Subject Preference for Scalp Psoriasis Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT00438399
First received: February 21, 2007
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Scalp Psoriasis
Drug: C. propionate - Corticosteroid 1
Drug: C. propionate- Corticosteroid 2
Drug: C. propionate -Corticosteroid 3
Drug: Corticosteroid 1- C. propionate
Drug: Corticosteroid 2 - C. propionate
Drug: Corticosteroid 3 - C. propionate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator [ Time Frame: End of period II (up to 16 weeks) ] [ Designated as safety issue: No ]
    Subjects' Overall preference at the end of Period II. The purpose was to demonstrate a superiority of Clobetasol propionate shampoo 0.05% therapy compared to any of three other topical comparators, in terms of subject's overall preference: "C. propionate shampoo a lot better than the comparator",C. propionate shampoo a lillte bit better than the comparator", "Comparator a lot better than C. propionate shampoo", Comparator a lillte bit better than C. propionate shampoo". This was to be shown using a non parametric two-sided Wilcoxon rank Signed test, on Intention to Treat (ITT) population.


Enrollment: 219
Study Start Date: February 2007
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: C. propionate - Corticosteroid 1
Twice daily application
Other Name: CP shampoo compared to Corticosteroid 1
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
Drug: C. propionate- Corticosteroid 2
Twice daily application
Other Name: CP Shampoo compared to Corticosteroid 2
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
Drug: C. propionate -Corticosteroid 3
Twice daily application
Other Name: CP Shampoo compared to Corticosteroid 3
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
Drug: Corticosteroid 1- C. propionate
Twice daily application
Other Name: Corticosteroid 1 compared to CP Shampoo
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
Drug: Corticosteroid 2 - C. propionate
Twice daily application
Other Name: Corticosteroid 2 compared to CP Shampoo
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
Drug: Corticosteroid 3 - C. propionate
Twice daily application
Other Name: Corticosteroid 3 compared to CP Shampoo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438399

Locations
Italy
Clinica Dermatologica Azienda Ospedaliera Policlinico di Modena
Modena, Italy, 41100
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Alberto Giannetti, Professor Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy
  More Information

Additional Information:
No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00438399     History of Changes
Other Study ID Numbers: RD.03.SPR.29064, 2006-003073-27
Study First Received: February 21, 2007
Results First Received: June 22, 2011
Last Updated: November 21, 2011
Health Authority: Italy: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines

Keywords provided by Galderma:
1 Galderma,
2 Scalp Psoriasis
3 Subject preference
4 Clobetasol propionate
5 Shampoo

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Clobetasol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014