A Clinical Trial to Compare Topical Agents in Adults With... | NCT02376049

Studies
A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)

NCT02376049

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Feb 24, 2025Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Atopic Dermatitis

Interventions

Pimecrolimus cream
Betamethasone dipropionate cream
Clobetasol propionate cream
Glaxal Base cream vehicle

Countries

Canada
Israel

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

May 2017

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

Feb 2015

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Feb 25, 2015

First Submission Date that Met QC Criteria

Mar 2, 2015

First Posted Date

Mar 3, 2015Estimated

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

An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.

Detailed Description

Multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pimecrolimus cream	Active Comparator	Pimecrolimus 1% cream once daily for 14 days	Drug: Pimecrolimus cream
Betamethasone dipropionate cream	Active Comparator	Betamethasone dipropionate 0.05% cream once daily for 14 days	Drug: Betamethasone dipropionate cream
Clobetasol propionate cream	Active Comparator	Clobetasol propionate 0.05% cream once daily for 14 days	Drug: Clobetasol propionate cream
Glaxal Base cream vehicle	Placebo Comparator	Glaxal Base cream vehicle once daily for 14 days	Drug: Glaxal Base cream vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pimecrolimus cream	Drug		Pimecrolimus cream	Elidel
Betamethasone dipropionate cream

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Sign Score (TSS) change	TSS change at end of treatment in relation to baseline	14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject with mild to moderate AD
Four comparable TAs
TSS of at least 5 on all TAs
Difference in TSS not greater than 2 between the TAs
Sign score erythema ≥ 2 between the TAs
TAs should be at least 2 cm apart

Exclusion Criteria:

Investigator's opinion
Fitzpatrick skin type >5
Topical (i.e. on the TAs) treatment with prohibited medications
Systemic treatment with prohibited medications
Phototherapy within prohibited timeframe
Use of emollients within prohibited timeframe

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emma Guttmann, MD	Icahn School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Innovaderm Research Inc.		Montreal	Quebec	H2K 4L5	Canada
Beit Harofim

Label	URL
Clinical Trials at LEO Pharma	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic
D004485	Eczema

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C117268	pimecrolimus
C011175	betamethasone-17,21-dipropionate
D002990	Clobetasol

Ancestor Terms

ID	Term
D001623	Betamethasone
D013259	Steroids, Fluorinated
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided