Skip to main content
OpenTrials
Completed

NCT Number: NCT02456480

Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients with mild to moderate atopic dermatitis (AD).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic 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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre for Human Drug Research

Zernikedreef 8, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female subjects with mild to moderate AD 18 to 65 years of age, inclusive.
  • AD diagnosed by physician / medical specialist and that has been (intermittently) present for at least 1 year
  • Able to participate and willing to give written informed consent and to comply with the study restrictions.

Exclusion criteria

  • Have any current and / or recurrent clinically significant skin condition in the treatment area other than AD.
  • Any confirmed, active significant allergic reactions (urticaria or anaphylaxis) including allergic reactions against any drug, multiple drug allergies or (ingredients of) emollients.
  • Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.

Treatment and study plan

CLS001

Drug

topical gel

Vehicle

Drug

topical gel

Primary outcomes

  1. Pharmacodynamic (Local punch biopsy of a target lesion pre-dose and post treatment for the change in biomarkers including IL, filaggrin, TLR, IgE, IFN, and microbiome of the skin lesion)

    Time frame: 42 Days

    Local punch biopsy of a target lesion pre-dose and post treatment for the change in biomarkers including IL, filaggrin, TLR, IgE, IFN, and microbiome of the skin lesion

  2. Clinical assessment (Change in patient symptoms over time using pruritis VAS)

    Time frame: 42 Days

    Change in patient symptoms over time using pruritis VAS

  3. Clinical Assessment (Change in lesion size over time)

    Time frame: 42 Days

    Change in lesion size over time

  4. Clinical assessment (Change in patient SCORAD scale score over time)

    Time frame: 42 Days

    Change in patient SCORAD scale score over time

Secondary outcomes

  1. Safety Assessment (Adverse events)

    Time frame: 42 days

    Adverse events will be collected throughout the study

Sponsors and collaborators

Lead sponsor

Maruho Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo Controlled Study to Assess the Pharmacodynamics, Safety/Tolerability and Efficacy of Omiganan in Patients With Mild to Moderate Atopic Dermatitis

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 28, 2015
Registry last updated
Jul 28, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.