Trial Outcomes & Findings for Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam (NCT NCT00842153)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

58 participants

Primary outcome timeframe

Weeks 1, 2, and 4

Results posted on

2017-10-09

Participant Flow

A wash-out period of 2 to 8 weeks, the duration of which varied by specific medication, was required prior to Visit 1.

Participant milestones

Participant milestones
Measure	Olux-E Foam 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 Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Study STARTED	28	30
Overall Study COMPLETED	27	27
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Olux-E Foam 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 Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olux-E Foam n=28 Participants 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 n=30 Participants Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body	Total n=58 Participants Total of all reporting groups
Age, Continuous	54.2 Years STANDARD_DEVIATION 20.0 • n=5 Participants	47.2 Years STANDARD_DEVIATION 13.4 • n=7 Participants	50.6 Years STANDARD_DEVIATION 17.1 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants
Race/Ethnicity, Customized Black	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Other (not included above; including mixed race)	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 1, 2, and 4

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Olux-E Foam n=27 Participants 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 n=30 Participants Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 Week 1, n=26, 30	6 participants	2 participants
Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 Week 2, n=26, 30	19 participants	3 participants
Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 Week 4, n=27, 28	12 participants	2 participants

SECONDARY outcome

Timeframe: Weeks 1, 2, and 4

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Olux-E Foam n=27 Participants 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 n=30 Participants Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4 Week 1, n=26, 30	19 participants	6 participants
Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4 Week 2, n=26, 30	21 participants	9 participants
Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4 Week 4, n=27, 28	15 participants	8 participants

SECONDARY outcome

Timeframe: Week 2

Population: ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.

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.

Outcome measures

Outcome measures
Measure	Olux-E Foam n=26 Participants 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 n=30 Participants Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2	21 participants	17 participants

SECONDARY outcome

Timeframe: Week 2

Population: ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.

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.

Outcome measures

Outcome measures
Measure	Olux-E Foam n=26 Participants 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 n=30 Participants Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Number of Participants With an Erythema Score of 0 or 1 at Week 2	6 participants	1 participants

SECONDARY outcome

Timeframe: Week 2

Population: ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.

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.

Outcome measures

Outcome measures
Measure	Olux-E Foam n=26 Participants 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 n=30 Participants Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Number of Participants With a Scaling Score of 0 or 1 at Week 2	11 participants	5 participants

SECONDARY outcome

Timeframe: Week 2

Population: ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.

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.

Outcome measures

Outcome measures
Measure	Olux-E Foam n=26 Participants 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 n=30 Participants Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2	16 participants	4 participants

SECONDARY outcome

Timeframe: Week 2

Population: ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.

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.

Outcome measures

Outcome measures
Measure	Olux-E Foam n=26 Participants 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 n=30 Participants Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2	5 participants	1 participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 2

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Olux-E Foam n=25 Participants 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 n=25 Participants Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)	-30.5 Percent change in scores on a scale Standard Deviation 155.8	40.1 Percent change in scores on a scale Standard Deviation 442.0

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 2

Population: ITT Population

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 1 and Week 4

Population: 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.

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.