Trial Outcomes & Findings for Efficacy of Atorvastatin as Adjunctive Treatment for Chronic Plaque Type Psoriasis (NCT NCT02432040)

NCT ID: NCT02432040

Last Updated: 2015-11-23

Results Overview

Psoriasis Area and Severity Index involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - \<10%, 2 - 10-\<30%, 3 - 30-\<50%, 4 - 50-\<70%, 5 - 70-\<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 28 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2015-11-23

Participant Flow

The study was conducted from February 2013 to October 2013 at a dermatology out-patient clinic in a tertiary hospital in the Philippines. Patients diagnosed with mild to moderate chronic plaque type psoriasis were screened for eligibility.

Patients who were not newly diagnosed with psoriasis and already on medications were allowed to be enrolled into the study as long as they have been free of any systemic anti-psoriatic therapy for at least 2 months or free from topical steroids for at least 2 weeks.

Participant milestones

Measure	Atorvastatin Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia	Placebo Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Overall Study STARTED	14	14
Overall Study COMPLETED	6	8
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Measure	Atorvastatin Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia	Placebo Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Overall Study Lack of Efficacy	3	0
Overall Study Lost to Follow-up	4	5
Overall Study Physician Decision	1	1

Baseline Characteristics

Efficacy of Atorvastatin as Adjunctive Treatment for Chronic Plaque Type Psoriasis

Baseline characteristics by cohort

Measure	Atorvastatin n=14 Participants Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia	Placebo n=14 Participants Placebo tablets But patients are still asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most	Total n=28 Participants Total of all reporting groups
Age, Continuous	41.29 Years STANDARD_DEVIATION 11.38 • n=5 Participants	40.71 Years STANDARD_DEVIATION 12.00 • n=7 Participants	41 Years STANDARD_DEVIATION 11.48 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
PASI score	5.49 units on a scale STANDARD_DEVIATION 2.78 • n=5 Participants	5.63 units on a scale STANDARD_DEVIATION 2.52 • n=7 Participants	5.56 units on a scale STANDARD_DEVIATION 2.61 • n=5 Participants
Total cholesterol	193.02 mg/dL STANDARD_DEVIATION 34.85 • n=5 Participants	197.73 mg/dL STANDARD_DEVIATION 36.52 • n=7 Participants	195.37 mg/dL STANDARD_DEVIATION 35.11 • n=5 Participants
Triglycerides	126.73 mg/dL STANDARD_DEVIATION 45.71 • n=5 Participants	112.27 mg/dL STANDARD_DEVIATION 45.37 • n=7 Participants	119.50 mg/dL STANDARD_DEVIATION 45.29 • n=5 Participants
LDL-cholesterol	125.88 mg/dL STANDARD_DEVIATION 29.42 • n=5 Participants	129.49 mg/dL STANDARD_DEVIATION 29.11 • n=7 Participants	127.69 mg/dL STANDARD_DEVIATION 28.78 • n=5 Participants
HDL-cholesterol	46.13 mg/dL STANDARD_DEVIATION 12.68 • n=5 Participants	46.56 mg/dL STANDARD_DEVIATION 13.13 • n=7 Participants	46.34 mg/dL STANDARD_DEVIATION 12.67 • n=5 Participants
High-sensitivity C-reactive protein (hsCRP)	63.46 nmol/L STANDARD_DEVIATION 119.43 • n=5 Participants	39.62 nmol/L STANDARD_DEVIATION 44.67 • n=7 Participants	51.54 nmol/L STANDARD_DEVIATION 89.31 • n=5 Participants
DLQI score	11.50 units on a scale STANDARD_DEVIATION 6.04 • n=5 Participants	9.07 units on a scale STANDARD_DEVIATION 5.84 • n=7 Participants	10.29 units on a scale STANDARD_DEVIATION 5.96 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.

Psoriasis Area and Severity Index involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - <10%, 2 - 10-<30%, 3 - 30-<50%, 4 - 50-<70%, 5 - 70-<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.

Outcome measures

Measure	Atorvastatin n=11 Participants Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia	Placebo n=11 Participants Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Mean Gross Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline to the End of 6 Months	-2.15 units on a scale Standard Deviation 2.17	-1.69 units on a scale Standard Deviation 2.36

PRIMARY outcome

Timeframe: 6 months

Population: Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.

