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

NCT ID: NCT00862654

Last Updated: 2021-02-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-02-28

Brief Summary

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The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.

Detailed Description

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The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in association with an antifungal shampoo (Ketoconazole 2%) in the treatment of moderate to severe scalp Seborrheic Dermatitis compared to the antifungal shampoo alone.

Conditions

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Scalp Seborrheic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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C propionate 4/week + Ketoconasole 2/week

Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)

Group Type EXPERIMENTAL

clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week)

Intervention Type DRUG

Association: clobetasol propionate shampoo \& ketoconazole shampoo

C propionate 2/week + Ketoconasole 2/week

Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)

Group Type EXPERIMENTAL

clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week)

Intervention Type DRUG

Association: clobetasol propionate shampoo \& ketoconazole shampoo

C propionate 2/week

Clobetasol propionate shampoo 0.05% (2/week)

Group Type EXPERIMENTAL

clobetasol propionate shampoo (2/week)

Intervention Type DRUG

Monotherapy with clobetasol propionate shampoo

Ketoconazole 2/week

Ketoconazole shampoo 2% (2/week)

Group Type ACTIVE_COMPARATOR

ketoconazole shampoo (2/week)

Intervention Type DRUG

Monotherpay ketoconazole shampoo (2/week)

Interventions

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clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week)

Association: clobetasol propionate shampoo \& ketoconazole shampoo

Intervention Type DRUG

clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week)

Association: clobetasol propionate shampoo \& ketoconazole shampoo

Intervention Type DRUG

clobetasol propionate shampoo (2/week)

Monotherapy with clobetasol propionate shampoo

Intervention Type DRUG

ketoconazole shampoo (2/week)

Monotherpay ketoconazole shampoo (2/week)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with moderate to severe scalp Seborrheic Dermatitis

Exclusion Criteria

* Subjects suffering from psoriasis,
* Subjects with a known allergy to one of the components of the test products,
* Female subjects who are pregnant, nursing or planning a pregnancy during the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Paul Ortonne, MD

Role: PRINCIPAL_INVESTIGATOR

Nice Hospital (France)

Locations

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Galderma Investigational Center

Bruges, , Belgium

Site Status

Galderma Investigational Center

Brussels, , Belgium

Site Status

Galderma Investigational Center

Geel, , Belgium

Site Status

Galderma Investigational Center

Ghent, , Belgium

Site Status

Galderma Investigational Center

Liège, , Belgium

Site Status

Galderma Investigational Center

Mons, , Belgium

Site Status

Galderma Investigational Center

Paris, , France

Site Status

Galderma Investigational Center

Berlin, , Germany

Site Status

Galderma Investigational Center

Bonn, , Germany

Site Status

Galderma Investigational Center

Hamburg, , Germany

Site Status

Galderma Investigational Center

Lübeck, , Germany

Site Status

Galderma Investigational Center

Mahlow, , Germany

Site Status

Galderma Investigational Center

Wuppertal, , Germany

Site Status

Galderma Investigational Center

Guadalajara, , Mexico

Site Status

Galderma Investigational Center

México, , Mexico

Site Status

Galderma Investigational Center

Naucalpan, , Mexico

Site Status

Galderma Investigational Center

Zapopan, Jalisco, , Mexico

Site Status

Galderma Investigational Center

Seoul, , South Korea

Site Status

Countries

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Belgium France Germany Mexico South Korea

References

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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. doi: 10.1111/j.1365-2133.2011.10269.x.

Reference Type DERIVED
PMID: 21707573 (View on PubMed)

Related Links

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http://www.galderma.com

Sponsor general information

Other Identifiers

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RD.03.SPR.29079

Identifier Type: -

Identifier Source: org_study_id

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