NCT01935869

Brief Summary

The purpose of this study is to determine the skin irritation potential and sensitisation potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 24, 2025

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

August 27, 2013

Last Update Submit

February 21, 2025

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

  • Mean Cumulative Irritation index and maximal dermal response during induction phase

    3 weeks

  • Number of subjects with positive sensitisation reaction at each test site in the challenge phase

    6 weeks

Study Arms (3)

LEO 90100

EXPERIMENTAL
Drug: LEO 90100

Vehicle

PLACEBO COMPARATOR
Drug: Vehicle

Petrolatum ointment

OTHER
Drug: Petrolatum ointment

Interventions

LEO 90100DRUG
LEO 90100
VehicleDRUG
Vehicle
Petrolatum ointmentDRUG
Petrolatum ointment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Following verbal and written information about the trial, subject must provide signed and dated informed consent before any study related activities are carried out.
  • \. Healthy male or female subjects, 18 to 65 years of age inclusive at screening.

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
  • \. Subjects with any systemic or cutaneous disorder that might interfere with the evaluation of the test site reactions (e.g. atopic dermatitis, contact eczema, psoriasis) 3. Subjects with scars, moles or other abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital de l'Archet 2

Nice, 06202, France

Location

Related Publications (1)

  • Queille-Roussel C, Liljedahl M, Clonier F, Lacour JP. Phase I evaluation of the dermal safety of the fixed combination calcipotriene plus betamethasone dipropionate aerosol foam and foam vehicle. J Am Acad Dermatol. 2015:72 Suppl 1;AB211 (P844).

    RESULT

Related Links

Study Officials

  • Medical Expert

    LEO Pharma

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 5, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

February 24, 2025

Record last verified: 2015-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)