Subject Preference for Scalp Psoriasis Treatment

Galderma

Status and phase: Completed; Phase 3

Conditions: Scalp Psoriasis

Treatments: Drug: Corticosteroid 1- C. propionate; Drug: C. propionate -Corticosteroid 3; Drug: C. propionate - Corticosteroid 1; Drug: Corticosteroid 3 - C. propionate; Drug: C. propionate- Corticosteroid 2; Drug: Corticosteroid 2 - C. propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00438399

RD.03.SPR.29064

2006-003073-27 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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219 participants in 6 patient groups

C. propionate-Wash out-Corticosteroid 1

Active Comparator group

Description:

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

Treatment:

Drug: C. propionate - Corticosteroid 1

C. propionate-Wash out-Corticosteroid 2

Active Comparator group

Description:

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

Treatment:

Drug: C. propionate- Corticosteroid 2

C. propionate-Wash out-Corticosteroid 3

Active Comparator group

Description:

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

Treatment:

Drug: C. propionate -Corticosteroid 3

Corticosteroid 1-Wash out-C. propionate

Active Comparator group

Description:

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

Treatment:

Drug: Corticosteroid 1- C. propionate

Corticosteroid 2-Wash out-C. propionate

Active Comparator group

Description:

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

Treatment:

Drug: Corticosteroid 2 - C. propionate

Corticosteroid 3-Wash out-C. propionate

Active Comparator group

Description:

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

Treatment:

Drug: Corticosteroid 3 - C. propionate