Pharmacodynamics of Omiganan BID 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 BID in Patients With Mild to Moderate Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091426
• Other study ID #: CLS001-CO-PR-014
• Secondary ID: 2016-003849-28
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2017
• Last updated: December 22, 2017
• Start date: March 8, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: December 2017
• Source: Cutanea Life Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study has a randomized, double-blind, placebo-controlled design to assess the efficacy, pharmacodynamics and safety/tolerability of omiganan in patients with mild to moderate atopic dermatitis when applied BID to all atopic dermatitis lesions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 65 years of age,inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;

• Confirmed AD diagnosis;

• Symptoms present for at least 1 year;

• EASI between 7.1 - 50.0, inclusive at screening;

• 2-20% body surface area (BSA) affected at screening;

• Body mass index (BMI) between 18 and 35 kg/m2, inclusive, and with a minimum weight of 50 kg;

• Able to participate and willing to give written informed consent and to comply with the study restrictions;

• Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.

Exclusion Criteria:

• Any current and / or recurrent clinical significant skin condition other than AD;

• Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;

• Ongoing use of prohibited atopic dermatitis treatments. Requires washout period prior to baseline (first dose of the study drug);

• Use of topical medication (prescription or over-the-counter [OTC]) within 14 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area;

• Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;

• Known hypersensitivity to the compound or excipients of the compound or known hypersensitivity to one or more different emollients;

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

• Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Omiganan
Omiganan 1%
• Omiganan
Omiganan 1.75%
• Omiganan
Omiganan 2.5%
• Placebo
Vehicle

Locations

Country	Name	City	State
Netherlands	LUMC/Centre for Human Drug Research	Leiden

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	Clinical Evaluation (oSCORAD)	oSCORAD Assessment	Within 7 Weeks
Primary	Clinical Evaluation (EASI)	EASI Assessment	Within 7 Weeks
Primary	Clinical Evaluation (IGA)	IGA Assessment	Within 7 Weeks
Primary	Patient-Orientated Outcome Measure (POEM)	Patient Assessment by collecting POEM	Within 7 Weeks
Primary	Dermatology Life Quality Index (DLQI)	Assessment of health-related quality of life by measuring DLQI	Within 7 Weeks
Primary	eDiary	Singe-Question assessment of pruritus and sleeplessness	Within 4 Weeks
Primary	Clinical Photography	Whole body photograph for qualitative and observational record	Within 7 Weeks
Primary	Pharmacodynamics (Biomarkers)	Local biomarkers sequencing	Within 7 Weeks
Primary	Pharmacodynamics (Microbiome)	Microbiome analysis	Within 7 Weeks
Primary	Pharmacodynamics (Microbiology)	Microbiology analysis	Within 7 Weeks
Primary	Pharmacodynamics (TEWL)	Transepidermal water-loss assessment	Within 7 Weeks
Primary	Pharmacodynamics (Thermography)	Skin temperature measurements will be taken	Within 7 Weeks
Primary	Pharmacodynamics (TAP)	Analysis of biomarkers captured by Transdermal Analysis Patch	Within 7 Weeks
Primary	Pharmacodynamics (Cytokines)	Cytokine assessment via blood evaluation	Within 7 Weeks
Secondary	Safety (AE)	Adverse Events will be collected throughout the study	Within 7 Weeks
Secondary	Safety (Vital Signs)	Vital Signs will be collected throughout the study	Within 7 Weeks
Secondary	Safety (Clinical Laboratory Tests)	Lab samples collected in various timepoints within the study	Within 7 Weeks
Secondary	Safety (ECG)	ECGs collected before beginning and end of study	Within 7 Weeks