Trial Outcomes & Findings for Subject Preference for Scalp Psoriasis Treatment (NCT NCT00438399)

Last Updated: 2021-02-18

Results Overview

Subjects' Overall preference at the end of Period II. The purpose was to demonstrate a superiority of Clobetasol propionate shampoo 0.05% therapy compared to any of three other topical comparators, in terms of subject's overall preference: "C. propionate shampoo a lot better than the comparator",C. propionate shampoo a lillte bit better than the comparator", "Comparator a lot better than C. propionate shampoo", Comparator a lillte bit better than C. propionate shampoo". This was to be shown using a non parametric two-sided Wilcoxon rank Signed test, on Intention to Treat (ITT) population.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

219 participants

Primary outcome timeframe

End of period II (up to 16 weeks)

Results posted on

2021-02-18

Participant Flow

Patients were enrolled in 18 centres in Italy, Spain, United Kingdom and Germany between 19 February 2007 until 22 January 2008

219 participants recruited.

Participant milestones

Participant milestones
Measure	C. Propionate-Wash Out-Corticosteroid 1 Clobetasol propionate Shampoo first, then Corticosteroid 1	Corticosteroid 1-Wash Out-C. Propionate Corticosteroid 1 first then Clobetasol propionate Shampoo	C. Propionate-Wash Out-Corticosteroid 2 Clobetasol propionate Shampoo first, then Corticosteroid 2	Corticosteroid 2-Wash Out-C. Propionate Corticosteroid 2 first, then Clobetasol propionate shampoo	C. Propionate -Wash Out-Corticosteroid 3 Clobetasol propionate shampoo first then Corticosteroid 3	Corticosteroid 3-Wash Out-C. Propionate Corticosteroid 3 first, then Clobetasol propionate
Overall Study STARTED	38	40	35	36	33	37
Overall Study TREATED & ANALYZED	30	32	28	32	30	31
Overall Study COMPLETED	30	32	28	32	30	31
Overall Study NOT COMPLETED	8	8	7	4	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	C. Propionate-Wash Out-Corticosteroid 1 Clobetasol propionate Shampoo first, then Corticosteroid 1	Corticosteroid 1-Wash Out-C. Propionate Corticosteroid 1 first then Clobetasol propionate Shampoo	C. Propionate-Wash Out-Corticosteroid 2 Clobetasol propionate Shampoo first, then Corticosteroid 2	Corticosteroid 2-Wash Out-C. Propionate Corticosteroid 2 first, then Clobetasol propionate shampoo	C. Propionate -Wash Out-Corticosteroid 3 Clobetasol propionate shampoo first then Corticosteroid 3	Corticosteroid 3-Wash Out-C. Propionate Corticosteroid 3 first, then Clobetasol propionate
Overall Study Lost to Follow-up	2	2	1	1	1	1
Overall Study Adverse Event	0	0	1	1	0	1
Overall Study Withdrawal by Subject	5	6	3	2	2	2
Overall Study Protocol Violation	0	0	1	0	0	1
Overall Study Subje stopped study	0	0	1	0	0	0
Overall Study Pregnancy	0	0	0	0	0	1
Overall Study Patien stopped study at visit 4 by error	1	0	0	0	0	0

Baseline Characteristics

Subject Preference for Scalp Psoriasis Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C. Propionate Compared to Corticosteroid 1 n=78 Participants C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily	C. Propionate Compared to Corticosteroid 2 n=71 Participants C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily	C. Propionate Compared to Corticosteroid 3 n=70 Participants C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily	Total n=219 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=5 Participants	55 Participants n=7 Participants	57 Participants n=5 Participants	170 Participants n=4 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	48 Participants n=4 Participants
Age, Continuous	50.8 years STANDARD_DEVIATION 15.9 • n=5 Participants	49.2 years STANDARD_DEVIATION 14.9 • n=7 Participants	47.8 years STANDARD_DEVIATION 16.2 • n=5 Participants	49.3 years STANDARD_DEVIATION 15.6 • n=4 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	32 Participants n=7 Participants	36 Participants n=5 Participants	113 Participants n=4 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	39 Participants n=7 Participants	34 Participants n=5 Participants	106 Participants n=4 Participants
Region of Enrollment Italy	16 participants n=5 Participants	16 participants n=7 Participants	16 participants n=5 Participants	48 participants n=4 Participants
Region of Enrollment United Kingdom	17 participants n=5 Participants	15 participants n=7 Participants	11 participants n=5 Participants	43 participants n=4 Participants
Region of Enrollment Spain	9 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants	23 participants n=4 Participants
Region of Enrollment Germany	36 participants n=5 Participants	35 participants n=7 Participants	34 participants n=5 Participants	105 participants n=4 Participants

PRIMARY outcome

Timeframe: End of period II (up to 16 weeks)

Population: Intent to Treat population (ITT).

