Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers

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Maruho

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Omiganan 2.5% and Imiquimod
Drug: Placebo
Drug: Omiganan
Drug: Imiquimod
Drug: Omiganan 1% and Imiquimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT03071679
CLS001-CO-PR-015
2016-004702-34 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

16 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

16 participants in 5 patient groups, including a placebo group

Omiganan
Experimental group
Treatment:
Drug: Omiganan
Imiquimod
Experimental group
Treatment:
Drug: Imiquimod
Omiganan 1% and Imiquimod
Experimental group
Treatment:
Drug: Omiganan 1% and Imiquimod
Omiganan 2.5% and Imiquimod
Experimental group
Treatment:
Drug: Omiganan 2.5% and Imiquimod
Placebo
Placebo Comparator group
Description:
Vehicle
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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