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

Overview

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

Full Title of Study: “An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2015

Detailed Description

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

Interventions

  • Drug: Pimecrolimus cream
  • Drug: Betamethasone dipropionate cream
  • Drug: Clobetasol propionate cream
  • Drug: Glaxal Base cream vehicle

Arms, Groups and Cohorts

  • Active Comparator: Pimecrolimus cream
    • Pimecrolimus 1% cream once daily for 14 days
  • Active Comparator: Betamethasone dipropionate cream
    • Betamethasone dipropionate 0.05% cream once daily for 14 days
  • Active Comparator: Clobetasol propionate cream
    • Clobetasol propionate 0.05% cream once daily for 14 days
  • Placebo Comparator: Glaxal Base cream vehicle
    • Glaxal Base cream vehicle once daily for 14 days

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • LEO Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Emma Guttmann, MD, Principal Investigator, Icahn School of Medicine

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