Percentage of patients in each arm who will achieve 50% reduction in PASI scores at the end of 6 months will be compared

Outcome measures

Measure	Atorvastatin n=11 Participants Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia	Placebo n=11 Participants Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Percentage of Patients Achieving PASI-50 in Each Arm at the End of 6 Months	27.3 percentage of participants	45.5 percentage of participants

SECONDARY outcome

Timeframe: Monthly from baseline to 6 months

Population: Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.

PASI scores were measured monthly and mean changes from baseline for each month for the whole 6-month duration of the study recorded.

Outcome measures

Measure	Atorvastatin n=11 Participants Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia	Placebo n=11 Participants Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Monthly Mean Changes in PASI Scores Mean change for the fifth month	-2.15 units on a scale Standard Deviation 2.16	-1.43 units on a scale Standard Deviation 2.59
Monthly Mean Changes in PASI Scores Mean change for the first month	-0.72 units on a scale Standard Deviation 0.63	-0.71 units on a scale Standard Deviation 0.88
Monthly Mean Changes in PASI Scores Mean change for the second month	-1.67 units on a scale Standard Deviation 1.99	-0.69 units on a scale Standard Deviation 1.00
Monthly Mean Changes in PASI Scores Mean change for the third month	-2.19 units on a scale Standard Deviation 2.27	-1.16 units on a scale Standard Deviation 1.52
Monthly Mean Changes in PASI Scores Mean change for the fourth month	-2.10 units on a scale Standard Deviation 2.20	-1.13 units on a scale Standard Deviation 2.05
Monthly Mean Changes in PASI Scores Mean change for the sixth month	-2.15 units on a scale Standard Deviation 2.17	-1.69 units on a scale Standard Deviation 2.36

SECONDARY outcome

Timeframe: 3 months

Population: Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.

PASI-50 means at least a 50% reduction from baseline PASI score

Outcome measures

Measure	Atorvastatin n=11 Participants Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia	Placebo n=11 Participants Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Percentage of Patients Achieving PASI-50 at the End of 3 Months	36.4 percentage of participants	18.2 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of patients analyzed were the ones who completed the study. Intention-to-treat analysis was done.

Outcome measures

Measure	Atorvastatin n=6 Participants Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia	Placebo n=8 Participants Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Mean Change in Dermatology Life Quality Index (DLQI) Scores After 6 Months	-6.5 units on a scale Standard Deviation 5.58	-2.13 units on a scale Standard Deviation 6.56

SECONDARY outcome

Timeframe: 6 months

Population: Intention-to-treat analysis was done. Patients who completed the study were included.

Outcome measures

Measure	Atorvastatin n=6 Participants Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia	Placebo n=8 Participants Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Mean Change in Lipid Profile Levels Total cholesterol	-35.39 mg/dL Standard Deviation 47.94	-38.32 mg/dL Standard Deviation 74.72
Mean Change in Lipid Profile Levels Triglycerides	-17.55 mg/dL Standard Deviation 49.93	-5.12 mg/dL Standard Deviation 39.35
Mean Change in Lipid Profile Levels LDL Cholesterol	-45.18 mg/dL Standard Deviation 24.28	-13.48 mg/dL Standard Deviation 24.02
Mean Change in Lipid Profile Levels HDL Cholesterol	3.15 mg/dL Standard Deviation 5.95	-0.69 mg/dL Standard Deviation 11.00

SECONDARY outcome

Timeframe: 6 months

Population: Intention-to-treat analysis was done. Patients who completed the study were included since they were the only ones who had another hsCRP reading after baseline.

Outcome measures

Measure	Atorvastatin n=6 Participants Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia	Placebo n=8 Participants Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Mean Change in hsCRP Levels	-7.58 nmol/L Standard Deviation 32.92	-5.14 nmol/L Standard Deviation 28.34

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Atorvastatin n=14 Participants Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia	Placebo n=14 Participants Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Adverse Events	2 participants	0 participants

Adverse Events

Atorvastatin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

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	Atorvastatin n=14 participants at risk Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia	Placebo n=14 participants at risk Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Hepatobiliary disorders Elevation in liver enzymes	7.1% 1/14 • Number of events 2	0.00% 0/14
Musculoskeletal and connective tissue disorders Muscle aches	7.1% 1/14 • Number of events 1	0.00% 0/14

Additional Information

Dr. Sharlene Chua

University of the Philippines - Philippine General Hospital Section of Dermatology

Phone: 2418118

Email: sharlene_chua@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place