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

Phase 3

Completed

• Conditions: Scalp Seborrheic Dermatitis
• Interventions: Drug: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week); Drug: clobetasol propionate shampoo (2/week); Drug: clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week); Drug: ketoconazole shampoo (2/week)

• Registration Number: NCT00862654
• Lead Sponsor: Galderma R&D

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-15
• Study First Submitted QC: 2009-03-15
• Study First Posted: 2009-03-17
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2011-06-15
• Results First Submitted QC: 2011-07-19
• Status Verified: 2011-08
• Results First Posted: 2011-08-12
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C propionate 4/week + Ketoconasole 2/week	clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week)	Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
C propionate 2/week	clobetasol propionate shampoo (2/week)	Clobetasol propionate shampoo 0.05% (2/week)
C propionate 2/week + Ketoconasole 2/week	clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week)	Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
Ketoconazole 2/week	ketoconazole shampoo (2/week)	Ketoconazole shampoo 2% (2/week)

Primary Outcome Measures

Name	Time	Method
Total Severity Score (TSS): Percent Change From Baseline at Week 4	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.

Trial Locations

Locations (1)

Galderma Investigational Center; 🇲🇽 Zapopan, Jalisco, Mexico