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

NCT ID: NCT02376049

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-07-31

Brief Summary

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

Detailed Description

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

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pimecrolimus cream

Pimecrolimus 1% cream once daily for 14 days

Group Type ACTIVE_COMPARATOR

Pimecrolimus cream

Intervention Type DRUG

Betamethasone dipropionate cream

Betamethasone dipropionate 0.05% cream once daily for 14 days

Group Type ACTIVE_COMPARATOR

Betamethasone dipropionate cream

Intervention Type DRUG

Clobetasol propionate cream

Clobetasol propionate 0.05% cream once daily for 14 days

Group Type ACTIVE_COMPARATOR

Clobetasol propionate cream

Intervention Type DRUG

Glaxal Base cream vehicle

Glaxal Base cream vehicle once daily for 14 days

Group Type PLACEBO_COMPARATOR

Glaxal Base cream vehicle

Intervention Type DRUG

Interventions

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Pimecrolimus cream

Intervention Type DRUG

Betamethasone dipropionate cream

Intervention Type DRUG

Clobetasol propionate cream

Intervention Type DRUG

Glaxal Base cream vehicle

Intervention Type DRUG

Other Intervention Names

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Elidel Diprosone Diprolene Dermovate emollient cream

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emma Guttmann, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine

Locations

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Innovaderm Research Inc.

Montreal, Quebec, Canada

Site Status

Beit Harofim

Netanya, , Israel

Site Status

Countries

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Canada Israel

Related Links

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https://www.leopharmatrials.com/en

Clinical Trials at LEO Pharma

Other Identifiers

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EXP-1184

Identifier Type: -

Identifier Source: org_study_id

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