Clinical trial NCT00438399
Conditions: Scalp Psoriasis
Keywords: 1 Galderma, 2 Scalp Psoriasis 3 Subject preference 4 Clobetasol propionate 5 Shampoo
Sponsor: Galderma R&D
Start date: 2007-02-01; Completion date: 2008-02-01
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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.

Arms: arm 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 arm 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 arm 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 arm 4: 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 arm 5: 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 arm 6: 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
Interventions: intervention 1: C. propionate - Corticosteroid 1 intervention 2: C. propionate- Corticosteroid 2 intervention 3: C. propionate -Corticosteroid 3 intervention 4: Corticosteroid 1- C. propionate intervention 5: Corticosteroid 2 - C. propionate intervention 6: Corticosteroid 3 - C. propionate
Intervention descriptions: intervention 1: Twice daily application intervention 2: Twice daily application intervention 3: Twice daily application intervention 4: Twice daily application intervention 5: Twice daily application intervention 6: Twice daily application

Protocol documents: