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CompletedNCT01837576Updated Feb 24, 2025

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

A Phase 1 interventional study of Calcipotriol plus BDP gel in different doses in Psoriasis Vulgaris, sponsored by LEO Pharma. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by LEO Pharma · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis Vulgaris

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Keywords

  • Psoriasis Vulgaris
  • Calcipotriol
  • Betamethasone Dipropionate
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 24 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Subjects who have accepted biopsies with a positive Hepatitis B, Hepatitis C or HIV test
  • Subjects who have received treatment with any non marketed drug substance within the 4 week period prior to randomisation or longer, if the class of the substancerequires a longer washout as defined above
  • Subjects with current participation in any other interventional clinical
  • Subjects with known or suspected hypersensitivity to component(s) of the investigational products.
  • Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis on the test areas.
  • Subjects foreseeing an intensive solar exposure during the study or having been exposed within two weeks preceding the screening visit.
  • Subjects who have accepted the biopsies with any contraindication to skin biopsy procedures.
  • Subjects impossible to contact in case of emergency.
  • In the opinion of the investigator, subjects are unlikely to comply with the Clinical Study Protocol.
  • Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomization.
  • Subject under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom.
  • Subjects previously randomised in this trial.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Calcipotriol plus BDP gel in different doses

    A-E: calcipotriol, BDP gel in different concentrations

    Drug: Calcipotriol plus BDP gel in different doses

Interventions

  • DrugCalcipotriol plus BDP gel in different doses

    Topical , Once daily, 3 weeks

    Also known as: Daivobet gel

06

What researchers measure

Primary outcomes

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

    Time frame: 3 weeks

Secondary outcomes

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

    Time frame: 3 weeks

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

    Time frame: 3 weeks

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

    Time frame: 3 weeks

07

Study locations

1 site
  • Centre de harmacologie Clinique Appliquée à la Dermatologie (CPCAD)
    Nice, Nice Cedex 3 06202, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01837576
Lead sponsor
LEO Pharma
Responsible party
Sponsor
First posted
Apr 23, 2013
Start date
Apr 2013
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Feb 24, 2025

Study contacts

Catherine Queille-Roussel, MD
principal investigator · Centre de harmacologie Clinique Appliquée à la Dermatologie (CPCAD), 06202 Nice Cedex 3, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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