Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis - Study Results

Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis (Escape)

This study has been completed.

Study NCT00862654 Information provided by Galderma

First Received on March 15, 2009. Last Updated on August 31, 2011 History of Changes

Results First Received: June 15, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Scalp Seborrheic Dermatitis
Interventions:	Drug: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week) Drug: clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week) Drug: clobetasol propionate shampoo (2/week) Drug: ketoconazole shampoo (2/week)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
C Propionate 4/Week + Ketoconazole 2/Week	Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
C Propionate 2/Week + Ketoconazole 2/Week	Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
C Propionate 2/Week	Clobetasol propionate shampoo 0.05% (2/week)
Ketakonazol 2/Week	Ketoconazole shampoo 2% (2/week)

Participant Flow: Overall Study

	C Propionate 4/Week + Ketoconazole 2/Week	C Propionate 2/Week + Ketoconazole 2/Week	C Propionate 2/Week	Ketakonazol 2/Week
STARTED	82	82	82	80
COMPLETED	76	74	76	74
NOT COMPLETED	6	8	6	6
Lack of Efficacy	1	0	1	0
Lost to Follow-up	1	2	1	3
Adverse Event	0	1	1	0
Pregnancy	1	1	0	0
Withdrawal by Subject	2	2	2	3
Subject mistake	0	1	0	0
Familly constraint	0	1	0	0
Never used study drugs	1	0	0	0
Included after end of inclusions	0	0	1	0

Baseline Characteristics

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Reporting Groups

	Description
C Propionate 4/Week + Ketoconazole 2/Week	Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
C Propionate 2/Week + Ketoconazole 2/Week	Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
C Propionate 2/Week	Clobetasol propionate shampoo 0.05% (2/week)
Ketakonazol 2/Week	Ketoconazole shampoo 2% (2/week)

Baseline Measures

	C Propionate 4/Week + Ketoconazole 2/Week	C Propionate 2/Week + Ketoconazole 2/Week	C Propionate 2/Week	Ketakonazol 2/Week	Total
Number of Participants [units: participants]	82	82	82	80	326
Age [units: participants]
<=18 years	2	1	3	1	7
Between 18 and 65 years	65	69	71	66	271
>=65 years	15	12	8	13	48
Age [units: years] Mean ± Standard Deviation	46.9 ± 16.0	43.8 ± 17.2	44.9 ± 15.3	44.7 ± 15.5	45.1 ± 16.0
Gender [units: participants]
Female	36	39	38	36	149
Male	46	43	44	44	177
Region of Enrollment [units: participants]
France	12	11	12	12	47
Mexico	17	18	18	17	70
Belgium	9	7	9	8	33
Germany	35	37	34	34	140
Korea, Republic of	9	9	9	9	36

Outcome Measures

1. Primary:

Total Severity Score (TSS): Percent Change From Baseline at Week 4 [ Time Frame: baseline and week 4 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Farzi Sidou, Clinical Project Manager
Organization: Galderma
phone: +33 4 93 95 70 51
e-mail: farzaneh.sidou@galderma.com

No publications provided by Galderma

Publications automatically indexed to this study:

Ortonne JP, Nikkels AF, Reich K, Ponce Olivera RM, Lee JH, Kerrouche N, Sidou F, Faergemann J. Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0·05% combined with ketoconazole shampoo 2%: a randomized, controlled study. Br J Dermatol. 2011 Jul;165(1):171-6.

Responsible Party:	Galderma
ClinicalTrials.gov Identifier:	NCT00862654 History of Changes
Other Study ID Numbers:	RD.03.SPR.29079
Study First Received:	March 15, 2009
Results First Received:	June 15, 2011
Last Updated:	August 31, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Mexico: Ministry of Health; South Korea: Korea Food and Drug Administration (KFDA)