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

NCT03688971 | Unknown Phase 2

• 1 other identifier: CLS001-CO-PR-017
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Seborrheic Dermatitis

Outcome Measures

Primary Outcomes (11)

• Seborrheic dermatitis area severity index (SDASI)

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

  6 Weeks

• Investigator global assessment (IGA)

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

  6 Weeks

• Area of involvement

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

  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.

  4 Weeks

• PRO - 5-D itch scale

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

  6 Weeks

• PRO - dermatology life quality index (DLQI)

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

  6 Weeks

• Standardized photography

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

  6 Weeks

• Sebum measurements

  Measurement of sebum excretion by Sebumeter

  6 Weeks

• Trans Epidermal Water Loss (TEWL)

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

  6 Weeks

• Optical Coherence Tomography (OCT)

  Measurement of cutaneous morphology of seborrheic dermatitis

  6 Weeks

• Liquid chromatography-mass spectrometry (LC-MS)

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

  6 Weeks

Secondary Outcomes (13)

• Skin microbiota

  6 Weeks

• Skin mycobiota

  6 Weeks

• Faecal microbiome

  4 Weeks

• Adverse events collected throughout the study

  6 Weeks

• Vital signs performed at screening and end of study

  6 Weeks

Study Arms (3)

Omiganan Topical Gel

EXPERIMENTAL

Omiganan 1.75%

Drug: Omiganan

Ketoconazole Topical Cream

ACTIVE COMPARATOR

Ketoconazole 2.0%

Drug: Ketoconazole

Vehicle

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Omiganan DRUG

Omiganan Topical Gel

Omiganan Topical Gel

Ketoconazole DRUG

Ketoconazole Cream

Ketoconazole Topical Cream

Placebo DRUG

Vehicle

Vehicle

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Maruho Co., Ltd.: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, Netherlands

RECRUITING

MeSH Terms

Conditions

Dermatitis, Seborrheic

Interventions

Omiganan; Ketoconazole

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Robert Rissmann, PhD

  Centre for Human Drug Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Rissmann, PhD

CONTACT

+ 31 (0) 71 5246 400; clintrials@chdr.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 28, 2018
• Study Start: October 22, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

NL (1)