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

Maruho

Status and phase: Unknown; Phase 2

Conditions: Seborrheic Dermatitis

Treatments: Drug: Omiganan; Drug: Placebo; Drug: Ketoconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03688971

CLS001-CO-PR-017

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

Omiganan Topical Gel

Experimental group

Description:

Omiganan 1.75%

Treatment:

Drug: Omiganan

Ketoconazole Topical Cream

Active Comparator group

Description:

Ketoconazole 2.0%

Treatment:

Drug: Ketoconazole

Vehicle

Placebo Comparator group

Treatment:

Drug: Placebo