Total, all-cause mortality | Statin Alone Group | 0 | 14 |
| Total, other adverse events | Statin/Cholesterol Combination Group | 3 | 17 |
| Total, other adverse events | Statin Alone Group | 0 | 14 |
| Total, serious adverse events | Statin/Cholesterol Combination Group | 0 | 17 |
| Total, serious adverse events | Statin Alone Group | 0 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36947042 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Statin/Cholesterol Combination Group vs Statin Alone Group: deaths from any cause | Trial comparisons |
| Statin/Cholesterol Combination Group vs Statin Alone Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04359823
GET https://conductscience.org/api/trials/v1/NCT04359823/registered