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

Scalp Seborrheic Dermatitis Clinical Trial

— Escape  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862654
• Other study ID #: RD.03.SPR.29079
• Status: Completed
• Phase: Phase 3
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: August 2011
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Scalp Seborrheic Dermatitis

Intervention

Drug:
• clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week)
Association: clobetasol propionate shampoo & ketoconazole shampoo
• clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week)
Association: clobetasol propionate shampoo & ketoconazole shampoo
• clobetasol propionate shampoo (2/week)
Monotherapy with clobetasol propionate shampoo
• ketoconazole shampoo (2/week)
Monotherpay ketoconazole shampoo (2/week)

Locations

Country	Name	City	State
Belgium	Galderma Investigational Center	Brugge
Belgium	Galderma Investigational Center	Bruxelles
Belgium	Galderma Investigational Center	Geel
Belgium	Galderma Investigational Center	Gent
Belgium	Galderma Investigational Center	Liege
Belgium	Galderma Investigational Center	Mons
France	Galderma Investigational Center	Paris
Germany	Galderma Investigational Center	Berlin
Germany	Galderma Investigational Center	Bonn
Germany	Galderma Investigational Center	Hamburg
Germany	Galderma Investigational Center	Lubeck
Germany	Galderma Investigational Center	Mahlow
Germany	Galderma Investigational Center	Wuppertal
Korea, Republic of	Galderma Investigational Center	Seoul
Mexico	Galderma Investigational Center	Guadalajara
Mexico	Galderma Investigational Center	Mexico
Mexico	Galderma Investigational Center	Naucalpan
Mexico	Galderma Investigational Center	Zapopan, Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Korea, Republic of,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Severity Score (TSS): Percent Change From Baseline at Week 4	Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9.	baseline and week 4

External Links

•   Sponsor general information