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Completed

NCT Number: NCT02376049

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

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Innovaderm Research Inc., Montreal, Quebec, Canada

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pimecrolimus cream

Drug

Other names: Elidel

Betamethasone Dipropionate Cream

Drug

Other names: Diprosone, Diprolene

Clobetasol propionate cream

Drug

Other names: Dermovate

Glaxal Base cream vehicle

Drug

Other names: emollient cream

Primary outcomes

  1. Total Sign Score (TSS) change

    Time frame: 14 days

    TSS change at end of treatment in relation to baseline

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 3, 2015
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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