Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Randomized, Evaluator-blinded, Vehicle-controlled Study to Explore the Pharmacodynamic Effects of Omiganan and Omiganan in Combination With Imiquimod in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071679
• Other study ID #: CLS001-CO-PR-015
• Secondary ID: 2016-004702-34
• Status: Completed
• Phase: Phase 1
• First received: February 21, 2017
• Last updated: May 19, 2017
• Start date: February 6, 2017
• Est. completion date: March 7, 2017

Study information

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

Clinical Trial Summary

This study has a randomized, evaluator-blinded, vehicle- controlled study to assess the pharmacodynamics of omiganan and omiganan with imiquimod in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 7, 2017
• Est. primary completion date: March 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy male and female subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, blood serology and urinalysis.

• Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg.

• Fitzpatrick skin type I-III (Caucasian)

• 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.

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

Exclusion Criteria:

• Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients

• Family history of psoriasis

• History of pathological scar formation (keloid, hypertrophic scar)

• Have any current and / or recurrent pathologically, clinical significant skin condition.

• Previous use of imiquimod/ resiquimod/ gardiquimod

• Known hypersensitivity to the (non)investigational drug, drugs of the same class, or any of their excipients.

• Hypersensitivity for dermatological marker at screening

• Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study.

• Use of topical medication (prescription or over-the-counter [OTC]) within 30 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.

• 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

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Omiganan
Omignan 1%, 2.5%
• Imiquimod
Imiquimod 15mg
• Omiganan 1% and Imiquimod
Omiganan 1% and Imiquimod
• Omiganan 2.5% and Imiquimod
Omiganan 2.5% and Imiquimod
• 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	Erythema grading scale	6 Days
Primary	Pharmacodynamic (Biomarkers)	Local biomarker sequencing	Within 2 Weeks
Primary	Pharmacodynamic (Histology)	Histological parameters assessment	Within 2 Weeks
Primary	Pharmacodynamic (Immunohistochemistry)	Identification of lymphocytes and lineage cells	Within 2 Weeks
Primary	Pharmacodynamic (TAP)	Qualitatively and Quantitatively analyze biomarkers captured by Trans Epidermal Patch (TAP)	Within 6 Days
Primary	pharmacodynamic (LSCI)	Assess cutaneous microcirculation using laster speckle imager	Within 6 Days
Primary	Pharmacodynamic (Colorimetry)	Colorimetric assessment by erythema grading scale	Within 6 Days
Primary	Pharmacodynamic (Photography)	Photographs of treatment sites will be taken	Within 2 Weeks
Primary	Pharmacodynamic (Thermography)	Skin temperature measurements will be taken	Within 2 Weeks
Secondary	Local tolerability	Visual Analogue Scale (NRS) pruritus and pain	2 Weeks
Secondary	Safety (AE)	Adverse Events will be collected throughout the study	2 Weeks
Secondary	Safety (Vital Signs)	Vital Signs will be collected throughout the study	2 Weeks
Secondary	Safety (Laboratory Safety Testing)	Lab samples collected in various timepoints within the study	2 Weeks
Secondary	Safety (ECG)	ECGs will be collected before beginning and end of study	Within 3 Weeks