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

Study Overview
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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.

Official Title
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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

Conditions
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Scalp Seborrheic Dermatitis

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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C propionate 4/week + Ketoconasole 2/week<br>Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) | Drug: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week)<br>* Association: clobetasol propionate shampoo & ketoconazole shampoo<br>|
| Experimental: C propionate 2/week + Ketoconasole 2/week<br>Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) | Drug: clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week)<br>* Association: clobetasol propionate shampoo & ketoconazole shampoo<br>|
| Experimental: C propionate 2/week<br>Clobetasol propionate shampoo 0.05% (2/week) | Drug: clobetasol propionate shampoo (2/week)<br>* Monotherapy with clobetasol propionate shampoo<br>|
| Active Comparator: Ketoconazole 2/week<br>Ketoconazole shampoo 2% (2/week) | Drug: ketoconazole shampoo (2/week)<br>* Monotherpay ketoconazole shampoo (2/week)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |