Maintenance Effect of Clobex Shampoo on Participants With Moderate to Severe Scalp Psoriasis

Time to first relapse was defined as the duration between baseline of maintenance phase and the visit where the relapse occurred. The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS \>2.

Time frame: Baseline up to 24 Weeks

Population: ITT Population included the entire population who were enrolled and randomized (i.e., assigned a kit number).

Global severity score was evaluated on a scale of 0-4 and it was categorized as; Clear (score 0); no clinical signs or symptoms detected (hyperpigmentation or residual red coloration might be present), very mild (score 1); only very slight signs or symptoms detected (e.g., very fine scaling or slight erythema), mild (score 2); slight signs or symptoms detected (e.g., mild erythema and scaling, eventually associated to some barely detectable plaque elevation), moderate (score 3); moderate or clearly detectable signs or symptoms (e.g., definite redness with obvious scaling on a plaque that was elevated above skin level), severe (score 4); severe signs or symptoms detected (e.g., intense redness, profuse shedding, definite plaque thickness was most often present) where 0 indicates best and 4 indicates worst. Percentage of participants with GSS was reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF).

Time frame: Baseline, Weeks 2 and 4 LOCF

Population: ITT Population included the entire population who were enrolled and randomized. (i.e., assigned a kit number).

Individual sign scores of erythema (abnormal redness of skin), scaling (scales attached to the scalp), plaque thickening (a thickening or elevation of a circumscribed lesion or plaque) were evaluated on a scale of 0-4; 0= none , 1= mild , 2=moderate , 3= severe, 4= very severe, where 0 indicates best and 4 indicates worst. Percentage of participants with individual signs (erythema, scaling, and plaque thickening) scores were reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF).

Time frame: Baseline, Weeks 2 and 4 LOCF

Population: ITT Population included the entire population who were enrolled and randomized. (i.e., assigned a kit number).

Pruritus (itching sensation) score of were evaluated on a scale from 0 - 3 (0 = None \[no itching\], 1 = Mild \[slight itching\], not really bothersome), 2 = Moderate \[definite itching that is somewhat bothersome; without loss of sleep\], and 3 = severe \[intense itching that has caused pronounced discomfort; night rest interrupted and excoriations of the skin from scratching may be present\]) , where 0 indicates best and 3 indicates worst. Percentage of participants with pruritus score was reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF).

Time frame: Baseline, Weeks 2 and 4 LOCF

Population: ITT Population included the entire population who were enrolled and randomized. (i.e., assigned a kit number).

The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS \>2. Relapse was categorized into relapse or no relapse. Percentage of participants with relapse were reported.

Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24

Population: ITT worstcase population signifies participants who prematurely discontinued before the time of first relapse were considered as relapse at following visit. Here, number analyzed refer to participants evaluable for this outcome at given timepoints.

The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS \>2. Individual sign scores of erythema were evaluated on a scale of 0-4 (0= none, 1= mild, 2=moderate, 3= severe, 4= very severe), where 0 indicates best and 4 indicates worst. Percentage of participants with individual signs (erythema, scaling and plaque thickening) scores were reported. There were no participants in scaling category with 0 score.

Time frame: Baseline up to Week 24

Population: ITT Population included the entire population who were enrolled and randomized (i.e., assigned a kit number). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure.

Number of relapses of participants were categorized as 0; zero relapse, 1; one relapse, 2; two relapse, 3; three relapse, 4; two consecutive relapses. Percentage of participants with total number of relapses experienced during maintenance period was reported.

Time frame: Baseline up to Week 28

Population: ITT worstcase population signifies participants who prematurely discontinued before the time of first relapse were considered as relapse at following visit.

Pruritus (itching sensation) score of were evaluated on a scale from 0 - 3 (0 = None \[no itching\], 1 = Mild \[slight itching, not really bothersome\], 2 = Moderate \[definite itching that is somewhat bothersome; without loss of sleep\], and 3 = severe \[intense itching that has caused pronounced discomfort; night rest interrupted and excoriations of the skin from scratching may be present\]) , where 0 indicates best and 3 indicates worst. Percentage of participants with scalp psoriasis pruritus score at first relapse was reported.

Time frame: Baseline up to Week 24

Population: ITT worstcase population signifies participants who prematurely discontinued before the time of first relapse were considered as relapse at following visit. Overall number of participants analyzed refer to the participants evaluable for this outcome measure.