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

Phase 2

• Conditions: Seborrheic Dermatitis
• Interventions: Drug: Omiganan; Drug: Placebo; Drug: Ketoconazole

• Registration Number: NCT03688971
• Lead Sponsor: Maruho Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-28
• Study Start: 2018-10-22
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omiganan Topical Gel	Omiganan	Omiganan 1.75%
Vehicle	Placebo	-
Ketoconazole Topical Cream	Ketoconazole	Ketoconazole 2.0%

Primary Outcome Measures

Name	Time	Method
PRO - 5-D itch scale	6 Weeks	Multidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution.
Sebum measurements	6 Weeks	Measurement of sebum excretion by Sebumeter
Seborrheic dermatitis area severity index (SDASI)	6 Weeks	Assessment of erythema, scales and papules and each are scored as 0=none to 3=severe.
PRO - dermatology life quality index (DLQI)	6 Weeks	Asses health-related quality of life in general dermatology disability index
Investigator global assessment (IGA)	6 Weeks	This is a 5-point scale ranging from 0=clear to 4=severe.
Area of involvement	6 Weeks	Facial area involvement is estimated as a % of the body surface area (BSA)
Liquid chromatography-mass spectrometry (LC-MS)	6 Weeks	Will evaluate the changes in lipid composition of stratum corneum (SC).
Patient Reported Outcome (PRO) - eDiary	4 Weeks	Single-question assessment regarding patient's worst itch. On a scale of 0-100, 0=no itch and 100=worst itch.
Standardized photography	6 Weeks	Facial photographs will be taken by a 2D camera (VISIA-CR)
Trans Epidermal Water Loss (TEWL)	6 Weeks	To assess barrier status of lesional and non-lesional skin.
Optical Coherence Tomography (OCT)	6 Weeks	Measurement of cutaneous morphology of seborrheic dermatitis

Secondary Outcome Measures

Name	Time	Method
Chemistry blood sample assessment	6 Weeks	Evaluation of blood collected in BD Vacutainer SST Gel and Clot Activator tube.
Skin microbiota	6 Weeks	collection of skin culture sample to evaluate skin microbiota
12-Lead ECGs performed at screening and end of study	6 Weeks	Assessment of PR, QRS, QT, QTcB and QTcF
Haematology blood sample assessment	6 Weeks	Evaluation of blood collected in BD Vacutainer K2EDTA tube.
Skin mycobiota	6 Weeks	collection of skin culture sample to evaluate skin mycobiota
Faecal microbiome	4 Weeks	collection of faecal samples to evaluate faecal microbiome
Adverse events collected throughout the study	6 Weeks
Urinalysis urine sample assessment	6 Weeks	Evaluation of urine specimen by dipstick
Collection of concomitant medications	6 Weeks	questionnaire at each visit to collect concomitant medications taken
Vital signs performed at screening and end of study	6 Weeks	Evaluation of temperature

Trial Locations

Locations (1)

Centre for Human Drug Research; 🇳🇱 Leiden, Netherlands