Subject Preference for Scalp Psoriasis Treatment

NCT ID: NCT00438399

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-02-29

Brief Summary

The scalp is one of the most common affected sites in psoriatic patients as 79% of them have scalp involvement.It has also a psychological aspect with 31% of patients with scalp psoriasis indicating distress.

Topical agents remain the mainstay of treatment for scalp psoriasis. However, they are not always ideal because they might be inconvenient and messy to use, stain or damage hair.

The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the tradename of Clobex®) was developed to provide the strongest available corticosteroid as a short-contact therapy in order to improve the chances of it being effective and reduce the potential for traditional side-effects.

The objective of this study is to compare subject's overall preference between Clobetasol propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis.

Detailed Description

This study will be a multi-centre, investigator blinded, randomized, cross-over, intra-individual comparison in three parallel groups.

In each parallel group, Clobetasol propionate shampoo, 0.05% will be compared to one of the three chosen competitors, following a cross-over design.

Conditions

Scalp Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

C. propionate-Wash out-Corticosteroid 1

Clobetasol propionate Shampoo:

• Dose or Concentration: Clobetasol propionate 0.05% shampoo
• Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
• Duration of Treatment: 4 weeks as a maximum

Wash-out up to 8 weeks

Corticosteroid 1:

• Dose or Concentration: Corticosteroid 1 Foam
• Mode and Frequency of Administration:Twice daily, a "golf-ball" sized amount to be massaged into the affected area of the scalp
• Duration of Treatment: 4 weeks as a maximum

Group Type: ACTIVE_COMPARATOR

C. propionate - Corticosteroid 1

Intervention Type: DRUG

Twice daily application

C. propionate-Wash out-Corticosteroid 2

Clobetasol propionate Shampoo:

• Dose or Concentration: Clobetasol propionate 0.05% shampoo
• Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
• Duration of Treatment: 4 weeks as a maximum

Corticosteroid 2:

• Dose or Concentration: Corticosteroid 2 Lotion
• Mode and Frequency of Administration: Twice daily, a thin film to be applied to the affected area of the scalp and massaged gently and thoroughly into the skin
• Duration of Treatment: 4 weeks as a maximum

Group Type: ACTIVE_COMPARATOR

C. propionate- Corticosteroid 2

Intervention Type: DRUG

Twice daily application

C. propionate-Wash out-Corticosteroid 3

Clobetasol propionate Shampoo:

• Dose or Concentration: Clobetasol propionate 0.05% shampoo
• Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
• Duration of Treatment: 4 weeks as a maximum

Corticosteroid 3:

• Dose or Concentration: Corticosteroid 3 Scalp application
• Mode and Frequency of Administration: Twice daily, a thin film to be applied into the affected area of the dry scalp and rubbed gently into the scalp
• Duration of Treatment: 4 weeks as a maximum

Group Type: ACTIVE_COMPARATOR

C. propionate -Corticosteroid 3

Intervention Type: DRUG

Twice daily application

Corticosteroid 1-Wash out-C. propionate

Clobetasol propionate Shampoo:

• Dose or Concentration: Clobetasol propionate 0.05% shampoo
• Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
• Duration of Treatment: 4 weeks as a maximum

Corticosteroid 1:

• Dose or Concentration: Corticosteroid 1 Foam
• Mode and Frequency of Administration:Twice daily, a "golf-ball" sized amount to be massaged into the affected area of the scalp
• Duration of Treatment: 4 weeks as a maximum

Group Type: ACTIVE_COMPARATOR

Corticosteroid 1- C. propionate

Intervention Type: DRUG

Twice daily application

Corticosteroid 2-Wash out-C. propionate

Clobetasol propionate Shampoo:

• Dose or Concentration: Clobetasol propionate 0.05% shampoo
• Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
• Duration of Treatment: 4 weeks as a maximum

Corticosteroid 2:

• Dose or Concentration: Corticosteroid 2 Lotion
• Mode and Frequency of Administration: Twice daily, a thin film to be applied to the affected area of the scalp and massaged gently and thoroughly into the skin
• Duration of Treatment: 4 weeks as a maximum

Group Type: ACTIVE_COMPARATOR

Corticosteroid 2 - C. propionate

Intervention Type: DRUG

Twice daily application

Corticosteroid 3-Wash out-C. propionate

Clobetasol propionate Shampoo:

• Dose or Concentration: Clobetasol propionate 0.05% shampoo
• Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
• Duration of Treatment: 4 weeks as a maximum

Corticosteroid 3:

• Dose or Concentration: Corticosteroid 3 Scalp application
• Mode and Frequency of Administration: Twice daily, a thin film to be applied into the affected area of the dry scalp and rubbed gently into the scalp
• Duration of Treatment: 4 weeks as a maximum

Group Type: ACTIVE_COMPARATOR

Corticosteroid 3 - C. propionate

Intervention Type: DRUG

Twice daily application

Interventions

C. propionate - Corticosteroid 1

Twice daily application

Intervention Type: DRUG

C. propionate- Corticosteroid 2

Twice daily application

Intervention Type: DRUG

C. propionate -Corticosteroid 3

Twice daily application

Intervention Type: DRUG

Corticosteroid 1- C. propionate

Twice daily application

Intervention Type: DRUG

Corticosteroid 2 - C. propionate

Twice daily application

Intervention Type: DRUG

Corticosteroid 3 - C. propionate

Twice daily application

Intervention Type: DRUG

Other Intervention Names

CP shampoo compared to Corticosteroid 1; CP Shampoo compared to Corticosteroid 2; CP Shampoo compared to Corticosteroid 3; Corticosteroid 1 compared to CP Shampoo; Corticosteroid 2 compared to CP Shampoo; Corticosteroid 3 compared to CP Shampoo

Eligibility Criteria

Inclusion Criteria

• Male or female subjects, 18 years of age or older,
• Subjects with moderate to severe scalp psoriasis,
• Subjects who signed written informed consent prior to any study procedures.

Exclusion Criteria

• Subjects who need systemic treatment for their body psoriasis,
• Subjects who are at risk in terms of precautions, warnings and contra-indication,
• Female subjects who are pregnant, nursing or planning a pregnancy during the study,
• Subjects with a specific washout period for topical treatment(s) on the scalp,
• Subjects with a specific washout period for systemic treatment(s).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alberto Giannetti, Professor

Role: PRINCIPAL_INVESTIGATOR

Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy

Locations

Clinica Dermatologica Azienda Ospedaliera Policlinico di Modena

Modena, , Italy

Countries

Italy

Related Links

http://www.clobex.com/

Study product information

Other Identifiers

2006-003073-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RD.03.SPR.29064

Identifier Type: -

Identifier Source: org_study_id