Trial Outcomes & Findings for Maintenance Effect of Clobex Shampoo on Participants With Moderate to Severe Scalp Psoriasis (NCT NCT00400725)

Last Updated: 2023-07-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

288 participants

Primary outcome timeframe

Baseline up to 24 Weeks

Results posted on

2023-07-11

Participant Flow

The study was conducted at 12 sites in Canada from 29 September 2006 (first participant first visit) to 20 August 2007 (last participant last visit).

A total of 288 participants were enrolled in initial phase of the study, of which 225 participants were eligible to enter maintenance phase after completion of initial phase. Out of 225 eligible participants, only 217 participants (as 8 participants withdrew consent) were randomized and received treatment in the maintenance phase either in Clobetasol Propionate Shampoo group or Vehicle group.

Participant milestones

Participant milestones
Measure	Initial Phase:- Clobex® Shampoo In initial open-label phase, participants were applied Clobetasol Propionate shampoo 0.05 percent (%) weight by weight (W/W) topically to the scalp once daily (twice a week) for 4 weeks (weekly dose was not more than 50 grams \[50 Milliliter\]).	Maintenance Phase: Clobex® Shampoo In maintenance double-blind phase, participants presented with a good efficacy (Global severity score \[GSS\] less than or equal to \[\<=\] 2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05 percent (%) weight by weight (W/W) twice weekly up to 6 months (wherein weekly dose were not exceeded beyond 50 grams \[50 milliliter\]). In case of relapse (that is \[i.e.\], GSS greater than \[\>\] 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05%. After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).	Maintenance Phase:Clobex® Vehicle Shampoo In maintenance double-blind phase, participants presented with a good efficacy (Global severity score \[GSS\] \<= 2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose were not exceeded beyond 50 grams \[50 milliliter\]). In case of relapse (that is \[i.e.\], GSS \[greater than\] \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05 percent (%) weight by weight (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).
Initial Phase (up to 4 Weeks) STARTED	288	0	0
Initial Phase (up to 4 Weeks) COMPLETED	271	0	0
Initial Phase (up to 4 Weeks) NOT COMPLETED	17	0	0
Maintenance Phase (up to 6 Months) STARTED	0	106	111
Maintenance Phase (up to 6 Months) COMPLETED	0	90	82
Maintenance Phase (up to 6 Months) NOT COMPLETED	0	16	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Initial Phase:- Clobex® Shampoo In initial open-label phase, participants were applied Clobetasol Propionate shampoo 0.05 percent (%) weight by weight (W/W) topically to the scalp once daily (twice a week) for 4 weeks (weekly dose was not more than 50 grams \[50 Milliliter\]).	Maintenance Phase: Clobex® Shampoo In maintenance double-blind phase, participants presented with a good efficacy (Global severity score \[GSS\] less than or equal to \[\<=\] 2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05 percent (%) weight by weight (W/W) twice weekly up to 6 months (wherein weekly dose were not exceeded beyond 50 grams \[50 milliliter\]). In case of relapse (that is \[i.e.\], GSS greater than \[\>\] 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05%. After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).	Maintenance Phase:Clobex® Vehicle Shampoo In maintenance double-blind phase, participants presented with a good efficacy (Global severity score \[GSS\] \<= 2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose were not exceeded beyond 50 grams \[50 milliliter\]). In case of relapse (that is \[i.e.\], GSS \[greater than\] \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05 percent (%) weight by weight (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).
Initial Phase (up to 4 Weeks) Adverse Event	1	0	0
Initial Phase (up to 4 Weeks) Withdrawal by Subject	14	0	0
Initial Phase (up to 4 Weeks) Lost to Follow-up	1	0	0
Initial Phase (up to 4 Weeks) Other	1	0	0
Maintenance Phase (up to 6 Months) Lack of Efficacy	0	1	0
Maintenance Phase (up to 6 Months) Adverse Event	0	2	4
Maintenance Phase (up to 6 Months) Withdrawal by Subject	0	11	21
Maintenance Phase (up to 6 Months) Lost to Follow-up	0	1	2
Maintenance Phase (up to 6 Months) Other	0	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=288 Participants In initial open-label phase, participants were applied Clobetasol Propionate shampoo 0.05% topically to the scalp once daily (twice a week) for 4 weeks (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In maintenance double-blind phase, participants presented with a good efficacy (GSS \<= 2) in initial phase were randomized to apply Clobetasol Propionate Shampoo 0.05% (W/W) or Clobex® Vehicle Shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05%. After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).
Age, Continuous	50.4 years STANDARD_DEVIATION 16.1 • n=5 Participants
Sex: Female, Male Female	166 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	265 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	13 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 24 Weeks

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

Outcome measures

Outcome measures
Measure	Maintenance Phase: Clobex® Shampoo n=106 Participants In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05% (W/W) twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).	Maintenance Phase: Clobex® Vehicle Shampoo n=111 Participants In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).
Maintenance Phase: Time to First Relapse	93.5 days Standard Error 6.5	56.8 days Standard Error 4.7

SECONDARY outcome

Timeframe: Baseline, Weeks 2 and 4 LOCF

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).

