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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cutanea Life Sciences, Inc.; Maruho Co., Ltd.
• Treatments: Ketoconazole

Criteria

Inclusion Criteria:

• Male and female subjects with mild to moderate facial SD (IGA 2 or 3), ≥18 years of age, inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than SD following a detailed medical 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 medically qualified designee

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

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

• 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 SD;

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

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

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 OTC zinc pyrithione shampoo), soap for the treatment of seborrheic dermatitis: 2 weeks

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 of enrollment;

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

• Participation in an investigational drug or device study within 3 months prior to screening 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.