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OpenTrials
Completed

NCT Number: NCT00862654

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

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

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Key information

Conditions

Scalp Seborrheic Dermatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Galderma Investigational Center, Bruges, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

ketoconazole shampoo (2/week)

Drug

Monotherpay ketoconazole shampoo (2/week)

Primary outcomes

  1. Total Severity Score (TSS): Percent Change From Baseline at Week 4

    Time frame: baseline and 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Acronym: Escape

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 17, 2009
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.