Trial · NCT01517893
Clinical Trial of Simvastatin to Treat Generalized Vitiligo
NCT01517893, Phase 2, Completed, John Harris; results first posted 2015-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Trial of Simvastatin to Treat Generalized Vitiligo. Trials, record NCT01517893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01517893
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial of Simvastatin to Treat Generalized Vitiligo
- NCT number
- NCT01517893
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- John Harris
- Conditions
- Vitiligo
- Interventions
- Simvastatin, Placebo
- First posted
- 2012-01-25
- Last updated
- 2018-11-14
- Results first posted
- 2015-03-12
- Limitations and caveats
The following outcome measures were abandoned: 1.Decrease in CXCR3 exp. on CD8 positive T-Cells, 2.Corr. Among Var. Outcome Measures for Vitiligo: procedures not performed/no data collected due to strength of prior outcomes \& budget limitation.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Decrease in Vitiligo Area Scoring Index (VASI) Score | Assessed at baseline and final study visit, 6 months after randomization | Number of participants with 33% decrease in the Vitiligo Area Scoring Index (VASI) from baseline to the last available study visit. Decrease in VASI score means improvement. Minimum value is 0, that means no vitiligo. maximum value is 100, that means 100% of the body surface area has vitiligo (total body surface area). |
| Secondary | Number of Participants With Increase in Investigator's Global Assessment Score | Assessed at baseline and final study visit, 6 months after randomization | Increase in Investigator Global Assessment Scores of 30% or more from baseline to last available visit. Increase in score means improvement. 0% is no improvement at all. 100% is complete recovery. |
| Secondary | Number of Participants Experiencing Toxicity From of High-dose Simvastatin . | Assessed at baseline, then monthly until final study visit, six months after randomization. | The number of participants who experienced toxicity based upon monitored lab values (Liver Function Test) and patient symptoms for evidence of simvastatin toxicity |
| Secondary | Change in Sentinel Patch Area | Assessed at baseline and final study visit, 6 months after randomization | Change in percent depigmentation of sentinel patch lesion from baseline to last available study visit ( 6 months after randomization). positive numbers mean increase or worsening of sentinel patch area negative numbers mean decrease or improvement of sentinel patch area |
| Secondary | Change in Quality of Life Score by Using DERMATOLOGY LIFE QUALITY INDEX (DLQI) | Assessed at baseline and final study visit, 6 months after randomization | The aim of this questionnaire is to measure how much your skin problem has affected your life. We measured change in questionnaire score from baseline to end of study (at 6 months after randomization) of subjects randomized to treatment with simvastatin versus placebo. Change was measured as a drop in score at the end of 6 months of treatment. Minimum score is 0, maximum is 30. Higher value means worse score. |
| Secondary | Number of Participants With an Increase in Patient's Global Assessment Score | Assessed at baseline and final study visit, 6 months after randomization | Increase in Patient's Global Assessment Scores of 30% or more from baseline to last available visit Increase means improvement. minimum is 0% and maximum is 100% |
| Secondary | Serum CXCL10 Levels From the First and Last Available Clinic Visits Were Measured Via ELISA | Assessed at baseline and final study visit, 6 months after randomization | Determination of the effects of simvastatin treatment on Serum CXCL10 levels from the first and last available clinic visits were measured via ELISA in the blood of patients with vitiligo treated with simvastatin versus placebo |
| Secondary | CXCR3 Expression on CD8+ T Cells | Assessed prior to treatment and periodically while on treatment | Determination of the effects of simvastatin treatment on CXCR3 expression in melanocyte-specific, autoreactive CD8+ T cells in the blood of patients with vitiligo treated with simvastatin versus placebo |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Decrease in Vitiligo Area Scoring Index (VASI) Score | Assessed at baseline and final study visit, 6 months after randomization | Overall number of participants for intervention (5) differs from enrollment (8) due to withdraw of 3 participants on intervention arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Increase in Investigator's Global Assessment Score | Assessed at baseline and final study visit, 6 months after randomization | For placebo arm, only 6 out of 7 participants reported data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Toxicity From of High-dose Simvastatin . | Assessed at baseline, then monthly until final study visit, six months after randomization. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Sentinel Patch Area | Assessed at baseline and final study visit, 6 months after randomization | cm2 | MEAN | |
| SECONDARY | Change in Quality of Life Score by Using DERMATOLOGY LIFE QUALITY INDEX (DLQI) | Assessed at baseline and final study visit, 6 months after randomization | units on a scale | MEAN | |
| SECONDARY | Number of Participants With an Increase in Patient's Global Assessment Score | Assessed at baseline and final study visit, 6 months after randomization | Placebo arm reports 6 instead of enrolled 7 due to failure of participant to complete assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum CXCL10 Levels From the First and Last Available Clinic Visits Were Measured Via ELISA | Assessed at baseline and final study visit, 6 months after randomization | Serum CXCL10 levels from the first and last available clinic visits were measured via ELISA. The mean and SEM are reported here. One participant in intervention group was not included because participant withdrew before a second CXCL10 level was obtained. Other withdrawn participants were included, using the CXCL10 from their final visits. | Fold change of baseline CXCL10 level | MEAN |
| SECONDARY | CXCR3 Expression on CD8+ T Cells | Assessed prior to treatment and periodically while on treatment | No data collected as this outcome was abandoned due to budget constraints and strength of other study results. |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Decrease in Vitiligo Area Scoring Index (VASI) Score | Intervention Arm | 0 | Participants | ||
| Number of Participants With a Decrease in Vitiligo Area Scoring Index (VASI) Score | Placebo Arm | 0 | Participants | ||
| Number of Participants With Increase in Investigator's Global Assessment Score | Intervention Arm | 1 | Participants | ||
| Number of Participants With Increase in Investigator's Global Assessment Score | Placebo Arm | 0 | Participants | ||
| Number of Participants Experiencing Toxicity From of High-dose Simvastatin . | Intervention Arm | 0 | Participants | ||
| Number of Participants Experiencing Toxicity From of High-dose Simvastatin . | Placebo Arm | 0 | Participants | ||
| Change in Sentinel Patch Area | Intervention Arm | -0.2272 | Standard Deviation 3.463 | cm2 | |
| Change in Sentinel Patch Area | Placebo Arm | 3.8571 | Standard Deviation 9.17 | cm2 | |
| Change in Quality of Life Score by Using DERMATOLOGY LIFE QUALITY INDEX (DLQI) | Intervention Arm | 3.4 | Standard Deviation 4.159326869 | units on a scale | |
| Change in Quality of Life Score by Using DERMATOLOGY LIFE QUALITY INDEX (DLQI) | Placebo Arm | 2.285714286 | Standard Deviation 2.690370837 | units on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention Arm | 8 | |
| Overall Study | STARTED | Placebo Arm | 7 | |
| Overall Study | COMPLETED | Intervention Arm | 5 | |
| Overall Study | COMPLETED | Placebo Arm | 7 | |
| Overall Study | NOT COMPLETED | Intervention Arm | 3 | |
| Overall Study | NOT COMPLETED | Placebo Arm | 0 |
Source ClinicalTrials.gov
Adverse events36
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 | back pain | Musculoskeletal and connective tissue disorders | Intervention Arm | 0 | 8 | |
| other | back pain | Musculoskeletal and connective tissue disorders | Placebo Arm | 1 | 7 | |
| other | leg twinge | Musculoskeletal and connective tissue disorders | Intervention Arm | 0 | 8 | |
| other | leg twinge | Musculoskeletal and connective tissue disorders | Placebo Arm | 1 | 7 | |
| other | diarrhea | Gastrointestinal disorders | Intervention Arm | 1 | 8 | |
| other | diarrhea | Gastrointestinal disorders | Placebo Arm | 2 | 7 | |
| other | abdominal pain | Gastrointestinal disorders | Intervention Arm | 0 | 8 | |
| other | abdominal pain | Gastrointestinal disorders | Placebo Arm | 1 | 7 | |
| other | tinnitus | Ear and labyrinth disorders | Intervention Arm | 0 | 8 | |
| other | tinnitus | Ear and labyrinth disorders | Placebo Arm | 1 | 7 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention Arm | ||
| Total, all-cause mortality | Placebo Arm | ||
| Total, other adverse events | Intervention Arm | 4 | 8 |
| Total, other adverse events | Placebo Arm | 4 | 7 |
| Total, serious adverse events | Intervention Arm | 1 | 8 |
| Total, serious adverse events | Placebo Arm | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention Arm vs Placebo Arm: Number of Participants With Increase in Investigator's Global Assessment Score | Trial comparisons |
| Intervention Arm vs Placebo Arm: Number of Participants With a Decrease in Vitiligo Area Scoring Index (VASI) Score | Trial comparisons |
| Intervention Arm vs Placebo Arm: Number of Participants With an Increase in Patient's Global Assessment Score | Trial comparisons |
| Intervention Arm vs Placebo Arm: Number of Participants Experiencing Toxicity From of High-dose Simvastatin . | Trial comparisons |
| Intervention Arm vs Placebo Arm: 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/NCT01517893
GET https://conductscience.org/api/trials/v1/NCT01517893/events?page=2