Outcome measures

Outcome measures
Measure	Maintenance Phase: Clobex® Shampoo n=288 Participants In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05% (W/W) twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).	Maintenance Phase: Clobex® Vehicle Shampoo In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).
Initial Phase: Percentage of Participants With Global Severity Scores Baseline: Score 2 (Mild)	0 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Baseline: Score 4 (Severe)	41.7 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Week 2-LOCF: Score 0 (Clear)	2.4 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Week 2-LOCF: Score 1 (Very mild)	10.1 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Week 2-LOCF: Score 2 (Mild)	35.4 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Week 2-LOCF: Score 3 (Moderate)	43.1 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Week 2-LOCF: Score 4 (Severe)	9.0 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Week 4-LOCF: Score 1 (Very mild)	25.3 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Week 4-LOCF: Score 2 (Mild)	45.1 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Week 4-LOCF: Score 3 (Moderate)	18.4 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Week 4-LOCF: Score 4 (Severe)	3.5 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Baseline: Score 0 (Clear)	0 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Baseline: Score 1 (Very mild)	0 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Baseline: Score 3 (Moderate)	58.3 percentage of participants	—
Initial Phase: Percentage of Participants With Global Severity Scores Week 4-LOCF: Score 0 (Clear)	7.6 percentage of participants	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Maintenance Phase: Clobex® Shampoo n=288 Participants In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05% (W/W) twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).	Maintenance Phase: Clobex® Vehicle Shampoo In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).
Initial Phase: Percentage of Participants With Pruritus Scores Baseline: Score 0 (None)	3.8 percentage of participants	—
Initial Phase: Percentage of Participants With Pruritus Scores Baseline: Score 1 (Mild)	20.8 percentage of participants	—
Initial Phase: Percentage of Participants With Pruritus Scores Baseline: Score 2 (Moderate)	51.7 percentage of participants	—
Initial Phase: Percentage of Participants With Pruritus Scores Baseline: Score 3 (Severe)	23.6 percentage of participants	—
Initial Phase: Percentage of Participants With Pruritus Scores Week 2- LOCF: Score 0 (None)	19.8 percentage of participants	—
Initial Phase: Percentage of Participants With Pruritus Scores Week 2- LOCF: Score 2 (Moderate)	23.6 percentage of participants	—
Initial Phase: Percentage of Participants With Pruritus Scores Week 2- LOCF: Score 3 (Severe)	3.1 percentage of participants	—
Initial Phase: Percentage of Participants With Pruritus Scores Week 4- LOCF: Score 0 (None)	35.4 percentage of participants	—
Initial Phase: Percentage of Participants With Pruritus Scores Week 4- LOCF: Score 1 (Mild)	47.6 percentage of participants	—
Initial Phase: Percentage of Participants With Pruritus Scores Week 4- LOCF: Score 2 (Moderate)	15.6 percentage of participants	—
Initial Phase: Percentage of Participants With Pruritus Scores Week 4- LOCF: Score 3 (Severe)	1.4 percentage of participants	—
Initial Phase: Percentage of Participants With Pruritus Scores Week 2- LOCF: Score 1 (Mild)	53.5 percentage of participants	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Maintenance Phase: Clobex® Shampoo n=288 Participants In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05% (W/W) twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).	Maintenance Phase: Clobex® Vehicle Shampoo In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Baseline: Score 0 (None)	0 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Baseline: Score 1 (Mild)	1.7 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Baseline: Score 2 (Moderate)	47.2 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Baseline: Score 3 (Severe)	45.5 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Baseline: Score 4 (Very Severe)	5.6 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Week 2 - LOCF: Score 0 (None)	2.4 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Week 2 - LOCF: Score 1 (Mild)	39.6 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Week 2 - LOCF : 2: Moderate	44.1 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Week 2 - LOCF: Score 3 (Severe)	13.2 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Week 2 - LOCF: Score 4 (Very Severe)	0.4 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Week 4 - LOCF: Score 0 (None)	12.2 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Week 4 - LOCF: Score 1 (Mild)	51.4 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Week 4 - LOCF: Score 2 (Moderate)	30.9 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Week 4 - LOCF: Score 3 (Severe)	4.9 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Erythema at Week 4 - LOCF: Score 4 (Very Severe)	0.7 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Baseline: Score 1 (Mild)	0.7 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Baseline: Score 2 (Moderate)	42.0 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Baseline: Score 3 (Severe)	49.7 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Week 2-LOCF: Score 0 (None)	5.9 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Week 2-LOCF: Score 1 (Mild)	35.1 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Week 2-LOCF: Score 2 (Moderate)	45.5 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Week 2-LOCF: Score 4 (Very Severe)	2.8 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Week 4-LOCF: Score 0 (None)	14.2 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Week 4-LOCF: Score 1 (Mild)	50.7 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Week 4-LOCF: Score 2 (Moderate)	30.6 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Week 4-LOCF: Score 3 (Severe)	3.5 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Week 4-LOCF: Score 4 (Very Severe)	1.0 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Baseline: Score 0 (None)	0.7 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Baseline: score 1 (Mild)	4.9 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Baseline: Score 2 (Moderate)	54.2 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Baseline: Score 3 (Severe)	36.5 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Baseline: Score 4 (Very Severe)	3.8 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Week 2-LOCF: Score 0 (None)	10.8 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Week 2-LOCF: Score 1 (Mild)	37.5 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Week 2-LOCF: Score 2 (Moderate)	43.4 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Week 2-LOCF: Score 3 (Severe)	6.9 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Week 2- LOCF: Score 4 (Very Severe)	1.4 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Week 4- LOCF: Score 0 (None)	23.6 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Week 4- LOCF: Score 1 (Mild)	49.3 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Week 4-LOCF: Score 2 (Moderate)	23.3 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Week 4- LOCF: Score 3 (Severe)	2.8 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Baseline: Score 0 (None)	0 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Baseline: Score 4: (Very Severe)	7.6 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Scaling at Week 2-LOCF: Score 3 (Severe)	10.8 percentage of participants	—
Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores Plaque Thickening at Week 4- LOCF: Score 4 (Very Severe)	1.0 percentage of participants	—

