Subject Preference for Scalp Psoriasis Treatment

NCT00438399 | Completed Phase 3 Results

• 2 other identifiers: RD.03.SPR.290642006-003073-27
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

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.

Conditions

Scalp Psoriasis

Keywords

1 Galderma,; 2 Scalp Psoriasis; 3 Subject preference; 4 Clobetasol propionate; 5 Shampoo

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator

  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.

  End of period II (up to 16 weeks)

Study Arms (6)

C. propionate-Wash out-Corticosteroid 1

ACTIVE COMPARATOR

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

C. propionate-Wash out-Corticosteroid 2

ACTIVE COMPARATOR

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

C. propionate-Wash out-Corticosteroid 3

ACTIVE COMPARATOR

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

Corticosteroid 1-Wash out-C. propionate

ACTIVE COMPARATOR

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

Corticosteroid 2-Wash out-C. propionate

ACTIVE COMPARATOR

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

Corticosteroid 3-Wash out-C. propionate

ACTIVE COMPARATOR

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

Interventions

C. propionate - Corticosteroid 1 DRUG

Twice daily application

Also known as: CP shampoo compared to Corticosteroid 1

C. propionate-Wash out-Corticosteroid 1

C. propionate- Corticosteroid 2 DRUG

Twice daily application

Also known as: CP Shampoo compared to Corticosteroid 2

C. propionate-Wash out-Corticosteroid 2

C. propionate -Corticosteroid 3 DRUG

Twice daily application

Also known as: CP Shampoo compared to Corticosteroid 3

C. propionate-Wash out-Corticosteroid 3

Corticosteroid 1- C. propionate DRUG

Twice daily application

Also known as: Corticosteroid 1 compared to CP Shampoo

Corticosteroid 1-Wash out-C. propionate

Corticosteroid 2 - C. propionate DRUG

Twice daily application

Also known as: Corticosteroid 2 compared to CP Shampoo

Corticosteroid 2-Wash out-C. propionate

Corticosteroid 3 - C. propionate DRUG

Twice daily application

Also known as: Corticosteroid 3 compared to CP Shampoo

Corticosteroid 3-Wash out-C. propionate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Clinica Dermatologica Azienda Ospedaliera Policlinico di Modena

Modena, 41100, Italy

Location

Related Links

• Study product information

Results Point of Contact

• Title: Farzaneh SIDOU Clinical Project Manager
• Organization: Galderma

farzaneh.sidou@galderma.com

00 33 4 93 95 70 70

Study Officials

• Alberto Giannetti, Professor

  Clinica Dermatologica Azienda Ospedaliera Policinico di Modena - Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2007
• First Posted: February 22, 2007
• Study Start: February 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2008
• Last Updated: February 18, 2021
• Results First Posted: December 23, 2011

Record last verified: 2011-11

Locations

IT (1)