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

Primary Purpose

Scalp Seborrheic Dermatitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

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

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

clobetasol propionate shampoo (2/week)

ketoconazole shampoo (2/week)

About this trial

This is an interventional treatment trial for Scalp Seborrheic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

C propionate 4/week + Ketoconasole 2/week

C propionate 2/week + Ketoconasole 2/week

C propionate 2/week

Ketoconazole 2/week

Arm Description

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

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

Clobetasol propionate shampoo 0.05% (2/week)

Ketoconazole shampoo 2% (2/week)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00862654

First Posted

March 15, 2009

Last Updated

February 16, 2021

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT00862654

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scalp Seborrheic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

326 (Actual)

8. Arms, Groups, and Interventions

Arm Title

C propionate 4/week + Ketoconasole 2/week

Arm Type

Experimental

Arm Description

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

Arm Title

C propionate 2/week + Ketoconasole 2/week

Arm Type

Experimental

Arm Description

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

Arm Title

C propionate 2/week

Arm Type

Experimental

Arm Description

Clobetasol propionate shampoo 0.05% (2/week)

Arm Title

Ketoconazole 2/week

Arm Type

Active Comparator

Arm Description

Ketoconazole shampoo 2% (2/week)

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

Association: clobetasol propionate shampoo & ketoconazole shampoo

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

Association: clobetasol propionate shampoo & ketoconazole shampoo

Intervention Type

Drug

Intervention Name(s)

clobetasol propionate shampoo (2/week)

Intervention Description

Monotherapy with clobetasol propionate shampoo

Intervention Type

Drug

Intervention Name(s)

ketoconazole shampoo (2/week)

Intervention Description

Monotherpay ketoconazole shampoo (2/week)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

baseline and week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Paul Ortonne, MD

Organizational Affiliation

Nice Hospital (France)

Official's Role

Principal Investigator

Facility Information:

Facility Name