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

Galderma R&D326 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

326

Conditions

Scalp Seborrheic Dermatitis

Interventions

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

Association: clobetasol propionate shampoo \& ketoconazole shampoo

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

Association: clobetasol propionate shampoo \& ketoconazole shampoo

clobetasol propionate shampoo (2/week)DRUG

Monotherapy with clobetasol propionate shampoo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

Galderma Investigational Center

Bruges, Belgium

Galderma Investigational Center

Brussels, Belgium

Outcomes

Primary Outcomes

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.

Time frame: baseline and week 4

Data from ClinicalTrials.gov

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