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Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03071679
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : May 22, 2017
Information provided by (Responsible Party):
Cutanea Life Sciences, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Omiganan Drug: Imiquimod Drug: Omiganan 1% and Imiquimod Drug: Omiganan 2.5% and Imiquimod Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : March 7, 2017
Actual Study Completion Date : March 7, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: Omiganan Drug: Omiganan
Omignan 1%, 2.5%

Experimental: Imiquimod Drug: Imiquimod
Imiquimod 15mg

Experimental: Omiganan 1% and Imiquimod Drug: Omiganan 1% and Imiquimod
Omiganan 1% and Imiquimod

Experimental: Omiganan 2.5% and Imiquimod Drug: Omiganan 2.5% and Imiquimod
Omiganan 2.5% and Imiquimod

Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. Clinical Evaluation [ Time Frame: 6 Days ]
    Erythema grading scale

  2. Pharmacodynamic (Biomarkers) [ Time Frame: Within 2 Weeks ]
    Local biomarker sequencing

  3. Pharmacodynamic (Histology) [ Time Frame: Within 2 Weeks ]
    Histological parameters assessment

  4. Pharmacodynamic (Immunohistochemistry) [ Time Frame: Within 2 Weeks ]
    Identification of lymphocytes and lineage cells

  5. Pharmacodynamic (TAP) [ Time Frame: Within 6 Days ]
    Qualitatively and Quantitatively analyze biomarkers captured by Trans Epidermal Patch (TAP)

  6. pharmacodynamic (LSCI) [ Time Frame: Within 6 Days ]
    Assess cutaneous microcirculation using laster speckle imager

  7. Pharmacodynamic (Colorimetry) [ Time Frame: Within 6 Days ]
    Colorimetric assessment by erythema grading scale

  8. Pharmacodynamic (Photography) [ Time Frame: Within 2 Weeks ]
    Photographs of treatment sites will be taken

  9. Pharmacodynamic (Thermography) [ Time Frame: Within 2 Weeks ]
    Skin temperature measurements will be taken

Secondary Outcome Measures :
  1. Local tolerability [ Time Frame: 2 Weeks ]
    Visual Analogue Scale (NRS) pruritus and pain

  2. Safety (AE) [ Time Frame: 2 Weeks ]
    Adverse Events will be collected throughout the study

  3. Safety (Vital Signs) [ Time Frame: 2 Weeks ]
    Vital Signs will be collected throughout the study

  4. Safety (Laboratory Safety Testing) [ Time Frame: 2 Weeks ]
    Lab samples collected in various timepoints within the study

  5. Safety (ECG) [ Time Frame: Within 3 Weeks ]
    ECGs will be collected before beginning and end of study

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03071679

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LUMC/Centre for Human Drug Research
Leiden, Netherlands
Sponsors and Collaborators
Cutanea Life Sciences, Inc.
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Principal Investigator: J. (Koos) Burggraaf, MD, PhD Centre for Human Drug Research

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Responsible Party: Cutanea Life Sciences, Inc. Identifier: NCT03071679     History of Changes
Other Study ID Numbers: CLS001-CO-PR-015
2016-004702-34 ( EudraCT Number )
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Antimicrobial Cationic Peptides
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers
Anti-Infective Agents