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

Galderma

Status and phase: Completed; Phase 3

Conditions: Scalp Seborrheic Dermatitis

Treatments: Drug: clobetasol propionate shampoo (2/week); Drug: clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week); Drug: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week); Drug: ketoconazole shampoo (2/week)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00862654

RD.03.SPR.29079

Details and patient eligibility

About

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

Full 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.

Enrollment: 326 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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326 participants in 4 patient groups

C propionate 4/week + Ketoconasole 2/week

Experimental group

Description:

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

Treatment:

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

C propionate 2/week + Ketoconasole 2/week

Experimental group

Description:

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

Treatment:

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

C propionate 2/week

Experimental group

Description:

Clobetasol propionate shampoo 0.05% (2/week)

Treatment:

Drug: clobetasol propionate shampoo (2/week)

Ketoconazole 2/week

Active Comparator group

Description:

Ketoconazole shampoo 2% (2/week)

Treatment:

Drug: ketoconazole shampoo (2/week)