Subject Preference for Scalp Psoriasis Treatment
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...
Brief Summary
Official Title: “Subject Preference Comparison Between Clobetasol Propionate Shampoo, 0.05% and Three Other Topical Corticosteroids in the Treatment of Moderate to Severe Scalp Psoriasis”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: January 2008
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: C. propionate - Corticosteroid 1
- Twice daily application
- Drug: C. propionate- Corticosteroid 2
- Twice daily application
- Drug: C. propionate -Corticosteroid 3
- Twice daily application
- Drug: Corticosteroid 1- C. propionate
- Twice daily application
- Drug: Corticosteroid 2 - C. propionate
- Twice daily application
- Drug: Corticosteroid 3 - C. propionate
- Twice daily application
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 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
- Active Comparator: 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
- Active Comparator: 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
- Active Comparator: 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
- Active Comparator: 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
- Active Comparator: 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
Outcome Measures for this Clinical Trial
Primary Measures
- Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator
- Time Frame: End of period II (up to 16 weeks)
Safety Issue?: No
- Time Frame: End of period II (up to 16 weeks)
Criteria for Participation in this Clinical Trial
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).
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Galderma Industry
Overall Clinical Trial Officials and Contacts
Alberto Giannetti, Professor Principal Investigator Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00438399
Study ID Number: RD.03.SPR.29064
ClinicalTrials.gov Identifier: NCT00438399
Health Authority: Italy: Ministry of Health
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00438399
