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

LEO Pharma30 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

Pimecrolimus creamDRUG

Betamethasone dipropionate creamDRUG

Clobetasol propionate creamDRUG

Glaxal Base cream vehicleDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Innovaderm Research Inc.

Montreal, Quebec, Canada

Beit Harofim

Netanya, Israel

Outcomes

Primary Outcomes

Total Sign Score (TSS) change

TSS change at end of treatment in relation to baseline

Time frame: 14 days

Data from ClinicalTrials.gov

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