Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: CLS001; Drug: Vehicle

• Registration Number: NCT02456480
• Lead Sponsor: Maruho Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-28
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-07
• Disposition First Submitted: 2016-07-25
• Disposition First Submitted QC: 2016-07-25
• Last Update Submitted: 2016-07-25
• Disposition First Posted: 2016-07-28
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLS001 topical gel 1%	CLS001	-
Vehicle gel	Vehicle	-
CLS001 topical gel, 2.5%	CLS001	-

Primary Outcome Measures

Name	Time	Method
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)	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
Clinical assessment (Change in patient symptoms over time using pruritis VAS)	42 Days	Change in patient symptoms over time using pruritis VAS
Clinical Assessment (Change in lesion size over time)	42 Days	Change in lesion size over time
Clinical assessment (Change in patient SCORAD scale score over time)	42 Days	Change in patient SCORAD scale score over time

Secondary Outcome Measures

Name	Time	Method
Safety Assessment (Adverse events)	42 days	Adverse events will be collected throughout the study

Trial Locations

Locations (1)

Centre for Human Drug Research; 🇳🇱 Zernikedreef 8, Netherlands