Back to resultsOmiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis
Primary Purpose
Seborrheic Dermatitis
Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Omiganan
Ketoconazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seborrheic Dermatitis
Eligibility 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.
Sites / Locations
- Centre for Human Drug ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Omiganan Topical Gel
Ketoconazole Topical Cream
Vehicle
Arm Description
Omiganan 1.75%
Ketoconazole 2.0%
Outcomes
Primary Outcome Measures
Seborrheic dermatitis area severity index (SDASI)
Assessment of erythema, scales and papules and each are scored as 0=none to 3=severe.
Investigator global assessment (IGA)
This is a 5-point scale ranging from 0=clear to 4=severe.
Area of involvement
Facial area involvement is estimated as a % of the body surface area (BSA)
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.
PRO - 5-D itch scale
Multidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution.
PRO - dermatology life quality index (DLQI)
Asses health-related quality of life in general dermatology disability index
Standardized photography
Facial photographs will be taken by a 2D camera (VISIA-CR)
Sebum measurements
Measurement of sebum excretion by Sebumeter
Trans Epidermal Water Loss (TEWL)
To assess barrier status of lesional and non-lesional skin.
Optical Coherence Tomography (OCT)
Measurement of cutaneous morphology of seborrheic dermatitis
Liquid chromatography-mass spectrometry (LC-MS)
Will evaluate the changes in lipid composition of stratum corneum (SC).
Secondary Outcome Measures
Skin microbiota
collection of skin culture sample to evaluate skin microbiota
Skin mycobiota
collection of skin culture sample to evaluate skin mycobiota
Faecal microbiome
collection of faecal samples to evaluate faecal microbiome
Adverse events collected throughout the study
Vital signs performed at screening and end of study
Evaluation of systolic and diastolic blood pressure
Vital signs performed at screening and end of study
Evaluation of pulse rate
Vital signs performed at screening and end of study
Evaluation of temperature
12-Lead ECGs performed at screening and end of study
Assessment of heart rate
12-Lead ECGs performed at screening and end of study
Assessment of PR, QRS, QT, QTcB and QTcF
Haematology blood sample assessment
Evaluation of blood collected in BD Vacutainer K2EDTA tube.
Chemistry blood sample assessment
Evaluation of blood collected in BD Vacutainer SST Gel and Clot Activator tube.
Urinalysis urine sample assessment
Evaluation of urine specimen by dipstick
Collection of concomitant medications
questionnaire at each visit to collect concomitant medications taken
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03688971
Brief Title
Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omiganan Topical Gel
Arm Type
Experimental
Arm Description
Omiganan 1.75%
Arm Title
Ketoconazole Topical Cream
Arm Type
Active Comparator
Arm Description
Ketoconazole 2.0%
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Omiganan
Intervention Description
Omiganan Topical Gel
Intervention Type
Drug
Intervention Name(s)
Ketoconazole
Intervention Description
Ketoconazole Cream
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle
Primary Outcome Measure Information:
Title
Seborrheic dermatitis area severity index (SDASI)
Description
Assessment of erythema, scales and papules and each are scored as 0=none to 3=severe.
Time Frame
6 Weeks
Title
Investigator global assessment (IGA)
Description
This is a 5-point scale ranging from 0=clear to 4=severe.
Time Frame
6 Weeks
Title
Area of involvement
Description
Facial area involvement is estimated as a % of the body surface area (BSA)
Time Frame
6 Weeks
Title
Patient Reported Outcome (PRO) - eDiary
Description
Single-question assessment regarding patient's worst itch. On a scale of 0-100, 0=no itch and 100=worst itch.
Time Frame
4 Weeks
Title
PRO - 5-D itch scale
Description
Multidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution.
Time Frame
6 Weeks
Title
PRO - dermatology life quality index (DLQI)
Description
Asses health-related quality of life in general dermatology disability index
Time Frame
6 Weeks
Title
Standardized photography
Description
Facial photographs will be taken by a 2D camera (VISIA-CR)
Time Frame
6 Weeks
Title
Sebum measurements
Description
Measurement of sebum excretion by Sebumeter
Time Frame
6 Weeks
Title
Trans Epidermal Water Loss (TEWL)
Description
To assess barrier status of lesional and non-lesional skin.
Time Frame
6 Weeks
Title
Optical Coherence Tomography (OCT)
Description
Measurement of cutaneous morphology of seborrheic dermatitis
Time Frame
6 Weeks
Title
Liquid chromatography-mass spectrometry (LC-MS)
Description
Will evaluate the changes in lipid composition of stratum corneum (SC).
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Skin microbiota
Description
collection of skin culture sample to evaluate skin microbiota
Time Frame
6 Weeks
Title
Skin mycobiota
Description
collection of skin culture sample to evaluate skin mycobiota
Time Frame
6 Weeks
Title
Faecal microbiome
Description
collection of faecal samples to evaluate faecal microbiome
Time Frame
4 Weeks
Title
Adverse events collected throughout the study
Time Frame
6 Weeks
Title
Vital signs performed at screening and end of study
Description
Evaluation of systolic and diastolic blood pressure
Time Frame
6 Weeks
Title
Vital signs performed at screening and end of study
Description
Evaluation of pulse rate
Time Frame
6 Weeks
Title
Vital signs performed at screening and end of study
Description
Evaluation of temperature
Time Frame
6 Weeks
Title
12-Lead ECGs performed at screening and end of study
Description
Assessment of heart rate
Time Frame
6 Weeks
Title
12-Lead ECGs performed at screening and end of study
Description
Assessment of PR, QRS, QT, QTcB and QTcF
Time Frame
6 Weeks
Title
Haematology blood sample assessment
Description
Evaluation of blood collected in BD Vacutainer K2EDTA tube.
Time Frame
6 Weeks
Title
Chemistry blood sample assessment
Description
Evaluation of blood collected in BD Vacutainer SST Gel and Clot Activator tube.
Time Frame
6 Weeks
Title
Urinalysis urine sample assessment
Description
Evaluation of urine specimen by dipstick
Time Frame
6 Weeks
Title
Collection of concomitant medications
Description
questionnaire at each visit to collect concomitant medications taken
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Rissmann, PhD
Phone
+ 31 (0) 71 5246 400
Email
clintrials@chdr.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Rissmann, PhD
Organizational Affiliation
Centre for Human Drug Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Human Drug Research
City
Leiden
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Rissmann, PhD
Phone
+ 31(0) 71 5246 400
Email
clintrial@chdr.nl
First Name & Middle Initial & Last Name & Degree
Robert Rissmann, PhD
12. IPD Sharing Statement
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Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis
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