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Status unknownNCT03688971Updated May 1, 2019

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

A Phase 2 interventional study of Omiganan and Ketoconazole in Seborrheic Dermatitis, sponsored by Maruho Co., Ltd.. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-05-01.

Sponsored by Maruho Co., Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Seborrheic Dermatitis
03

In context

Dermatitis

1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.

This study's planned enrollment of 36 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

Maruho Co., Ltd. is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Omiganan Topical Gel

    Omiganan 1.75%

    Drug: Omiganan

  • Active comparator
    Ketoconazole Topical Cream

    Ketoconazole 2.0%

    Drug: Ketoconazole

  • Placebo comparator
    Vehicle

    Drug: Placebo

Interventions

  • DrugOmiganan

    Omiganan Topical Gel

  • DrugKetoconazole

    Ketoconazole Cream

  • DrugPlacebo

    Vehicle

06

What researchers measure

Primary outcomes

  1. Seborrheic dermatitis area severity index (SDASI)

    Assessment of erythema, scales and papules and each are scored as 0=none to 3=severe.

    Time frame: 6 Weeks

  2. Investigator global assessment (IGA)

    This is a 5-point scale ranging from 0=clear to 4=severe.

    Time frame: 6 Weeks

  3. Area of involvement

    Facial area involvement is estimated as a % of the body surface area (BSA)

    Time frame: 6 Weeks

  4. 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.

    Time frame: 4 Weeks

  5. PRO - 5-D itch scale

    Multidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution.

    Time frame: 6 Weeks

  6. PRO - dermatology life quality index (DLQI)

    Asses health-related quality of life in general dermatology disability index

    Time frame: 6 Weeks

  7. Standardized photography

    Facial photographs will be taken by a 2D camera (VISIA-CR)

    Time frame: 6 Weeks

  8. Sebum measurements

    Measurement of sebum excretion by Sebumeter

    Time frame: 6 Weeks

  9. Trans Epidermal Water Loss (TEWL)

    To assess barrier status of lesional and non-lesional skin.

    Time frame: 6 Weeks

  10. Optical Coherence Tomography (OCT)

    Measurement of cutaneous morphology of seborrheic dermatitis

    Time frame: 6 Weeks

  11. Liquid chromatography-mass spectrometry (LC-MS)

    Will evaluate the changes in lipid composition of stratum corneum (SC).

    Time frame: 6 Weeks

Secondary outcomes

  1. Skin microbiota

    collection of skin culture sample to evaluate skin microbiota

    Time frame: 6 Weeks

  2. Skin mycobiota

    collection of skin culture sample to evaluate skin mycobiota

    Time frame: 6 Weeks

  3. Faecal microbiome

    collection of faecal samples to evaluate faecal microbiome

    Time frame: 4 Weeks

  4. Adverse events collected throughout the study

    Time frame: 6 Weeks

  5. Vital signs performed at screening and end of study

    Evaluation of systolic and diastolic blood pressure

    Time frame: 6 Weeks

  6. Vital signs performed at screening and end of study

    Evaluation of pulse rate

    Time frame: 6 Weeks

  7. Vital signs performed at screening and end of study

    Evaluation of temperature

    Time frame: 6 Weeks

  8. 12-Lead ECGs performed at screening and end of study

    Assessment of heart rate

    Time frame: 6 Weeks

  9. 12-Lead ECGs performed at screening and end of study

    Assessment of PR, QRS, QT, QTcB and QTcF

    Time frame: 6 Weeks

  10. Haematology blood sample assessment

    Evaluation of blood collected in BD Vacutainer K2EDTA tube.

    Time frame: 6 Weeks

  11. Chemistry blood sample assessment

    Evaluation of blood collected in BD Vacutainer SST Gel and Clot Activator tube.

    Time frame: 6 Weeks

  12. Urinalysis urine sample assessment

    Evaluation of urine specimen by dipstick

    Time frame: 6 Weeks

  13. Collection of concomitant medications

    questionnaire at each visit to collect concomitant medications taken

    Time frame: 6 Weeks

07

Study locations

1 of 1 sites recruiting
  • Centre for Human Drug Research
    Leiden, Netherlands
    • Robert Rissmann, PhD · Contact · clintrial@chdr.nl · + 31(0) 71 5246 400
    • Robert Rissmann, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03688971
Lead sponsor
Maruho Co., Ltd.
Responsible party
Sponsor
First posted
Sep 28, 2018
Start date
Oct 22, 2018
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
May 1, 2019

Study contacts

Robert Rissmann, PhD
Contact
clintrials@chdr.nl
+ 31 (0) 71 5246 400
Robert Rissmann, PhD
principal investigator · Centre for Human Drug Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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