Clinical trial NCT00862654: Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis
Official title: Efficacy and Safety of Clobetasol Propionate Shampoo 0.05% Used in Association With an Antifungal Shampoo in the Treatment of Moderate to Severe Scalp Seborrheic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scalp Seborrheic Dermatitis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2009-03-17
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Severity Score (TSS): Percent Change From Baseline at Week 4
timeFrame: baseline and week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Galderma Investigational Center
city: Bruxelles
country: Belgium
facility: Galderma Investigational Center
city: Geel
country: Belgium
facility: Galderma Investigational Center
city: Gent
country: Belgium
facility: Galderma Investigational Center
city: Liege
country: Belgium
facility: Galderma Investigational Center
city: Mons
country: Belgium
facility: Galderma Investigational Center
city: Paris
country: France
facility: Galderma Investigational Center
city: Berlin
country: Germany
facility: Galderma Investigational Center
city: Bonn
country: Germany
facility: Galderma Investigational Center
city: Hamburg
country: Germany
facility: Galderma Investigational Center
city: Lubeck
country: Germany
facility: Galderma Investigational Center
city: Mahlow
country: Germany
facility: Galderma Investigational Center
city: Wuppertal
country: Germany
facility: Galderma Investigational Center
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Center
city: Guadalajara
country: Mexico
facility: Galderma Investigational Center
city: Mexico
country: Mexico
facility: Galderma Investigational Center
city: Naucalpan
country: Mexico
facility: Galderma Investigational Center
city: Zapopan, Jalisco
country: Mexico
facility: Galderma Investigational Center
Study officials:
affiliation: Nice Hospital (France)
name: Jean-Paul Ortonne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.