SECONDARY outcome

Timeframe: 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. Relapse was categorized into relapse or no relapse. Percentage of participants with relapse were reported.

Outcome measures

Outcome measures
Measure	Maintenance Phase: Clobex® Shampoo n=106 Participants In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05% (W/W) twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).	Maintenance Phase: Clobex® Vehicle Shampoo n=111 Participants In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).
Maintenance Phase: Percentage of Participants Who Had First Relapse Maintenance Baseline : Relapse	0 percentage of participants	0 percentage of participants
Maintenance Phase: Percentage of Participants Who Had First Relapse Week 16 : Relapse	62.9 percentage of participants	89.2 percentage of participants
Maintenance Phase: Percentage of Participants Who Had First Relapse Week 20 : Relapse	66.7 percentage of participants	90.1 percentage of participants
Maintenance Phase: Percentage of Participants Who Had First Relapse Week 24 : Relapse	68.9 percentage of participants	91.9 percentage of participants
Maintenance Phase: Percentage of Participants Who Had First Relapse Week 4 : Relapse	41 percentage of participants	64.5 percentage of participants
Maintenance Phase: Percentage of Participants Who Had First Relapse Week 8 : Relapse	52.8 percentage of participants	76.6 percentage of participants
Maintenance Phase: Percentage of Participants Who Had First Relapse Week 12 : Relapse	55.7 percentage of participants	84.5 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Maintenance Phase: Clobex® Shampoo n=68 Participants In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05% (W/W) twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).	Maintenance Phase: Clobex® Vehicle Shampoo n=97 Participants In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).
Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse 0: None	13.2 percentage of participants	7.2 percentage of participants
Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse 1: Mild	29.4 percentage of participants	26.8 percentage of participants
Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse 2: Moderate	51.5 percentage of participants	52.6 percentage of participants
Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse 3: Severe	5.9 percentage of participants	13.4 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Maintenance Phase: Clobex® Shampoo n=68 Participants In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05% (W/W) twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).	Maintenance Phase: Clobex® Vehicle Shampoo n=97 Participants In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Erythema: Score 3 (Severe)	25.0 percentage of participants	30.9 percentage of participants
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Plaque Thickening: Score 1 (Mild)	17.6 percentage of participants	14.4 percentage of participants
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Plaque Thickening: Score 2 (Moderate)	64.7 percentage of participants	67.0 percentage of participants
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Plaque Thickening : Score 3 (Severe)	16.2 percentage of participants	14.4 percentage of participants
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Plaque Thickening: Score 0 (None)	1.5 percentage of participants	2.1 percentage of participants
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Erythema: Score 0 (None)	1.5 percentage of participants	0 percentage of participants
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Erythema: Score 1 (Mild)	13.2 percentage of participants	13.4 percentage of participants
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Erythema: Score 2 (Moderate)	57.4 percentage of participants	54.6 percentage of participants
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Erythema: Score 4 (Very Severe)	2.9 percentage of participants	1 percentage of participants
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Scaling: Score 1 (Mild)	4.4 percentage of participants	4.1 percentage of participants
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Scaling: Score 2 (Moderate)	57.4 percentage of participants	64.9 percentage of participants
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Scaling: Score 3 (Severe)	35.3 percentage of participants	29.9 percentage of participants
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Scaling: Score 4 (Very Severe)	2.9 percentage of participants	1.0 percentage of participants
Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse Plaque Thickening: Score 4 (Very Severe)	0 percentage of participants	2.1 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Maintenance Phase: Clobex® Shampoo n=106 Participants In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05% (W/W) twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).	Maintenance Phase: Clobex® Vehicle Shampoo n=111 Participants In maintenance double-blind phase, participants presented with a good efficacy (GSS \<=2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).
Maintenance Phase: Percentage of Participants With Number of Relapses Experienced 4: Two Consecutive Relapses	25.5 percentage of participants	26.1 percentage of participants
Maintenance Phase: Percentage of Participants With Number of Relapses Experienced 0: Zero Relapse	31.1 percentage of participants	8.1 percentage of participants
Maintenance Phase: Percentage of Participants With Number of Relapses Experienced 1: One Relapse	26.4 percentage of participants	22.5 percentage of participants
Maintenance Phase: Percentage of Participants With Number of Relapses Experienced 2: Two Relapse	9.4 percentage of participants	25.2 percentage of participants
Maintenance Phase: Percentage of Participants With Number of Relapses Experienced 3: Three Relapse	7.5 percentage of participants	18.0 percentage of participants

