Seborrheic DermatitisPhase 2NCT03688971
Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis
A Phase 2 study testing Omiganan and Ketoconazole in people with Seborrheic Dermatitis, run by Maruho Co., Ltd. at 1 site in Netherlands.
Trial summary
To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- Omiganan and Ketoconazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Oct 2018to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Centre for Human Drug Research
Leiden
Robert Rissmann, PhD, + 31(0) 71 5246 400, clintrial@chdr.nl
Robert Rissmann, PhD
About this study
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
To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis.
- Conditions
- Seborrheic Dermatitis
- Being tested
- Omiganan, Ketoconazole, Placebo
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmigananDrug
Omiganan Topical Gel
KetoconazoleDrug
Ketoconazole Cream
PlaceboDrug
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| Omiganan Topical Gel | Experimental | Omiganan 1.75% Receives: Drug: Omiganan |
| Ketoconazole Topical Cream | Active comparator | Ketoconazole 2.0% Receives: Drug: Ketoconazole |
| Vehicle | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seborrheic dermatitis area severity index (SDASI)
Assessment of erythema, scales and papules and each are scored as 0=none to 3=severe.
Measured: 6 Weeks
Investigator global assessment (IGA)
This is a 5-point scale ranging from 0=clear to 4=severe.
Measured: 6 Weeks
Area of involvement
Facial area involvement is estimated as a % of the body surface area (BSA)
Measured: 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.
Measured: 4 Weeks
PRO - 5-D itch scale
Multidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution.
Measured: 6 Weeks
PRO - dermatology life quality index (DLQI)
Asses health-related quality of life in general dermatology disability index
Measured: 6 Weeks
Standardized photography
Facial photographs will be taken by a 2D camera (VISIA-CR)
Measured: 6 Weeks
Sebum measurements
Measurement of sebum excretion by Sebumeter
Measured: 6 Weeks
Trans Epidermal Water Loss (TEWL)
To assess barrier status of lesional and non-lesional skin.
Measured: 6 Weeks
Optical Coherence Tomography (OCT)
Measurement of cutaneous morphology of seborrheic dermatitis
Measured: 6 Weeks
Liquid chromatography-mass spectrometry (LC-MS)
Will evaluate the changes in lipid composition of stratum corneum (SC).
Measured: 6 Weeks
Secondary outcomes (13)
Skin microbiota
collection of skin culture sample to evaluate skin microbiota
Measured: 6 Weeks
Skin mycobiota
collection of skin culture sample to evaluate skin mycobiota
Measured: 6 Weeks
Faecal microbiome
collection of faecal samples to evaluate faecal microbiome
Measured: 4 Weeks
Adverse events collected throughout the study
Measured: 6 Weeks
Vital signs performed at screening and end of study
Evaluation of systolic and diastolic blood pressure
Measured: 6 Weeks
Vital signs performed at screening and end of study
Evaluation of pulse rate
Measured: 6 Weeks
Vital signs performed at screening and end of study
Evaluation of temperature
Measured: 6 Weeks
12-Lead ECGs performed at screening and end of study
Assessment of heart rate
Measured: 6 Weeks
12-Lead ECGs performed at screening and end of study
Assessment of PR, QRS, QT, QTcB and QTcF
Measured: 6 Weeks
Haematology blood sample assessment
Evaluation of blood collected in BD Vacutainer K2EDTA tube.
Measured: 6 Weeks
Chemistry blood sample assessment
Evaluation of blood collected in BD Vacutainer SST Gel and Clot Activator tube.
Measured: 6 Weeks
Urinalysis urine sample assessment
Evaluation of urine specimen by dipstick
Measured: 6 Weeks
Collection of concomitant medications
questionnaire at each visit to collect concomitant medications taken
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start22 Oct 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maruho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Rissmann, PhD, Principal investigator, Centre for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688971
- Sponsor's protocol ID
- CLS001-CO-PR-017
- Status last verified
- Apr 2019
- First submitted
- 25 Sep 2018
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03688971
- Acronym / sponsor ID
- CLS001-CO-PR-017
- Conditions
- Seborrheic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omiganan Topical Gel | Experimental | Drug: OmigananOmiganan 1.75% |
| Ketoconazole Topical Cream | Active comparator | Drug: KetoconazoleKetoconazole 2.0% |
| Vehicle | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmigananOmiganan Topical Gel | Drug | Omiganan Topical Gel |
| KetoconazoleKetoconazole Cream | Drug | Ketoconazole Topical Cream |
| PlaceboVehicle | Drug | Vehicle |
Primary outcome
Seborrheic dermatitis area severity index (SDASI)
Time frame: 6 Weeks
Assessment of erythema, scales and papules and each are scored as 0=none to 3=severe.
Investigator global assessment (IGA)
Time frame: 6 Weeks
This is a 5-point scale ranging from 0=clear to 4=severe.
Area of involvement
Time frame: 6 Weeks
Facial area involvement is estimated as a % of the body surface area (BSA)
Patient Reported Outcome (PRO) - eDiary
Time frame: 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
Time frame: 6 Weeks
Multidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution.
PRO - dermatology life quality index (DLQI)
Time frame: 6 Weeks
Asses health-related quality of life in general dermatology disability index
Standardized photography
Time frame: 6 Weeks
Facial photographs will be taken by a 2D camera (VISIA-CR)
Sebum measurements
Time frame: 6 Weeks
Measurement of sebum excretion by Sebumeter
Trans Epidermal Water Loss (TEWL)
Time frame: 6 Weeks
To assess barrier status of lesional and non-lesional skin.
Optical Coherence Tomography (OCT)
Time frame: 6 Weeks
Measurement of cutaneous morphology of seborrheic dermatitis
Liquid chromatography-mass spectrometry (LC-MS)
Time frame: 6 Weeks
Will evaluate the changes in lipid composition of stratum corneum (SC).
13 secondary outcomes
Skin microbiota
Time frame: 6 Weeks
Skin mycobiota
Time frame: 6 Weeks
Faecal microbiome
Time frame: 4 Weeks
Adverse events collected throughout the study
Time frame: 6 Weeks
Vital signs performed at screening and end of study
Time frame: 6 Weeks
Vital signs performed at screening and end of study
Time frame: 6 Weeks
Vital signs performed at screening and end of study
Time frame: 6 Weeks
12-Lead ECGs performed at screening and end of study
Time frame: 6 Weeks
12-Lead ECGs performed at screening and end of study
Time frame: 6 Weeks
Haematology blood sample assessment
Time frame: 6 Weeks
Chemistry blood sample assessment
Time frame: 6 Weeks
Urinalysis urine sample assessment
Time frame: 6 Weeks
Collection of concomitant medications
Time frame: 6 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Rissmann, PhD principal investigator
Centre for Human Drug Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omiganan and Ketoconazole in people with Seborrheic Dermatitis, run by Maruho Co., Ltd. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Rissmann, PhD (+ 31 (0) 71 5246 400, clintrials@chdr.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seborrheic dermatitis area severity index (SDASI) (time frame: 6 Weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.