An Exploratory Psoriasis Plaque Test Study With Different Dose Combinations of Calcipotriol Plus Betamethasone Dipropionate in the Daivobet® Gel Vehicle in Psoriasis Vulgaris

NCT01837576 | Completed Phase 1

• 1 other identifier: LP0076-1016
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the antipsoriatic effect of 5 different combinations of calcipotriol plus betamethasone dipropionate in Daivobet® gel vehicle in compared to Daivobet® gel in order to explore/find other safe and effective combination of the two components.

Conditions

Psoriasis Vulgaris

Keywords

Psoriasis Vulgaris; Calcipotriol; Betamethasone Dipropionate

Outcome Measures

Primary Outcomes (1)

• The absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration)

  3 weeks

Secondary Outcomes (3)

• Absolute change in single clinical symptom score: erythema, scaling, infiltration at end of treatment and individual visits compared to baseline.

  3 weeks

• Absolute change in Total Clinical Score (TCS) at individual visits compared to baseline

  3 weeks

• The absolute change in total skin thickness and echopoor band thickness at end of treatment compared to baseline.

  3 weeks

Study Arms (1)

Calcipotriol plus BDP gel in different doses

EXPERIMENTAL

A-E: calcipotriol, BDP gel in different concentrations

Drug: Calcipotriol plus BDP gel in different doses

Interventions

Calcipotriol plus BDP gel in different doses DRUG

Topical , Once daily, 3 weeks

Also known as: Daivobet gel

Calcipotriol plus BDP gel in different doses

Eligibility Criteria

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

You may qualify if:

• Subject must provide written information.
• Age 18 years or above.
• Males, or females subjects.
• Subjects with lesions of psoriasis vulgaris located on arms and/or legs and/or trunk.
• Subjects with, in the opinion of the investigator, stable psoriasis
• Subjects with psoriasis lesions(plaques)assessed by a Total Clinical Score 4 to 9 inclusive but each individual item ≥ 1.
• Subjects willing and able to follow all the study procedures and complete the whole study.
• Subjects affiliated to a social security system.
• Female of childbearing potential with a negative urine pregnancy test

You may not qualify if:

• Female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding.
• Systemic treatment with biological therapies within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 halflives (whichever is longer) for experimental biological products prior to randomisation and during the study.
• Systemic treatments with all other therapies than biologicals, (e.g., corticosteroids, retinoids, immunosuppressants) within the 4 week period prior to randomisation and during the study.
• Subjects using one of the following topical drugs for the treatment of psoriasis prior to randomisation and during the study: Potent or very potent (WHO group III-IV) corticosteroids (4 weeks).
• Subjects using of phototherapy prior to randomisation and during the study:
• PUVA (4 weeks)
• UVB (2 weeks).
• Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:
• WHO group I-II corticosteroids (except if used fortreatment of scalp and/or facial psoriasis),
• Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. macrolides), Anthracen derivatives, Tar, Salicylic acid
• Subjects using emollients on the selected plaques within one week before randomisation and during the study.
• Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g.,beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomization and during the study.
• Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
• Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview.
• History of any severe disease or serious current condition which, in the opinion of the Investigator, would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results or the study course

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Centre de harmacologie Clinique Appliquée à la Dermatologie (CPCAD)

Nice, Nice Cedex 3, 06202, France

Location

MeSH Terms

Interventions

calcipotriene; betamethasone dipropionate, calcipotriol drug combination

Study Officials

• Catherine Queille-Roussel, MD

  Centre de harmacologie Clinique Appliquée à la Dermatologie (CPCAD), 06202 Nice Cedex 3, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 23, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 24, 2025

Record last verified: 2013-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)