Subject preference comparison between Clobetasol propionate shampoo, 0.05% and three other topical corticosteroids in the treatment of moderate to severe Scalp psoriasis - Subject preference of topical corticosteroids in scalp psoriasis

Phase 1

• Conditions: MedDRA version: 8.1 Level: LLT Classification code 10037157 Term: Psoriasis of scalp; Moderate to Severe Scalp Psoriasis with a Global Severity Score of 3 at least on a scale from 0 to 5.

• Registration Number: EUCTR2006-003073-27-GB
• Lead Sponsor: Galderma R&D

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

Inclusion Criteria to enter Treatment Period I”
1. Male or female subjects, 18 years of age or older,
2. Subjects with moderate to severe scalp psoriasis (defined as global severity score of at least 3 on a 6-point scale),
3. Female subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly effective method of contraception during the study: oral contraception, IUD, systemic (injectable or patch) contraception, strict abstinence or partner had a vasectomy,
4. Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, are not required to have a UPT at the beginning of the study,
5. Subjects who signed written informed consent prior to any study procedures,
6. Subjects willing and capable of cooperating to the extent and degree required by the protocol,

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects who need systemic treatment for their body psoriasis,
2. Subjects who are at risk in terms of precautions, warnings and contra-indication 3. Female subjects who are pregnant, nursing or planning a pregnancy during the study,
4. Subjects who have participated in another investigational drug or device research study within 30 days of enrolment,
5. Subjects with a washout period for topical treatment(s) on the scalp less than:
• Corticosteroids2 weeks
• All other anti-psoriasis medications (including, but not restricted to: vitamin D derivatives, retinoids, salicylic acid, urea, coal tar and anthralin)2 weeks
• UV-light therapy2 weeks
6. Subjects with a washout period for systemic treatment(s) less than:
• PUVA therapy4 weeks
• Biological therapies (e.g. alefacept, efalizumab, etanercept, infliximab) 12 weeks
• Treatments other than biologicals with a possible efficacy on psoriasis (such as acitretin, isotretinoin, methotrexate, cyclosporine, corticosteroid, hydroxycarbamide, azathioprine )4 weeks
• Treatment known to worsen psoriasis (such as lithium, beta-blockers, antimalarials, ACE inhibitors)*2 weeks
* NOTE: unless subjects have been on treatment for at least 6 months and their psoriasis considered stable at study inclusion
7. Subjects with an history of adverse response (either severe side-effects or corticoresistance) to topical or systemic steroid therapy,
8. Subjects who plan to have intensive UV sun exposure during the study (mountain sports, UV radiation, sunbathing, etc…),
9. Subject with a condition or who is in a situation which, in the investigator’s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject’s participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: ;<br> Primary end point(s): Primary variable (on PP and ITT population) to be ananlysed on this study will be: Subjects’ Overall preference at the end of period II. So The Primary end point will be end of treatment period II.<br> ;Main Objective: The objective of this study is to compare subject’s overall preference (in terms of efficacy, side-effects, impact on daily routine and cosmetic properties) between Clobetasol propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis.