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

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

Official Title
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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

Conditions
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Seborrheic Dermatitis

Intervention / Treatment
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* Drug: Omiganan
* Drug: Ketoconazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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; Topical steroids, antibiotics, antifungals or other topical (OTC) therapies: 2 weeks Systemic steroids, antibiotics, antifungals or other systemic therapies: 4 weeks; Phototherapy: 3 weeks; 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omiganan Topical Gel<br>Omiganan 1.75% | Drug: Omiganan<br>* Omiganan Topical Gel<br>|
| Active Comparator: Ketoconazole Topical Cream<br>Ketoconazole 2.0% | Drug: Ketoconazole<br>* Ketoconazole Cream<br>|
| Placebo Comparator: Vehicle<br> | Drug: Placebo<br>* Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seborrheic dermatitis area severity index (SDASI) | Assessment of erythema, scales and papules and each are scored as 0=none to 3=severe. | 6 Weeks | 
| Investigator global assessment (IGA) | This is a 5-point scale ranging from 0=clear to 4=severe. | 6 Weeks | 
| Area of involvement | Facial area involvement is estimated as a % of the body surface area (BSA) | 6 Weeks | 
| Patient Reported Outcome (PRO) - eDiary | Single-question assessment regarding patient's worst itch. On a scale of 0-100, 0=no itch and 100=worst itch. | 4 Weeks | 
| PRO - 5-D itch scale | Multidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution. | 6 Weeks | 
| PRO - dermatology life quality index (DLQI) | Asses health-related quality of life in general dermatology disability index | 6 Weeks | 
| Standardized photography | Facial photographs will be taken by a 2D camera (VISIA-CR) | 6 Weeks | 
| Sebum measurements | Measurement of sebum excretion by Sebumeter | 6 Weeks | 
| Trans Epidermal Water Loss (TEWL) | To assess barrier status of lesional and non-lesional skin. | 6 Weeks | 
| Optical Coherence Tomography (OCT) | Measurement of cutaneous morphology of seborrheic dermatitis | 6 Weeks | 
| Liquid chromatography-mass spectrometry (LC-MS) | Will evaluate the changes in lipid composition of stratum corneum (SC). | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin microbiota | collection of skin culture sample to evaluate skin microbiota | 6 Weeks | 
| Skin mycobiota | collection of skin culture sample to evaluate skin mycobiota | 6 Weeks | 
| Faecal microbiome | collection of faecal samples to evaluate faecal microbiome | 4 Weeks | 
| Adverse events collected throughout the study |  | 6 Weeks | 
| Vital signs performed at screening and end of study | Evaluation of systolic and diastolic blood pressure | 6 Weeks | 
| Vital signs performed at screening and end of study | Evaluation of pulse rate | 6 Weeks | 
| Vital signs performed at screening and end of study | Evaluation of temperature | 6 Weeks | 
| 12-Lead ECGs performed at screening and end of study | Assessment of heart rate | 6 Weeks | 
| 12-Lead ECGs performed at screening and end of study | Assessment of PR, QRS, QT, QTcB and QTcF | 6 Weeks | 
| Haematology blood sample assessment | Evaluation of blood collected in BD Vacutainer K2EDTA tube. | 6 Weeks | 
| Chemistry blood sample assessment | Evaluation of blood collected in BD Vacutainer SST Gel and Clot Activator tube. | 6 Weeks | 
| Urinalysis urine sample assessment | Evaluation of urine specimen by dipstick | 6 Weeks | 
| Collection of concomitant medications | questionnaire at each visit to collect concomitant medications taken | 6 Weeks |