An Exploratory Psoriasis Plaque Test Study With LEO 29102 Plus Calcipotriol, Ointment, in Psoriasis Vulgaris

NCT01466478 | Completed Phase 1

• 2 other identifiers: PLQ-0072011-003058-25
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare the 3 ointment formulations containing LEO 29102 plus calcipotriol and Daivonex® ointment and Diprosone® ointment and to compare LEO 29102 plus calcipotriol to LEO 29102 alone and to calcipotriol alone in the same ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Change from baseline to end of treatment in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration).

  TCS range from 0 (all symptoms absent) to 9 (all symptoms severe)

  4 weeks

Secondary Outcomes (3)

• Clinical criteria: - Change from baseline in single clinical symptom score: erythema, scaling, infiltration at end of treatment and individual visits, - Change from baseline in Total Clinical Score (TCS) at individual visits.

  4 weeks

• Ultrasonography: Change from baseline to end of treatment in lesion thickness (total and echo-poor band) measured by ultrasound.

  4 weeks

• NIR spectroscopy: Change from baseline to Day 15 and end of treatment in the ratio between the peaks at 6900 cm-1 and at 5200 cm-1, the width of the peak at 6900 cm-1 and the calculated severity score

  4 weeks

Study Arms (1)

LEO 29102 plus calcipotriol

EXPERIMENTAL

Drug: Ointment A: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment; Drug: Ointment B: LEO 29102 2.5 mg/g ointment; Drug: Ointment C: Calcipotriol 50 µg/g ointment; Drug: Ointment D: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment; Drug: Ointment G: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment; Drug: Daivonex® ointment; Drug: Diprosone® ointment

Interventions

Ointment A: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment DRUG

once daily application, 4 weeks

LEO 29102 plus calcipotriol

Ointment B: LEO 29102 2.5 mg/g ointment DRUG

once daily application, 4 weeks

LEO 29102 plus calcipotriol

Ointment C: Calcipotriol 50 µg/g ointment DRUG

once daily application, 4 weeks

LEO 29102 plus calcipotriol

Ointment D: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment DRUG

once daily application, 4 weeks

LEO 29102 plus calcipotriol

Ointment G: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment DRUG

once daily application, 4 weeks

LEO 29102 plus calcipotriol

Daivonex® ointment DRUG

once daily application, 4 weeks

LEO 29102 plus calcipotriol

Diprosone® ointment DRUG

once daily application, 4 weeks

LEO 29102 plus calcipotriol

Eligibility Criteria

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

You may qualify if:

• Following verbal and written information about the trial, the subject has to provide signed and dated informed consent before any study related activities are carried out.
• Age 18 years or above.
• Either sex.
• All skin types.
• Outpatients with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 7 different products.
• Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (Baseline).
• Subjects with psoriasis lesions (plaques) assessed by a Total Clinical Score (sum of scores of erythema, scaling and infiltration) of 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 subjects of childbearing potential using a reliable method of contraception for at least 1 month before the study start and during the course of the study (e.g., oral contraceptive pill, intrauterine device, contraceptive patches, implantable contraception, condoms) or females of non childbearing potential (i.e. postmenopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral ovariectomy or tubal section/ligation).
• Female with a negative urine pregnancy test at Visit 1 (screening visit).

You may not qualify if:

• Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding.
• Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation and during the study.
• Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the study.
• Use of phototherapy within the following time periods 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 the 4 week period prior to randomisation and during the study:
• Potent or very potent (WHO group III-IV) corticosteroids.
• 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 for treatment of scalp and/or facial psoriasis),
• Topical retinoids,
• Vitamin D analogues,
• Topical immunomodulators (e.g. macrolides),
• Anthracen derivatives,
• Tar,

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

CPCAD - Centre de Pharmacologie Clinique Appliquée à la Dermatologie

Nice, 06202, France

Location

MeSH Terms

Interventions

calcipotriene; Ointments

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Catherine Queille-Roussel, MD

  Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

  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: October 26, 2011
• First Posted: November 8, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 24, 2025

Record last verified: 2013-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)