Adverse Events

Initial Phase:- Clobex® Shampoo

Serious events: 3 serious events

Other events: 39 other events

Deaths: 1 deaths

Maintenance Phase: Clobex® Shampoo

Serious events: 2 serious events

Other events: 44 other events

Deaths: 0 deaths

Maintenance Phase: Clobex® Vehicle Shampoo

Serious events: 5 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Initial Phase:- Clobex® Shampoo n=288 participants at risk In initial open-label phase, participants were applied Clobetasol Propionate 0.05% (W/W) shampoo topically to the scalp once daily (twice a week) for 4 weeks (weekly dose was not more than 50 grams \[50 Milliliter\]).	Maintenance Phase: Clobex® Shampoo n=106 participants at risk In maintenance double-blind phase, participants presented with a good efficacy (GSS \<= 2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05% (W/W) twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse \[i.e., GSS \> 2\] participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).	Maintenance Phase: Clobex® Vehicle Shampoo n=111 participants at risk In maintenance double-blind phase, participants presented with a good efficacy (GSS ≤ 2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams \[50 milliliter\]). In case of relapse (i.e., GSS \> 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS \<= 2, participants were re-entering the maintenance regimen (twice a week).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.35% 1/288 • Number of events 1 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.00% 0/106 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.00% 0/111 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.
Infections and infestations Pneumonia	0.35% 1/288 • Number of events 1 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.00% 0/106 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.00% 0/111 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.
Vascular disorders Aortic aneurysm rupture	0.35% 1/288 • Number of events 1 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.00% 0/106 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.00% 0/111 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.
Renal and urinary disorders Renal failure	0.00% 0/288 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.00% 0/106 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.90% 1/111 • Number of events 1 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/288 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.00% 0/106 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.90% 1/111 • Number of events 1 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.
Nervous system disorders Syncope	0.00% 0/288 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.00% 0/106 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.90% 1/111 • Number of events 2 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/288 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.94% 1/106 • Number of events 1 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.00% 0/111 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma stage unspecified	0.00% 0/288 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.94% 1/106 • Number of events 1 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.00% 0/111 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/288 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.00% 0/106 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.90% 1/111 • Number of events 1 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.
Gastrointestinal disorders Abdominal Hernia	0.00% 0/288 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.00% 0/106 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.	0.90% 1/111 • Number of events 1 • From baseline up to Week 28 Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.

Other adverse events

Additional Information

Clinical Operations

Galderma

Phone: 817 961 5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER