Condition category
Skin and Connective Tissue Diseases
Date applied
12/08/2009
Date assigned
11/02/2010
Last edited
11/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Luigi Naldi

ORCID ID

Contact details

Centro GISED
U.O. Dermatologica
Ospedali Riuniti Di Bergamo
L.go Barozzi
1
Bergamo
24100
Italy
luigi.naldi@gised.it

Additional identifiers

EudraCT number

2005-003050-96

ClinicalTrials.gov number

Protocol/serial number

04EU/BMT06; EudraCT No.: 2005-003050-96

Study information

Scientific title

Multicentre, prospective, assessor-blind, in parallel groups randomised and versus reference marketed product controlled confirmatory trial of the efficacy and safety of Institut Biochimique SA (IBSA) 0.1% betamethasone valerate (BMV) medicated plaster for the treatment of chronic plaque psoriasis

Acronym

Study hypothesis

To ascertain if Institut Biochimique SA (IBSA) 0.1% betamethasone valerate (BMV) medicated plaster is significantly more effective as compared to the reference marketed BMV 0.1% cream for the treatment of chronic plaque psoriasis, when applied daily during a period of 3 to 5 weeks (superiority design).

Ethics approval

Local medical ethics committee (Comitato di Bioetica dell'Azienda Ospedali Riuniti di Bergamo) approved on the 30th November 2005 (ref: 1681)

Study design

Phase III prospective randomised assessor-blind controlled multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mild to moderate chronic plaque psoriasis

Intervention

Test drug:
IBSA BMV medicated plaster, is a 75 cm^2 plaster containing 2.25 mg of BMV as active ingredient (= 0.03 mg/cm^2); plaster administered topically on the target lesions once a day (morning), and worn for not less than 20 consecutive hours. A minimum of two and a maximum of eight plasters, based on number and extension of plaques identified as target areas.

Comparator product:
BetnevalĀ® 0.1% cream (GlaxoSmithKline), supplied as 30 g cream tubes. Differently from the plasters, cream will be applied twice a day on the target lesions, morning and evening. An adequate amount of cream, based on number and extension of the plaques identified as target areas, The products application will be repeated daily during 3 or 5 consecutive weeks, according to the treatment outcome.

Patients will be required to concomitantly treat non-target plaques only with a bland emollient (urea 5%) during the same period.

Intervention type

Drug

Phase

Phase III

Drug names

0.1% betamethasone valerate (BMV) medicated plaster, reference marketed product

Primary outcome measures

Number of patients showing remission (i.e. the disappearance of the active lesions of the skin areas identified as target areas) after 3 weeks of treatment, based on the Psoriasis Global Assessment (PGA) score as independently evaluated by two blind assessors based on digitalised images.

Secondary outcome measures

1. Number (%) of patients with remission after 3 weeks of treatment as assessed by the principal Investigator at each centre and by the patient
2. Number (%) of patients with remission after 5 weeks of treatment as assessed by the blind assessors, the principal Investigator at each centre and the patient
3. Changes from baseline of total extension of target lesions, as measured by an independent blind operator, after 3 and 5 weeks of treatment
4. Changes from baseline in PGA score assessed at each visit (week 3 and week 5) by the blind assessors, the principal Investigator at each centre and the patient
5. Patient's self-assessment of symptoms severity (itching, soreness) by means of a 10-point severity categorical scale (from 0 = no symptoms, to 10 = very severe symptoms), after 3 and 5 weeks of treatment
6. Patient's assessment of treatment acceptability/satisfaction, by means of a 10-point categorical scale (from 0 = very poor, to 10 = excellent), at the end of the treatment period (either week 3 or week 5)
7. Patient's assessment of ease of use by means of a 10-point categorical scale (from 0 = very poor, to 10 = excellent), at the end of the treatment period (either week 3 or week 5)
8. Number (%) of patients (among those having reached a complete remission at the end of treatment) showing patent relapse of the disease, and number (%) of patients showing disease rebound after treatment interruption
9. Time to relapse and/or rebound
10. Safety:
10.1. General adverse events (AEs)
10.2. Patient's assessment of treatment local tolerability, by means of a 10-point categorical scale (from 0 = very poor, to 10 = excellent), at the end of the treatment period (either week 3 or week 5)

Overall trial start date

11/04/2006

Overall trial end date

11/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subjects (outpatients) of both genders
2. Aged 18 years or more
3. Suffering from stable chronic plaque psoriasis (psoriasis vulgaris), involving less than 10% of the body surface area (BSA) (i.e. mild to moderate psoriasis according to CHMP/EWP/2454/02corr19) and presenting with psoriatic plaques in extensory skin areas, i.e. elbow and/or knee
4. Have at least two plaques on extensory parts of limbs that must be each greater than or equal to 10 cm^2 but less than 150 cm^2 (surface area equivalent of two BMV medicated plasters). These plaques, defined as target areas, will be treated with the tested formulation, BMV medicated plaster, or with the comparator product, BMV 0.1% cream (not occluded), according to a computer generated, fully randomised sequence. When present, other affected skin areas, different from those identified as target plaques, will be treated only with a bland emollient (5% urea) during the whole treatment period.
5. Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must use an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline; pregnant or breast-feeding women will not be included
6. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
7. Ability to cooperate with the Investigator and to comply with the requirements of the entire study
8. Signed written informed consent prior to inclusion in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Guttate, pustular or other non-plaque form of psoriasis
2. More severe stage of chronic plaque psoriasis, needing a systemic therapeutic approach in order to control the disease and not amenable to topical treatment
3. No concurrent dermatological conditions that could interfere with the assessment of the psoriatic lesion
4. No underlying disease or medication that severely compromise the patient's immune system
5. No history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers to potentially affect the outcome of the study
6. No use of topical anti-psoriatic drugs during the two weeks before inclusion in this study
7. No use of a topical retinoids during the 4 weeks before inclusion in this study
8. No systemic antipsoriatic therapy (e.g. corticosteroids - including intralesional corticosteroid, vitamin D in high doses, vitamin D analogs, methotrexate, cyclosporin, UVB programs or UVA/psoralen programs) within 4 weeks before inclusion
9. No participation in the evaluation of any investigational drug during 3 months before the study

Recruitment start date

11/04/2006

Recruitment end date

11/06/2008

Locations

Countries of recruitment

France, Italy, Poland, Switzerland

Trial participating centre

Centro GISED
Bergamo
24100
Italy

Sponsor information

Organisation

Institut Biochimique SA (IBSA) (Switzerland)

Sponsor details

Via del Piano
P.O.Box 266
Pambio-Noranco
6915
Switzerland

Sponsor type

Industry

Website

http://www.ibsa.ch/welcome-intl/

Funders

Funder type

Industry

Funder name

Institut Biochimique SA (IBSA) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes