Combined Cumulative Irritation Potential and Repeat Insul... | NCT01935869

Studies
Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100

NCT01935869

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Feb 24, 2025Actual

Enrollment

224Actual

Phase

Phase 1

Conditions

Psoriasis Vulgaris

Interventions

LEO 90100
Vehicle
Petrolatum ointment

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Nov 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Aug 27, 2013

First Submission Date that Met QC Criteria

Sep 2, 2013

First Posted Date

Sep 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2025

Last Update Posted Date

Feb 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

224Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
LEO 90100	Experimental	Drug: LEO 90100
Vehicle	Placebo Comparator	Drug: Vehicle
Petrolatum ointment	Other	Drug: Petrolatum ointment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LEO 90100	Drug		LEO 90100
Vehicle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding
2. 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Expert	LEO Pharma	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital de l'Archet 2		Nice		06202	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	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).