Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis
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|ClinicalTrials.gov Identifier: NCT03688971|
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : May 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Seborrheic Dermatitis||Drug: Omiganan Drug: Ketoconazole Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||October 22, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Omiganan Topical Gel
Omiganan Topical Gel
Active Comparator: Ketoconazole Topical Cream
|Placebo Comparator: Vehicle||
- Seborrheic dermatitis area severity index (SDASI) [ Time Frame: 6 Weeks ]Assessment of erythema, scales and papules and each are scored as 0=none to 3=severe.
- Investigator global assessment (IGA) [ Time Frame: 6 Weeks ]This is a 5-point scale ranging from 0=clear to 4=severe.
- Area of involvement [ Time Frame: 6 Weeks ]Facial area involvement is estimated as a % of the body surface area (BSA)
- Patient Reported Outcome (PRO) - eDiary [ Time Frame: 4 Weeks ]Single-question assessment regarding patient's worst itch. On a scale of 0-100, 0=no itch and 100=worst itch.
- PRO - 5-D itch scale [ Time Frame: 6 Weeks ]Multidimensional measure of itching. Covers 5 domains: duration, degree, direction, disability and distribution.
- PRO - dermatology life quality index (DLQI) [ Time Frame: 6 Weeks ]Asses health-related quality of life in general dermatology disability index
- Standardized photography [ Time Frame: 6 Weeks ]Facial photographs will be taken by a 2D camera (VISIA-CR)
- Sebum measurements [ Time Frame: 6 Weeks ]Measurement of sebum excretion by Sebumeter
- Trans Epidermal Water Loss (TEWL) [ Time Frame: 6 Weeks ]To assess barrier status of lesional and non-lesional skin.
- Optical Coherence Tomography (OCT) [ Time Frame: 6 Weeks ]Measurement of cutaneous morphology of seborrheic dermatitis
- Liquid chromatography-mass spectrometry (LC-MS) [ Time Frame: 6 Weeks ]Will evaluate the changes in lipid composition of stratum corneum (SC).
- Skin microbiota [ Time Frame: 6 Weeks ]collection of skin culture sample to evaluate skin microbiota
- Skin mycobiota [ Time Frame: 6 Weeks ]collection of skin culture sample to evaluate skin mycobiota
- Faecal microbiome [ Time Frame: 4 Weeks ]collection of faecal samples to evaluate faecal microbiome
- Adverse events collected throughout the study [ Time Frame: 6 Weeks ]
- Vital signs performed at screening and end of study [ Time Frame: 6 Weeks ]Evaluation of systolic and diastolic blood pressure
- Vital signs performed at screening and end of study [ Time Frame: 6 Weeks ]Evaluation of pulse rate
- Vital signs performed at screening and end of study [ Time Frame: 6 Weeks ]Evaluation of temperature
- 12-Lead ECGs performed at screening and end of study [ Time Frame: 6 Weeks ]Assessment of heart rate
- 12-Lead ECGs performed at screening and end of study [ Time Frame: 6 Weeks ]Assessment of PR, QRS, QT, QTcB and QTcF
- Haematology blood sample assessment [ Time Frame: 6 Weeks ]Evaluation of blood collected in BD Vacutainer K2EDTA tube.
- Chemistry blood sample assessment [ Time Frame: 6 Weeks ]Evaluation of blood collected in BD Vacutainer SST Gel and Clot Activator tube.
- Urinalysis urine sample assessment [ Time Frame: 6 Weeks ]Evaluation of urine specimen by dipstick
- Collection of concomitant medications [ Time Frame: 6 Weeks ]questionnaire at each visit to collect concomitant medications taken
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688971
|Contact: Robert Rissmann, PhD||+ 31 (0) 71 5246 firstname.lastname@example.org|
|Centre for Human Drug Research||Recruiting|
|Contact: Robert Rissmann, PhD + 31(0) 71 5246 400 email@example.com|
|Principal Investigator: Robert Rissmann, PhD|
|Principal Investigator:||Robert Rissmann, PhD||Centre for Human Drug Research|