Clinical trial NCT03688971: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Seborrheic Dermatitis
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial 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;

  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.

Primary outcomes:
measure: Seborrheic dermatitis area severity index (SDASI)
timeFrame: 6 Weeks
measure: Investigator global assessment (IGA)
timeFrame: 6 Weeks
measure: Area of involvement
timeFrame: 6 Weeks
measure: Patient Reported Outcome (PRO) - eDiary
timeFrame: 4 Weeks
measure: PRO - 5-D itch scale
timeFrame: 6 Weeks
measure: PRO - dermatology life quality index (DLQI)
timeFrame: 6 Weeks
measure: Standardized photography
timeFrame: 6 Weeks
measure: Sebum measurements
timeFrame: 6 Weeks
measure: Trans Epidermal Water Loss (TEWL)
timeFrame: 6 Weeks
measure: Optical Coherence Tomography (OCT)
timeFrame: 6 Weeks
measure: Liquid chromatography-mass spectrometry (LC-MS)
timeFrame: 6 Weeks
Secondary outcomes:
measure: Skin microbiota
timeFrame: 6 Weeks
measure: Skin mycobiota
timeFrame: 6 Weeks
measure: Faecal microbiome
timeFrame: 4 Weeks
measure: Adverse events collected throughout the study
timeFrame: 6 Weeks
measure: Vital signs performed at screening and end of study
timeFrame: 6 Weeks
measure: Vital signs performed at screening and end of study
timeFrame: 6 Weeks
measure: Vital signs performed at screening and end of study
timeFrame: 6 Weeks
measure: 12-Lead ECGs performed at screening and end of study
timeFrame: 6 Weeks
measure: 12-Lead ECGs performed at screening and end of study
timeFrame: 6 Weeks
measure: Haematology blood sample assessment
timeFrame: 6 Weeks
measure: Chemistry blood sample assessment
timeFrame: 6 Weeks
measure: Urinalysis urine sample assessment
timeFrame: 6 Weeks
measure: Collection of concomitant medications
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
affiliation: Centre for Human Drug Research
name: Robert Rissmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: