Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00988637
• Collaborator: (none)
• Enrollment: 138
• Locations: 6
• Arms: 2
• Duration (Months): 5
• Patients Per Site: 23
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate) Spray 0.05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one of two different regimens:

1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray treatment twice daily on weekends (Sat - Sun) for 28 days

2. Clobex® Spray once each morning and Vectical™ Ointment once each evening for 28 days

Condition or Disease	Intervention/Treatment	Phase
Plaque Psoriasis	Drug: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen; Drug: Clobex® Spray morning and Vectical™ Ointment evening regimen	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: An Open-label, Multi-center, Randomized, Evaluator-Blinded Study to Evaluate the Safety and Efficacy of Two Treatment Regimens Involving Vectical™ (Calcitriol) Ointment 3 µg/g and Clobex® (Clobetasol Propionate) Spray, 0.05% in the Treatment of Moderate Plaque Psoriasis
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: 1) Vectical™ Ointment and Clobex® Spray Vectical™ Ointment weekdays & Clobex® Spray weekends regimen	Drug: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen; Vectical™ Ointment 3 µg/g, topical, apply twice daily on weekdays (Mon-Fri) and Clobex® Spray 0.05% twice daily on weekends (Sat-Sun) for 28 days; Other Names: calcitriol ointment 3µg/g and clobetasol propionate spray 0.05%
Other: 2) Clobex® Spray and Vectical™ Ointment Clobex® Spray morning and Vectical™ Ointment evening regimen	Drug: Clobex® Spray morning and Vectical™ Ointment evening regimen; Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days; Other Names: clobetasol propionate spray 0.05% and calcitriol ointment 3 µg/g

Outcome Measures

Primary Outcome Measures

1. 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 [Baseline to Week 4]

   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.

Secondary Outcome Measures

1. 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 [Baseline to week 2]

   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.

2. Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4 [Baseline to Week 4]

   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.

3. Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4 [Baseline to Week 4]

   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.

4. Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4 [Baseline to Week 4]

   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.

5. Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4 [Baseline to Week 4]

   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.

6. Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4 [Baseline to Week 4]

   Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4

7. Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4 [Baseline to Week 4]

   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.

8. 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 [Baseline and Week 4]

   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.

9. 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 [Week 4]

   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.

10. 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 [Week 4]

    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.

11. 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 [Week 4]

    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.

12. Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4 [Baseline to Week 4]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female subjects aged 18 to 80 years inclusive

• Subjects with an Overall Disease Severity of 3 (moderate)

• Subjects with 3% - 10% treatable BSA (Body Surface Area) excluding scalp, face, groin, axillae and/or other intertriginous areas

• For concurrent medications, type and dose must have been stable for at least 3 months prior to study entry and not expected to change during the study. Subjects receiving treatment with beta-blockers or lithium, whose dose has been stable for at lest 6 months and who have shown no worsening of their psoriasis, may be included in the study, at the discretion of the investigator

Exclusion Criteria:

• Subjects with intakes of more than 2,000 IU/day (50 mcg/day) of vitamin D (tolerable upper intake level) and/or more than 1,000 mg/day of calcium

• Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas

• Subjects with a wash-out period for topical treatment less than 30 days (Any steroid containing medication, dovonex, anthralin, tar and/or UVB treatment)

• Subjects with a wash-out period for systemic treatment less than 12 weeks (corticosteroids, biologics and/or PUVA treatment; Examples of these therapies include, but are not limited to PUVA, Soriatane, Cyclosporine, Hydroxyurea, Mycophenolate mofetil, Sulfasalazine, Azathioprine, Alefacept, Efalizumab, Adalimumab, Etanercept, Infliximab, Rituximab, and Methotrexate)

• Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis

• Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology Research Associates	Los Angeles	California	United States	90045
2	Therapeutics Clinical Research	San Diego	California	United States	92123
3	Hudson Dermatology	Evansville	Indiana	United States	47714
4	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
5	Baylor Research Institute Dermatology Research	Dallas	Texas	United States	75246
6	Probity Medical Research	Waterloo	Ontario	Canada	N2J1C4

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Ronald W Gottschalk, MD, Galderma R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT00988637
• Other Study ID Numbers: US10144
• First Posted: Oct 2, 2009
• Last Update Posted: Aug 1, 2022
• Last Verified: Sep 1, 2012

• Additional relevant MeSH terms: Psoriasis; Calcitriol; Clobetasol

Study Results

Participant Flow

Recruitment Details	Dates of recruitment period: First subject was enrolled on October 26, 2009 and the last subject was enrolled on January 28, 2010.
Pre-assignment Detail	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.