Outcome measures

Outcome measures
Measure	C. Propionate Compared to Corticosteroid 1 n=63 Participants C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily	C. Propionate Compared to Corticosteroid 2 n=60 Participants C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily	C. Propionate Compared to Corticosteroid 3 n=55 Participants C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily
Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator	28.5 Percentage of participants	31.6 Percentage of participants	21.8 Percentage of participants

Adverse Events

Corticosteroid 1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Corticosteroid 2

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Corticosteroid 3

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Clobetasol Propionate Shampoo

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Corticosteroid 1 n=72 participants at risk All subjects having used Corticosteroid 1	Corticosteroid 2 n=67 participants at risk All subjects having used Corticosteroid 2	Corticosteroid 3 n=65 participants at risk All subjects having used Corticosteroid 3	Clobetasol Propionate Shampoo n=199 participants at risk All subjects having used Clobetasol propionate shampoo
Gastrointestinal disorders UNCLEAR ABDOMINAL PAIN - MECHANICAL SUBILEUS	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	0.00% 0/65 • During the study period (maximum of 16 weeks)	0.50% 1/199 • Number of events 1 • During the study period (maximum of 16 weeks)
Gastrointestinal disorders HOSPITALISATION DUE TO NAUSEA	0.00% 0/72 • During the study period (maximum of 16 weeks)	1.5% 1/67 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/65 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
General disorders HOSPITALIZATION DUE TO MALAISE	0.00% 0/72 • During the study period (maximum of 16 weeks)	1.5% 1/67 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/65 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Cardiac disorders ANGINA PECTORIS	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	0.00% 0/65 • During the study period (maximum of 16 weeks)	0.50% 1/199 • Number of events 1 • During the study period (maximum of 16 weeks)
Infections and infestations RESPIRATORY INFECTION	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	0.00% 0/65 • During the study period (maximum of 16 weeks)	0.50% 1/199 • Number of events 1 • During the study period (maximum of 16 weeks)
Immune system disorders ALLERGIC REACTION	0.00% 0/72 • During the study period (maximum of 16 weeks)	1.5% 1/67 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/65 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Hepatobiliary disorders CHOLECYSTOLITHIASIS	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	1.5% 1/65 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)

Other adverse events

Additional Information

Farzaneh SIDOU Clinical Project Manager

Galderma

Phone: 00 33 4 93 95 70 70

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor to review and approval at least 2 months prior to the date of intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
Publication restrictions are in place

Restriction type: OTHER

Measure	Corticosteroid 1 n=72 participants at risk All subjects having used Corticosteroid 1	Corticosteroid 2 n=67 participants at risk All subjects having used Corticosteroid 2	Corticosteroid 3 n=65 participants at risk All subjects having used Corticosteroid 3	Clobetasol Propionate Shampoo n=199 participants at risk All subjects having used Clobetasol propionate shampoo
Infections and infestations NASOPHARYNGITIS	2.8% 2/72 • Number of events 2 • During the study period (maximum of 16 weeks)	1.5% 1/67 • Number of events 1 • During the study period (maximum of 16 weeks)	3.1% 2/65 • Number of events 2 • During the study period (maximum of 16 weeks)	2.5% 5/199 • Number of events 5 • During the study period (maximum of 16 weeks)
Infections and infestations HORDEOLUM	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	3.1% 2/65 • Number of events 2 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Nervous system disorders HEADACHE	1.4% 1/72 • Number of events 1 • During the study period (maximum of 16 weeks)	4.5% 3/67 • Number of events 4 • During the study period (maximum of 16 weeks)	4.6% 3/65 • Number of events 3 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Skin and subcutaneous tissue disorders FOLLICULITIS	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	3.1% 2/65 • Number of events 2 • During the study period (maximum of 16 weeks)	0.50% 1/199 • Number of events 1 • During the study period (maximum of 16 weeks)
Skin and subcutaneous tissue disorders SKIN BURNING SENSATION	2.8% 2/72 • Number of events 2 • During the study period (maximum of 16 weeks)	1.5% 1/67 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/65 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Infections and infestations RHINITIS	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	1.5% 1/65 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Infections and infestations IMPETIGO	0.00% 0/72 • During the study period (maximum of 16 weeks)	1.5% 1/67 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/65 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Infections and infestations RASH PUSTULAR	0.00% 0/72 • During the study period (maximum of 16 weeks)	1.5% 1/67 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/65 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Infections and infestations SINUSITIS	0.00% 0/72 • During the study period (maximum of 16 weeks)	1.5% 1/67 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/65 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Infections and infestations EAR INFECTION	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	1.5% 1/65 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	1.5% 1/65 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	1.5% 1/65 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Respiratory, thoracic and mediastinal disorders EXPISTAXIS	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	1.5% 1/65 • Number of events 3 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Skin and subcutaneous tissue disorders PSORIASIS	0.00% 0/72 • During the study period (maximum of 16 weeks)	1.5% 1/67 • Number of events 1 • During the study period (maximum of 16 weeks)	1.5% 1/65 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Skin and subcutaneous tissue disorders SKIN IRRITATION	0.00% 0/72 • During the study period (maximum of 16 weeks)	1.5% 1/67 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/65 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Skin and subcutaneous tissue disorders PHOTOSENSITIVITY REACTION	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	1.5% 1/65 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Skin and subcutaneous tissue disorders RASH	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	1.5% 1/65 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	1.5% 1/65 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Vascular disorders HYPOTENSION	0.00% 0/72 • During the study period (maximum of 16 weeks)	1.5% 1/67 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/65 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Investigations HEPATIC ENZYME INCREASED	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	1.5% 1/65 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BOWEN'S DISEASE	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	1.5% 1/65 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN PAPILLOMA	0.00% 0/72 • During the study period (maximum of 16 weeks)	0.00% 0/67 • During the study period (maximum of 16 weeks)	1.5% 1/65 • Number of events 1 • During the study period (maximum of 16 weeks)	0.00% 0/199 • During the study period (maximum of 16 weeks)