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

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ClinicalTrials.gov Identifier: NCT03688971
Recruitment Status : Unknown
Verified April 2019 by Maruho Co., Ltd..
Recruitment status was:  Recruiting
First Posted : September 28, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Seborrheic Dermatitis Drug: Omiganan Drug: Ketoconazole Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.

  2. Investigator global assessment (IGA) [ Time Frame: 6 Weeks ]
    This is a 5-point scale ranging from 0=clear to 4=severe.

  3. Area of involvement [ Time Frame: 6 Weeks ]
    Facial area involvement is estimated as a % of the body surface area (BSA)

  4. 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.

  5. PRO - 5-D itch scale [ Time Frame: 6 Weeks ]
    Multidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution.

  6. PRO - dermatology life quality index (DLQI) [ Time Frame: 6 Weeks ]
    Asses health-related quality of life in general dermatology disability index

  7. Standardized photography [ Time Frame: 6 Weeks ]
    Facial photographs will be taken by a 2D camera (VISIA-CR)

  8. Sebum measurements [ Time Frame: 6 Weeks ]
    Measurement of sebum excretion by Sebumeter

  9. Trans Epidermal Water Loss (TEWL) [ Time Frame: 6 Weeks ]
    To assess barrier status of lesional and non-lesional skin.

  10. Optical Coherence Tomography (OCT) [ Time Frame: 6 Weeks ]
    Measurement of cutaneous morphology of seborrheic dermatitis

  11. Liquid chromatography-mass spectrometry (LC-MS) [ Time Frame: 6 Weeks ]
    Will evaluate the changes in lipid composition of stratum corneum (SC).


Secondary Outcome Measures :
  1. Skin microbiota [ Time Frame: 6 Weeks ]
    collection of skin culture sample to evaluate skin microbiota

  2. Skin mycobiota [ Time Frame: 6 Weeks ]
    collection of skin culture sample to evaluate skin mycobiota

  3. Faecal microbiome [ Time Frame: 4 Weeks ]
    collection of faecal samples to evaluate faecal microbiome

  4. Adverse events collected throughout the study [ Time Frame: 6 Weeks ]
  5. Vital signs performed at screening and end of study [ Time Frame: 6 Weeks ]
    Evaluation of systolic and diastolic blood pressure

  6. Vital signs performed at screening and end of study [ Time Frame: 6 Weeks ]
    Evaluation of pulse rate

  7. Vital signs performed at screening and end of study [ Time Frame: 6 Weeks ]
    Evaluation of temperature

  8. 12-Lead ECGs performed at screening and end of study [ Time Frame: 6 Weeks ]
    Assessment of heart rate

  9. 12-Lead ECGs performed at screening and end of study [ Time Frame: 6 Weeks ]
    Assessment of PR, QRS, QT, QTcB and QTcF

  10. Haematology blood sample assessment [ Time Frame: 6 Weeks ]
    Evaluation of blood collected in BD Vacutainer K2EDTA tube.

  11. Chemistry blood sample assessment [ Time Frame: 6 Weeks ]
    Evaluation of blood collected in BD Vacutainer SST Gel and Clot Activator tube.

  12. Urinalysis urine sample assessment [ Time Frame: 6 Weeks ]
    Evaluation of urine specimen by dipstick

  13. Collection of concomitant medications [ Time Frame: 6 Weeks ]
    questionnaire at each visit to collect concomitant medications taken


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

    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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688971


Contacts
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Contact: Robert Rissmann, PhD + 31 (0) 71 5246 400 clintrials@chdr.nl

Locations
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Netherlands
Centre for Human Drug Research Recruiting
Leiden, Netherlands
Contact: Robert Rissmann, PhD    + 31(0) 71 5246 400    clintrial@chdr.nl   
Principal Investigator: Robert Rissmann, PhD         
Sponsors and Collaborators
Maruho Co., Ltd.
Investigators
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Principal Investigator: Robert Rissmann, PhD Centre for Human Drug Research
More Information
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Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT03688971    
Other Study ID Numbers: CLS001-CO-PR-017
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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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
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Ketoconazole
Antifungal Agents
Anti-Infective Agents
 14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors