A phase 2, randomized, vehicle and ketoconazole-controlled, evaluator-blinded, study to explore the efficacy, pharmacodynamics and safety of omiganan 1.75% topical gel BID in patients with mild to moderate facial seborrheic dermatitis.

Phase 2

Completed

• Conditions: seborrheic dermatitis; seborrhoea; 10040790

• Registration Number: NL-OMON48780
• Lead Sponsor: Maruho Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

For enrollment of subjects the following criteria must be met:
1. 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;
2. Confirmed SD diagnosis by dermatologist
3. Significant facial SD affected area as judged by the investigator or
medically qualified designee.
4. Able to participate and willing to give written informed consent and to
comply with the study restrictions;
5. Willing to refrain from using other SD treatments in the local treatment area
6. 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

Eligible subjects must meet none of the following exclusion criteria:
1. Any current and / or recurrent clinical significant skin condition other
than SD;
2. Ongoing use of prohibited SD medication. Washout periods prior to baseline
are as follows;
a. Topical steroids, antibiotics, antifungals or other (OTC) topical therapies:
2 weeks
b. Systemic steroids, antibiotics, antifungals or other systemic therapies: 4
weeks;
c. Phototherapy: 3 weeks;
d. 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
e. Changing a soap, method for daily facial and hair washing: 1 week
3. Known hypersensitivity to the compounds or excipients of the compounds;
4. Tanning due to sunbathing, excessive sun exposure or a tanning booth within
3 weeks of enrollment;
5. Pregnant, a positive pregnancy test, intending to become pregnant, or
breastfeeding;
6. Participation in an investigational drug or device study within 3 months
prior to screening or more than 4 times in the past year;
7. Loss or donation of blood over 500 mL within three months (males) or four
months (females) prior to screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified