Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis

Last updated: April 29, 2019
Sponsor: Maruho Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Seborrheic Dermatitis

Seborrhea

Eczema (Atopic Dermatitis - Pediatric)

Treatment

N/A

Clinical Study ID

NCT03688971
CLS001-CO-PR-017
  • Ages 18-100
  • All Genders

Study Summary

To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Confirmed SD diagnosis by dermatologist

  • Significant facial SD affected area as judged by the investigator or medicallyqualified designee

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

  • Willing to refrain from using other SD treatments in the local treatment area

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

Exclusion

Exclusion Criteria:

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

  • Ongoing use of prohibited SD medication. Washout periods prior to baseline are asfollows;

  1. Topical steroids, antibiotics, antifungals or other topical (OTC) therapies: 2weeks

  2. Systemic steroids, antibiotics, antifungals or other systemic therapies: 4 weeks;

  3. Phototherapy: 3 weeks;

  4. Regular use of shampoo for the treatment of PC (including but not limited to OTCzinc pyrithione shampoo), soap for the treatment of seborrheic dermatitis: 2weeks

  5. Changing a soap, method for daily facial and hair washing: 1 week

  • Known hypersensitivity to the compounds or excipients of the compounds;

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

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

  • Participation in an investigational drug or device study within 3 months prior toscreening or more than 4 times in the past year;

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

Study Design

Total Participants: 36
Study Start date:
October 22, 2018
Estimated Completion Date:
December 31, 2019

Connect with a study center

  • Centre for Human Drug Research

    Leiden,
    Netherlands

    Active - Recruiting

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