To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Centre for Human Drug Research
Leiden, Netherlands
RECRUITINGSeborrheic dermatitis area severity index (SDASI)
Assessment of erythema, scales and papules and each are scored as 0=none to 3=severe.
Time frame: 6 Weeks
Investigator global assessment (IGA)
This is a 5-point scale ranging from 0=clear to 4=severe.
Time frame: 6 Weeks
Area of involvement
Facial area involvement is estimated as a % of the body surface area (BSA)
Time frame: 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.
Time frame: 4 Weeks
PRO - 5-D itch scale
Multidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution.
Time frame: 6 Weeks
PRO - dermatology life quality index (DLQI)
Asses health-related quality of life in general dermatology disability index
Time frame: 6 Weeks
Standardized photography
Facial photographs will be taken by a 2D camera (VISIA-CR)
Time frame: 6 Weeks
Sebum measurements
Measurement of sebum excretion by Sebumeter
Time frame: 6 Weeks
Trans Epidermal Water Loss (TEWL)
To assess barrier status of lesional and non-lesional skin.
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Time frame: 6 Weeks
Optical Coherence Tomography (OCT)
Measurement of cutaneous morphology of seborrheic dermatitis
Time frame: 6 Weeks
Liquid chromatography-mass spectrometry (LC-MS)
Will evaluate the changes in lipid composition of stratum corneum (SC).
Time frame: 6 Weeks
Skin microbiota
collection of skin culture sample to evaluate skin microbiota
Time frame: 6 Weeks
Skin mycobiota
collection of skin culture sample to evaluate skin mycobiota
Time frame: 6 Weeks
Faecal microbiome
collection of faecal samples to evaluate faecal microbiome
Time frame: 4 Weeks
Adverse events collected throughout the study
Time frame: 6 Weeks
Vital signs performed at screening and end of study
Evaluation of systolic and diastolic blood pressure
Time frame: 6 Weeks
Vital signs performed at screening and end of study
Evaluation of pulse rate
Time frame: 6 Weeks
Vital signs performed at screening and end of study
Evaluation of temperature
Time frame: 6 Weeks
12-Lead ECGs performed at screening and end of study
Assessment of heart rate
Time frame: 6 Weeks
12-Lead ECGs performed at screening and end of study
Assessment of PR, QRS, QT, QTcB and QTcF
Time frame: 6 Weeks
Haematology blood sample assessment
Evaluation of blood collected in BD Vacutainer K2EDTA tube.
Time frame: 6 Weeks
Chemistry blood sample assessment
Evaluation of blood collected in BD Vacutainer SST Gel and Clot Activator tube.
Time frame: 6 Weeks
Urinalysis urine sample assessment
Evaluation of urine specimen by dipstick
Time frame: 6 Weeks
Collection of concomitant medications
questionnaire at each visit to collect concomitant medications taken
Time frame: 6 Weeks