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Trial record 83 of 272 for:    Betamethasone

Efficacy of Atorvastatin as Adjunctive Treatment for Chronic Plaque Type Psoriasis

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ClinicalTrials.gov Identifier: NCT02432040
Recruitment Status : Completed
First Posted : May 1, 2015
Results First Posted : November 23, 2015
Last Update Posted : November 23, 2015
Sponsor:
Information provided by (Responsible Party):
Sharlene Chua, Philippine Dermatological Society

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Atorvastatin
Drug: Placebo
Enrollment 28
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description

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 tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Period Title: Overall Study
Started 14 14
Completed 6 8
Not Completed 8 6
Reason Not Completed
Lack of Efficacy             3             0
Lost to Follow-up             4             5
Physician Decision             1             1
Arm/Group Title Atorvastatin Placebo Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
41.29  (11.38) 40.71  (12.00) 41  (11.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
7
  50.0%
10
  71.4%
17
  60.7%
Male
7
  50.0%
4
  28.6%
11
  39.3%
PASI score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 14 participants 14 participants 28 participants
5.49  (2.78) 5.63  (2.52) 5.56  (2.61)
[1]
Measure Description: 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.
Total cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 14 participants 14 participants 28 participants
193.02  (34.85) 197.73  (36.52) 195.37  (35.11)
Triglycerides  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 14 participants 14 participants 28 participants
126.73  (45.71) 112.27  (45.37) 119.50  (45.29)
LDL-cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 14 participants 14 participants 28 participants
125.88  (29.42) 129.49  (29.11) 127.69  (28.78)
HDL-cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 14 participants 14 participants 28 participants
46.13  (12.68) 46.56  (13.13) 46.34  (12.67)
High-sensitivity C-reactive protein (hsCRP)  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 14 participants 14 participants 28 participants
63.46  (119.43) 39.62  (44.67) 51.54  (89.31)
DLQI score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 14 participants 14 participants 28 participants
11.50  (6.04) 9.07  (5.84) 10.29  (5.96)
[1]
Measure Description: Dermatology Life Quality Index (DLQI) is a 10-item self-administered questionnaire designed to evaluate the quality of life of patients with skin diseases. Items are scored on a 4-point scale, with higher scores indicating a greater impairment in the quality of life. The total score is interpreted as follows: 0-1=no effect on patient’s life, 2-5=mild effect, 6-10=moderate effect, 11-20=very large effect, and 21-30=extremely large effect.
1.Primary Outcome
Title Mean Gross Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline to the End of 6 Months
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description:

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 tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.15  (2.17) -1.69  (2.36)
2.Primary Outcome
Title Percentage of Patients Achieving PASI-50 in Each Arm at the End of 6 Months
Hide Description Percentage of patients in each arm who will achieve 50% reduction in PASI scores at the end of 6 months will be compared
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description:

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 tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Overall Number of Participants Analyzed 11 11
Measure Type: Number
Unit of Measure: percentage of participants
27.3 45.5
3.Secondary Outcome
Title Monthly Mean Changes in PASI Scores
Hide Description PASI scores were measured monthly and mean changes from baseline for each month for the whole 6-month duration of the study recorded.
Time Frame Monthly from baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description:

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 tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mean change for the first month -0.72  (0.63) -0.71  (0.88)
Mean change for the second month -1.67  (1.99) -0.69  (1.00)
Mean change for the third month -2.19  (2.27) -1.16  (1.52)
Mean change for the fourth month -2.10  (2.20) -1.13  (2.05)
Mean change for the fifth month -2.15  (2.16) -1.43  (2.59)
Mean change for the sixth month -2.15  (2.17) -1.69  (2.36)
4.Secondary Outcome
Title Percentage of Patients Achieving PASI-50 at the End of 3 Months
Hide Description PASI-50 means at least a 50% reduction from baseline PASI score
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description:

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 tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Overall Number of Participants Analyzed 11 11
Measure Type: Number
Unit of Measure: percentage of participants
36.4 18.2
5.Secondary Outcome
Title Mean Change in Dermatology Life Quality Index (DLQI) Scores After 6 Months
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients analyzed were the ones who completed the study. Intention-to-treat analysis was done.
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description:

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 tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.5  (5.58) -2.13  (6.56)
6.Secondary Outcome
Title Mean Change in Lipid Profile Levels
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat analysis was done. Patients who completed the study were included.
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description:

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 tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: mg/dL
Total cholesterol -35.39  (47.94) -38.32  (74.72)
Triglycerides -17.55  (49.93) -5.12  (39.35)
LDL Cholesterol -45.18  (24.28) -13.48  (24.02)
HDL Cholesterol 3.15  (5.95) -0.69  (11.00)
7.Secondary Outcome
Title Mean Change in hsCRP Levels
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description:

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 tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: nmol/L
-7.58  (32.92) -5.14  (28.34)
8.Secondary Outcome
Title Adverse Events
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description:

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 tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: participants
2 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atorvastatin Placebo
Hide Arm/Group Description

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 tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
All-Cause Mortality
Atorvastatin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Atorvastatin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atorvastatin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/14 (14.29%)      0/14 (0.00%)    
Hepatobiliary disorders     
Elevation in liver enzymes   1/14 (7.14%)  2 0/14 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle aches *  1/14 (7.14%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sharlene Chua
Organization: University of the Philippines - Philippine General Hospital Section of Dermatology
Phone: 2418118
EMail: sharlene_chua@yahoo.com
Layout table for additonal information
Responsible Party: Sharlene Chua, Philippine Dermatological Society
ClinicalTrials.gov Identifier: NCT02432040     History of Changes
Other Study ID Numbers: PDS_PGH_2013_002
First Submitted: April 28, 2015
First Posted: May 1, 2015
Results First Submitted: May 2, 2015
Results First Posted: November 23, 2015
Last Update Posted: November 23, 2015