Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis
Study Details
Study Description
Brief Summary
To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Omiganan Topical Gel Omiganan 1.75% |
Drug: Omiganan
Omiganan Topical Gel
|
| Active Comparator: Ketoconazole Topical Cream Ketoconazole 2.0% |
Drug: Ketoconazole
Ketoconazole Cream
|
| Placebo Comparator: Vehicle
|
Drug: Placebo
Vehicle
|
Outcome Measures
Primary Outcome Measures
- Seborrheic dermatitis area severity index (SDASI) [6 Weeks]
Assessment of erythema, scales and papules and each are scored as 0=none to 3=severe.
- Investigator global assessment (IGA) [6 Weeks]
This is a 5-point scale ranging from 0=clear to 4=severe.
- Area of involvement [6 Weeks]
Facial area involvement is estimated as a % of the body surface area (BSA)
- Patient Reported Outcome (PRO) - eDiary [4 Weeks]
Single-question assessment regarding patient's worst itch. On a scale of 0-100, 0=no itch and 100=worst itch.
- PRO - 5-D itch scale [6 Weeks]
Multidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution.
- PRO - dermatology life quality index (DLQI) [6 Weeks]
Asses health-related quality of life in general dermatology disability index
- Standardized photography [6 Weeks]
Facial photographs will be taken by a 2D camera (VISIA-CR)
- Sebum measurements [6 Weeks]
Measurement of sebum excretion by Sebumeter
- Trans Epidermal Water Loss (TEWL) [6 Weeks]
To assess barrier status of lesional and non-lesional skin.
- Optical Coherence Tomography (OCT) [6 Weeks]
Measurement of cutaneous morphology of seborrheic dermatitis
- Liquid chromatography-mass spectrometry (LC-MS) [6 Weeks]
Will evaluate the changes in lipid composition of stratum corneum (SC).
Secondary Outcome Measures
- Skin microbiota [6 Weeks]
collection of skin culture sample to evaluate skin microbiota
- Skin mycobiota [6 Weeks]
collection of skin culture sample to evaluate skin mycobiota
- Faecal microbiome [4 Weeks]
collection of faecal samples to evaluate faecal microbiome
- Adverse events collected throughout the study [6 Weeks]
- Vital signs performed at screening and end of study [6 Weeks]
Evaluation of systolic and diastolic blood pressure
- Vital signs performed at screening and end of study [6 Weeks]
Evaluation of pulse rate
- Vital signs performed at screening and end of study [6 Weeks]
Evaluation of temperature
- 12-Lead ECGs performed at screening and end of study [6 Weeks]
Assessment of heart rate
- 12-Lead ECGs performed at screening and end of study [6 Weeks]
Assessment of PR, QRS, QT, QTcB and QTcF
- Haematology blood sample assessment [6 Weeks]
Evaluation of blood collected in BD Vacutainer K2EDTA tube.
- Chemistry blood sample assessment [6 Weeks]
Evaluation of blood collected in BD Vacutainer SST Gel and Clot Activator tube.
- Urinalysis urine sample assessment [6 Weeks]
Evaluation of urine specimen by dipstick
- Collection of concomitant medications [6 Weeks]
questionnaire at each visit to collect concomitant medications taken
Eligibility Criteria
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;
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre for Human Drug Research | Leiden | Netherlands |
Sponsors and Collaborators
- Maruho Co., Ltd.
Investigators
- Principal Investigator: Robert Rissmann, PhD, Centre for Human Drug Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLS001-CO-PR-017