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Period Title: Overall Study
STARTED	70	68
COMPLETED	67	65
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)	Total
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen	Total of all reporting groups
Overall Participants	70	68	138
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.4 (14.03)	44.5 (14.43)	45.4 (14.21)
Sex: Female, Male (Count of Participants)
Female	27 38.6%	24 35.3%	51 37%
Male	43 61.4%	44 64.7%	87 63%

Outcome Measures

1. Primary Outcome

Title	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
Description	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.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Measure Participants	70	68
Number [participants]	14 20%	28 41.2%

2. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline to week 2

Outcome Measure Data

Analysis Population Description

ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Measure Participants	70	68
Number [participants]	9 12.9%	14 20.6%

3. Secondary Outcome

Title	Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4
Description	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.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

ITT (Intent to Treat); LOCF (Last Observation Carried Forward)

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Measure Participants	70	68
Symptoms worse (-1)	1 1.4%	0 0%
No change (0)	2 2.9%	6 8.8%
Minimal Improvement (1)	9 12.9%	6 8.8%
Definite Improvement (2)	25 35.7%	10 14.7%
Considerable Improvement (3)	19 27.1%	18 26.5%
Clearing (4)	13 18.6%	25 36.8%
Missing	1 1.4%	3 4.4%

4. Secondary Outcome

Title	Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4
Description	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.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

ITT (Intent to Treat; LOCF (Last Observation Carried Forward)

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Measure Participants	70	68
Clear (0)	5 7.1%	4 5.9%
Almost Clear (1)	6 8.6%	15 22.1%
Mild (2)	31 44.3%	32 47.1%
Moderate (3)	28 40%	17 25%
Severe/Very Severe (4)	0 0%	0 0%

5. Secondary Outcome

Title	Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4
Description	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.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

ITT (Intent to Treat); LOCF (Last Observation Carried Forward)

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Measure Participants	70	68
Clear (0)	12 17.1%	20 29.4%
Almost Clear (1)	24 34.3%	20 29.4%
Mild (2)	28 40%	23 33.8%
Moderate (3)	6 8.6%	5 7.4%
Severe (4)	0 0%	0 0%

6. Secondary Outcome

Title	Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4
Description	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.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

ITT (Intent to Treat); LOCF (Last Observation Carried Forward)

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Measure Participants	70	68
Clear (0)	6 8.6%	11 16.2%
Almost Clear (1)	15 21.4%	24 35.3%
Mild (2)	33 47.1%	26 38.2%
Moderate (3)	16 22.9%	7 10.3%
Severe/Very Severe (4)	0 0%	0 0%

7. Secondary Outcome

Title	Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4
Description	Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

ITT (Intent to Treat); LOCF (Last Observation Carried Forward)

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Measure Participants	70	68
Median (Standard Deviation) [Percent change]	-33.3 (31.85)	-50.0 (30.15)

8. Secondary Outcome

Title	Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4
Description	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.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

ITT (Intent to Treat)

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Measure Participants	70	68
Mean (Standard Deviation) [Units on a scale]	-24.8 (22.81)	-27.5 (27.10)

9. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

ITT (Intent to Treat)

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Measure Participants	70	68
Strongly agree	61 87.1%	59 86.8%
Moderately agree	2 2.9%	8 11.8%
No opinion	2 2.9%	0 0%
Moderately disagree	2 2.9%	0 0%
Strongly disagree	0 0%	0 0%
Missing	3 4.3%	1 1.5%

10. Secondary Outcome

Title	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
Description	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.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

ITT (Intent to Treat)

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Measure Participants	70	68
Strongly agree	10 14.3%	25 36.8%
Moderately agree	39 55.7%	32 47.1%
No opinion	6 8.6%	4 5.9%
Moderately disagree	9 12.9%	5 7.4%
Strongly disagree	3 4.3%	1 1.5%
Missing	3 4.3%	1 1.5%

11. Secondary Outcome

Title	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
Description	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.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

ITT (Intent to Treat)

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Measure Participants	70	68
Strongly agree	23 32.9%	42 61.8%
Moderately agree	35 50%	20 29.4%
No opinion	5 7.1%	1 1.5%
Moderately disagree	3 4.3%	4 5.9%
Strongly disagree	1 1.4%	0 0%
Missing	3 4.3%	1 1.5%

12. Secondary Outcome

Title	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
Description	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.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

ITT (Intent to Treat)

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Measure Participants	70	68
Strongly agree	37 52.9%	50 73.5%
Moderately agree	21 30%	16 23.5%
No opinion	3 4.3%	0 0%
Moderately disagree	2 2.9%	1 1.5%
Strongly disagree	4 5.7%	0 0%
Missing	3 4.3%	1 1.5%

13. Secondary Outcome

Title	Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4
Description	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.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)	Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
Measure Participants	70	68
Number [participants]	4 5.7%	2 2.9%

Adverse Events

Time Frame	4 weeks
Adverse Event Reporting Description	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.
Arm/Group Title	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)		Clobex® Spray (Morning) and Vectical® Ointment (Evening)
Arm/Group Description	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, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
All Cause Mortality
	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)		Clobex® Spray (Morning) and Vectical® Ointment (Evening)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)		Clobex® Spray (Morning) and Vectical® Ointment (Evening)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/68 (0%)
Other (Not Including Serious) Adverse Events
	Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)		Clobex® Spray (Morning) and Vectical® Ointment (Evening)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/70 (5.7%)		0/68 (0%)
Infections and infestations
Upper respiratory tract infection	4/70 (5.7%)	4	0/68 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.