Trial Outcomes & Findings for Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis (NCT NCT00988637)
NCT ID: NCT00988637
Last Updated: 2022-08-01
Results Overview
Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
COMPLETED
PHASE4
138 participants
Baseline to Week 4
2022-08-01
Participant Flow
Dates of recruitment period: First subject was enrolled on October 26, 2009 and the last subject was enrolled on January 28, 2010.
Wash-out period up to baseline is 30 days for any steroid containing medication, dovonex, anthralin, tar and/or ultraviolet B (UVB) treatment; 12 weeks for corticosteroids, biologics and/or psoralen + ultraviolet A (PUVA) treatment.
Participant milestones
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
68
|
|
Overall Study
COMPLETED
|
67
|
65
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
non-compliance with study drug
|
0
|
1
|
Baseline Characteristics
Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 14.03 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 14.43 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 14.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Outcome measures
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4
|
14 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Baseline to week 2Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 based on the Overall Disease Severity (ODS), dichotomized scale from Baseline to Week 2. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Outcome measures
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2
|
9 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: ITT (Intent to Treat); LOCF (Last Observation Carried Forward)
Number of participants in each category of the Global Assessment of Improvement (GAI) Scale from Baseline to Week 4. The Global Assessment of Improvement is evaluated on a scale from -1 to 4 (-1 = Symptoms worse, 0 = No change, 1 = Minimal Improvement, 2 = Definite Improvement, 3 = Considerable Improvement and 4 = Clearing) with -1 being worst and 4 being best.
Outcome measures
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4
Symptoms worse (-1)
|
1 participants
|
0 participants
|
|
Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4
No change (0)
|
2 participants
|
6 participants
|
|
Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4
Minimal Improvement (1)
|
9 participants
|
6 participants
|
|
Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4
Definite Improvement (2)
|
25 participants
|
10 participants
|
|
Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4
Considerable Improvement (3)
|
19 participants
|
18 participants
|
|
Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4
Clearing (4)
|
13 participants
|
25 participants
|
|
Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4
Missing
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: ITT (Intent to Treat; LOCF (Last Observation Carried Forward)
Number of participants with a decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4. Signs of Psoriasis (Erythema) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe with 0 being best and 4 being worst.
Outcome measures
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4
Clear (0)
|
5 participants
|
4 participants
|
|
Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4
Almost Clear (1)
|
6 participants
|
15 participants
|
|
Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4
Mild (2)
|
31 participants
|
32 participants
|
|
Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4
Moderate (3)
|
28 participants
|
17 participants
|
|
Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4
Severe/Very Severe (4)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: ITT (Intent to Treat); LOCF (Last Observation Carried Forward)
Number of participants with decrease in Signs of Psoriasis (Scaling) scores from Baseline to Week 4. Signs of Psoriasis (Scaling) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Outcome measures
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4
Clear (0)
|
12 participants
|
20 participants
|
|
Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4
Almost Clear (1)
|
24 participants
|
20 participants
|
|
Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4
Mild (2)
|
28 participants
|
23 participants
|
|
Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4
Moderate (3)
|
6 participants
|
5 participants
|
|
Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4
Severe (4)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: ITT (Intent to Treat); LOCF (Last Observation Carried Forward)
Number of participants with decrease in Signs of Psoriasis (Plaque Elevation) scores from Baseline to Week 4. Signs of Psoriasis (Plaque Elevation) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
Outcome measures
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4
Clear (0)
|
6 participants
|
11 participants
|
|
Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4
Almost Clear (1)
|
15 participants
|
24 participants
|
|
Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4
Mild (2)
|
33 participants
|
26 participants
|
|
Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4
Moderate (3)
|
16 participants
|
7 participants
|
|
Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4
Severe/Very Severe (4)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: ITT (Intent to Treat); LOCF (Last Observation Carried Forward)
Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4
Outcome measures
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4
|
-33.3 Percent change
Standard Deviation 31.85
|
-50.0 Percent change
Standard Deviation 30.15
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: ITT (Intent to Treat)
Mean change from baseline scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) from Baseline to Week 4. The Koo-Menter Psoriasis Index is a questionnaire with 12 questions that can be used to assess the effect that psoriasis has on a patient's overall quality of life. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst.
Outcome measures
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4
|
-24.8 Units on a scale
Standard Deviation 22.81
|
-27.5 Units on a scale
Standard Deviation 27.10
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT (Intent to Treat)
Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "The treatment program was easy to follow" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Outcome measures
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "The Treatment Program Was Easy to Follow" at Week 4
Strongly agree
|
61 participants
|
59 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "The Treatment Program Was Easy to Follow" at Week 4
Moderately agree
|
2 participants
|
8 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "The Treatment Program Was Easy to Follow" at Week 4
No opinion
|
2 participants
|
0 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "The Treatment Program Was Easy to Follow" at Week 4
Moderately disagree
|
2 participants
|
0 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "The Treatment Program Was Easy to Follow" at Week 4
Strongly disagree
|
0 participants
|
0 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "The Treatment Program Was Easy to Follow" at Week 4
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 4Population: ITT (Intent to Treat)
Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I am Satisfied with my Appearance" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Outcome measures
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With my Appearance" at Week 4
Strongly agree
|
10 participants
|
25 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With my Appearance" at Week 4
Moderately agree
|
39 participants
|
32 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With my Appearance" at Week 4
No opinion
|
6 participants
|
4 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With my Appearance" at Week 4
Moderately disagree
|
9 participants
|
5 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With my Appearance" at Week 4
Strongly disagree
|
3 participants
|
1 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With my Appearance" at Week 4
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 4Population: ITT (Intent to Treat)
Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I am satisfied with the results of this treatment program" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Outcome measures
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With the Results of This Treatment Program" at Week 4
Strongly agree
|
23 participants
|
42 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With the Results of This Treatment Program" at Week 4
Moderately agree
|
35 participants
|
20 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With the Results of This Treatment Program" at Week 4
No opinion
|
5 participants
|
1 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With the Results of This Treatment Program" at Week 4
Moderately disagree
|
3 participants
|
4 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With the Results of This Treatment Program" at Week 4
Strongly disagree
|
1 participants
|
0 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With the Results of This Treatment Program" at Week 4
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 4Population: ITT (Intent to Treat)
Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question "I would use this treatment program again if recommended by the dermatologist" at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree.
Outcome measures
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I Would Use This Treatment Program Again if Recommended by the Dermatologist" at Week 4
Strongly agree
|
37 participants
|
50 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I Would Use This Treatment Program Again if Recommended by the Dermatologist" at Week 4
Moderately agree
|
21 participants
|
16 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I Would Use This Treatment Program Again if Recommended by the Dermatologist" at Week 4
No opinion
|
3 participants
|
0 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I Would Use This Treatment Program Again if Recommended by the Dermatologist" at Week 4
Moderately disagree
|
2 participants
|
1 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I Would Use This Treatment Program Again if Recommended by the Dermatologist" at Week 4
Strongly disagree
|
4 participants
|
0 participants
|
|
Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I Would Use This Treatment Program Again if Recommended by the Dermatologist" at Week 4
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Safety
Number of participants with Tolerability Assessments resulting in Adverse Events from baseline to week 4. Tolerability assessments (Pruritus, telangiectasias, and stinging/burning) are evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 3 being worst. Skin atrophy and folliculitis are evaluated as absent or present. Changes in tolerability assessments that require a dose modification or concomitant medications/therapy are recorded as adverse events.
Outcome measures
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 Participants
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 Participants
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4
|
4 participants
|
2 participants
|
Adverse Events
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)
n=70 participants at risk
Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
|
Clobex® Spray (Morning) and Vectical® Ointment (Evening)
n=68 participants at risk
Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
4/70 • Number of events 4 • 4 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), if applicable.
|
0.00%
0/68 • 4 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), if applicable.
|
Additional Information
Ronald W. Gottschalk, MD / Medical Dierctor
Galderma Laboratories, L.P.
Results disclosure agreements
- Principal investigator is a sponsor employee The principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.
- Publication restrictions are in place
Restriction type: OTHER