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

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

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

Study Overview

• Status: Completed
• Conditions: Scalp Seborrheic Dermatitis
• Intervention / Treatment: 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)

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 Type: Interventional
• Enrollment (Actual): 326
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium
    • Galderma Investigational Center
  • Bruxelles, Belgium
    • Galderma Investigational Center
  • Geel, Belgium
    • Galderma Investigational Center
  • Gent, Belgium
    • Galderma Investigational Center
  • Liege, Belgium
    • Galderma Investigational Center
  • Mons, Belgium
    • Galderma Investigational Center
• France
  • Paris, France
    • Galderma Investigational Center
• Germany
  • Berlin, Germany
    • Galderma Investigational Center
  • Bonn, Germany
    • Galderma Investigational Center
  • Hamburg, Germany
    • Galderma Investigational Center
  • Lubeck, Germany
    • Galderma Investigational Center
  • Mahlow, Germany
    • Galderma Investigational Center
  • Wuppertal, Germany
    • Galderma Investigational Center
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Galderma Investigational Center
• Mexico
  • Guadalajara, Mexico
    • Galderma Investigational Center
  • Mexico, Mexico
    • Galderma Investigational Center
  • Naucalpan, Mexico
    • Galderma Investigational Center
  • Zapopan, Jalisco, Mexico
    • Galderma Investigational Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Jean-Paul Ortonne, MD, Nice Hospital (France)

Publications and helpful links

General Publications

• Ortonne JP, Nikkels AF, Reich K, Ponce Olivera RM, Lee JH, Kerrouche N, Sidou F, Faergemann J. Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0.05% combined with ketoconazole shampoo 2%: a randomized, controlled study. Br J Dermatol. 2011 Jul;165(1):171-6. doi: 10.1111/j.1365-2133.2011.10269.x.

Helpful Links

• Sponsor general information

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: March 15, 2009
• First Submitted That Met QC Criteria: March 15, 2009
• First Posted (Estimate): March 17, 2009

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Diseases, Eczematous; Sebaceous Gland Diseases; Dermatitis; Dermatitis, Seborrheic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Ketoconazole; Clobetasol
• Other Study ID Numbers: RD.03.SPR.29079