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Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam

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ClinicalTrials.gov Identifier: NCT00842153
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : January 30, 2012
Last Update Posted : October 9, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Clobetasol propionate foam
Drug: Vehicle foam
Enrollment 58
Recruitment Details  
Pre-assignment Details A wash-out period of 2 to 8 weeks, the duration of which varied by specific medication, was required prior to Visit 1.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Period Title: Overall Study
Started 28 30
Completed 27 27
Not Completed 1 3
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             1             2
Arm/Group Title Olux-E Foam Vehicle Foam Total
Hide Arm/Group Description Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body Total of all reporting groups
Overall Number of Baseline Participants 28 30 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 30 participants 58 participants
54.2  (20.0) 47.2  (13.4) 50.6  (17.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
Female
12
  42.9%
15
  50.0%
27
  46.6%
Male
16
  57.1%
15
  50.0%
31
  53.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
Caucasian 23 23 46
Black 1 0 1
Hispanic 0 2 2
Asian 2 3 5
Other (not included above; including mixed race) 2 2 4
1.Primary Outcome
Title Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4
Hide Description The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.
Time Frame Weeks 1, 2, and 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all enrolled participants. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 27 30
Measure Type: Number
Unit of Measure: participants
Week 1, n=26, 30 6 2
Week 2, n=26, 30 19 3
Week 4, n=27, 28 12 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olux-E Foam, Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1269
Comments P-value for Week 1
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olux-E Foam, Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value for Week 2
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olux-E Foam, Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0015
Comments P-value for Week 4
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4
Hide Description The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.
Time Frame Weeks 1, 2, and 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 27 30
Measure Type: Number
Unit of Measure: participants
Week 1, n=26, 30 19 6
Week 2, n=26, 30 21 9
Week 4, n=27, 28 15 8
3.Secondary Outcome
Title Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2
Hide Description Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 26 30
Measure Type: Number
Unit of Measure: participants
21 17
4.Secondary Outcome
Title Number of Participants With an Erythema Score of 0 or 1 at Week 2
Hide Description The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 26 30
Measure Type: Number
Unit of Measure: participants
6 1
5.Secondary Outcome
Title Number of Participants With a Scaling Score of 0 or 1 at Week 2
Hide Description The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 26 30
Measure Type: Number
Unit of Measure: participants
11 5
6.Secondary Outcome
Title Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2
Hide Description The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 26 30
Measure Type: Number
Unit of Measure: participants
16 4
7.Secondary Outcome
Title Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2
Hide Description Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 26 30
Measure Type: Number
Unit of Measure: participants
5 1
8.Secondary Outcome
Title Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)
Hide Description Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with “0=None” and the right side anchored with “10=Very Severe.” A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100.
Time Frame Baseline (Week 0) and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who returned for the visit specified (Week 2) and/or provided an assessment of pruritis were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Percent change in scores on a scale
-30.5  (155.8) 40.1  (442.0)
9.Secondary Outcome
Title Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected
Hide Description Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.
Time Frame Baseline (Week 0) and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4
Hide Description The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.
Time Frame Week 1 and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who returned for the visit specified (Week 1 and/or 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 27 30
Measure Type: Number
Unit of Measure: participants
Week 1, n=26, 30 6 2
Week 4, n=27, 28 12 2
11.Secondary Outcome
Title Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4
Hide Description Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.
Time Frame Baseline (Week 0) and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 28 30
Measure Type: Number
Unit of Measure: participants
Baseline (Week 0), n=28, 30 8 9
Week 4, n=27, 28 19 17
12.Secondary Outcome
Title Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4
Hide Description The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.
Time Frame Baseline (Week 0) and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for erythema were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 28 30
Measure Type: Number
Unit of Measure: participants
Baseline (Week 0), n=28, 30 0 0
Week 4, n=27, 28 6 1
13.Secondary Outcome
Title Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4
Hide Description The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.
Time Frame Baseline (Week 0) and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for scaling were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 28 30
Measure Type: Number
Unit of Measure: participants
Baseline (Week 0), n=28, 30 0 0
Week 4, n=27, 28 6 4
14.Secondary Outcome
Title Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4
Hide Description The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.
Time Frame Baseline (Week 0) and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for plaque thickness were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 28 30
Measure Type: Number
Unit of Measure: participants
Baseline (Week 0), n=28, 30 0 0
Week 4, n=27, 28 12 2
15.Secondary Outcome
Title Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4
Hide Description Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.
Time Frame Baseline (Week 0) and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for Subject Global Assessment were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 28 30
Measure Type: Number
Unit of Measure: participants
Baseline (Week 0), n=28, 30 0 0
Week 4, n=27, 28 7 1
16.Secondary Outcome
Title Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)
Hide Description Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with “0=None” and the right side anchored with “10=Very Severe.” A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100.
Time Frame Baseline (Week 0) and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 26 23
Mean (Standard Deviation)
Unit of Measure: Percent change in scores on a scale
-6.8  (213.5) -40.2  (67.4)
17.Secondary Outcome
Title Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected
Hide Description Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.
Time Frame Baseline (Week 0) and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description:
Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description One participant in the ITT Population was dispensed study drug but did not return after the Baseline visit; thus, this participant was not included in the analysis of serious adverse events (SAEs) or non-serious AEs.
 
Arm/Group Title Olux-E Foam Vehicle Foam
Hide Arm/Group Description Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
All-Cause Mortality
Olux-E Foam Vehicle Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Olux-E Foam Vehicle Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Olux-E Foam Vehicle Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   3/27 (11.11%)   6/30 (20.00%) 
General disorders     
Tooth Extraction Surgery  1  1/27 (3.70%)  0/30 (0.00%) 
Hemorrhoids  1  1/27 (3.70%)  0/30 (0.00%) 
Moderately Elevated Prostate-Specific Antigen (PSA)  1  0/27 (0.00%)  1/30 (3.33%) 
Infections and infestations     
Common Cold  1  1/27 (3.70%)  0/30 (0.00%) 
Bronchitis  1  0/27 (0.00%)  1/30 (3.33%) 
Gastrointestinal Virus  1  0/27 (0.00%)  1/30 (3.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Diagnosed Prostate Cancer  1  0/27 (0.00%)  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders     
Sinusitis  1  0/27 (0.00%)  1/30 (3.33%) 
Skin and subcutaneous tissue disorders     
Worsening Of Psoriasis, Upper Extremities  1  0/27 (0.00%)  1/30 (3.33%) 
Papular Dermatitis On Left Upper Abdomen  1  0/27 (0.00%)  1/30 (3.33%) 
Left Shin, Target Area Worse, Severe Itching/Oozing/Wheeping  1  0/27 (0.00%)  1/30 (3.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00842153     History of Changes
Other Study ID Numbers: OEF0701
First Submitted: February 11, 2009
First Posted: February 12, 2009
Results First Submitted: December 21, 2011
Results First Posted: January 30, 2012
Last Update Posted: October 9, 2017