Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456480
• Other study ID #: CLS001-CO-PR-008
• Secondary ID: 2014-003689-26
• Status: Completed
• Phase: Phase 2
• First received: May 1, 2015
• Last updated: July 25, 2016
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: July 2016
• Source: Cutanea Life Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male and female subjects with mild to moderate AD 18 to 65 years of age, inclusive.

2. AD diagnosed by physician / medical specialist and that has been (intermittently) present for at least 1 year

3. Able to participate and willing to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

1. Have any current and / or recurrent clinically significant skin condition in the treatment area other than AD.

2. Any confirmed, active significant allergic reactions (urticaria or anaphylaxis) including allergic reactions against any drug, multiple drug allergies or (ingredients of) emollients.

3. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• CLS001
topical gel
• Vehicle
topical gel

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research	Zernikedreef 8

Sponsors (1)

Lead Sponsor	Collaborator
Cutanea Life Sciences, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	42 Days	No
Primary	Clinical assessment (Change in patient symptoms over time using pruritis VAS)	Change in patient symptoms over time using pruritis VAS	42 Days	No
Primary	Clinical Assessment (Change in lesion size over time)	Change in lesion size over time	42 Days	Yes
Primary	Clinical assessment (Change in patient SCORAD scale score over time)	Change in patient SCORAD scale score over time	42 Days	No
Secondary	Safety Assessment (Adverse events)	Adverse events will be collected throughout the study	42 days	No