CLINICAL EFFICACY EVALUATION OF A FIXED COMBINATION OF CALCITRIOL 3 µg/g WITH THREE CONCENTRATIONS (100, 250, 500µg/g) OF CLOBETASOL PROPIONATE AS SPRAY FORMULATION USING THE MODIFIED DUMAS-SCHOLTZ PSORIASIS MINI PLAQUE TEST UNDER NON-OCCLUSIVE CONDITIONS

Phase 1

• Conditions: Treatment of psoriasis vulgaris; MedDRA version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

• Registration Number: EUCTR2006-006487-32-FR
• Lead Sponsor: GALDERMA R&D SNC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-23
• Study Completion: 2007-05-14
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. The subject is male or female and at least 18 years old

2. The subject presents 8 target sites on one or more psoriasis plaques

3. If the subject is a female:

3.1 Of childbearing potential: one of the following contraception methods needs to be used by her for at least 5 consecutive weeks prior to study entry date and during the study:
- Oral contraception,
- Intra Uterine Device,
- Contraceptive patches, Injectable or implantable contraception
- Sexual abstinence
- Condom or partner with a vasectomy.

3.2 Of non-childbearing potential: she needs to be postmenopausal (absence of menstrual bleeding for 2 years) or had a hysterectomy, bilateral tubal ligation or bilateral ovariectomy

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. The subject has an underlying disease, which in the investigator’s opinion, would put the Subject at risk (e.g., uncontrolled chronic or serious diseases which would normally prevent participation in any clinical trial, such as a cancer, AIDS, severe cardiopathy),

2. The subject has an underlying disease, which in the investigator’s opinion, may confound the study assessments (e.g., other dermatological diseases, such as a dermatitis, eczema, etc.)

3. The female subject with a positive pregnancy test at baseline visit, breast-feeding or planning a pregnancy during the course of the study

4. The subject has acute guttate, pustular or erythrodermic psoriasis.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the clinical efficacy of a fixed combination of calcitriol 3µg/g with three concentrations (100µg/g, 250µg/g, 500µg/g) of clobetasol, by evaluation of their clinical efficacy in comparison to:<br><br>• The same concentration of clobetasol alone in the fixed combination vehicle (clobetasol monad)<br><br>• Two marketed products: <br>- Dermoval® cream (clobetasol propionate 500 µg/g) as representative of the class I corticosteroids;<br>- Daivobet® ointment (Calcipotriol 50µg/g / betamethasone dipropionate 500µg/g), the first fixed combination registered in the treatment of psoriasis, which contains a class II corticosteroid (betamethasone dipropionate).<br>;Secondary Objective: ;Primary end point(s):