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

Seborrheic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03688971
• Other study ID #: CLS001-CO-PR-017
• Status: Recruiting
• Phase: Phase 2
• Start date: October 22, 2018
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Cutanea Life Sciences, Inc.
• Contact: Robert Rissmann, PhD
• Phone: + 31 (0) 71 5246 400
• Email: clintrials[@]chdr.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Seborrheic Dermatitis

Intervention

Drug:
• Omiganan
Omiganan Topical Gel
• Ketoconazole
Ketoconazole Cream
• Placebo
Vehicle

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Cutanea Life Sciences, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seborrheic dermatitis area severity index (SDASI)	Assessment of erythema, scales and papules and each are scored as 0=none to 3=severe.	6 Weeks
Primary	Investigator global assessment (IGA)	This is a 5-point scale ranging from 0=clear to 4=severe.	6 Weeks
Primary	Area of involvement	Facial area involvement is estimated as a % of the body surface area (BSA)	6 Weeks
Primary	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
Primary	PRO - 5-D itch scale	Multidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution.	6 Weeks
Primary	PRO - dermatology life quality index (DLQI)	Asses health-related quality of life in general dermatology disability index	6 Weeks
Primary	Standardized photography	Facial photographs will be taken by a 2D camera (VISIA-CR)	6 Weeks
Primary	Sebum measurements	Measurement of sebum excretion by Sebumeter	6 Weeks
Primary	Trans Epidermal Water Loss (TEWL)	To assess barrier status of lesional and non-lesional skin.	6 Weeks
Primary	Optical Coherence Tomography (OCT)	Measurement of cutaneous morphology of seborrheic dermatitis	6 Weeks
Primary	Liquid chromatography-mass spectrometry (LC-MS)	Will evaluate the changes in lipid composition of stratum corneum (SC).	6 Weeks
Secondary	Skin microbiota	collection of skin culture sample to evaluate skin microbiota	6 Weeks
Secondary	Skin mycobiota	collection of skin culture sample to evaluate skin mycobiota	6 Weeks
Secondary	Faecal microbiome	collection of faecal samples to evaluate faecal microbiome	4 Weeks
Secondary	Adverse events collected throughout the study		6 Weeks
Secondary	Vital signs performed at screening and end of study	Evaluation of systolic and diastolic blood pressure	6 Weeks
Secondary	Vital signs performed at screening and end of study	Evaluation of pulse rate	6 Weeks
Secondary	Vital signs performed at screening and end of study	Evaluation of temperature	6 Weeks
Secondary	12-Lead ECGs performed at screening and end of study	Assessment of heart rate	6 Weeks
Secondary	12-Lead ECGs performed at screening and end of study	Assessment of PR, QRS, QT, QTcB and QTcF	6 Weeks
Secondary	Haematology blood sample assessment	Evaluation of blood collected in BD Vacutainer K2EDTA tube.	6 Weeks
Secondary	Chemistry blood sample assessment	Evaluation of blood collected in BD Vacutainer SST Gel and Clot Activator tube.	6 Weeks
Secondary	Urinalysis urine sample assessment	Evaluation of urine specimen by dipstick	6 Weeks
Secondary	Collection of concomitant medications	questionnaire at each visit to collect concomitant medications taken	6 Weeks