seborrheic dermatitis
Conditions
Interventions
CLS001 is a topical gel containing omiganan, a 12-amino-acid cationic peptide.
A previous phase 2 drug study in atopic dermatitis patients studied dosage of 1
and 2.5 % QD with a maximum treated bod
Sponsors
Maruho Co., Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For enrollment of subjects the following criteria must be met: 1. 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; 2. Confirmed SD diagnosis by dermatologist 3. Significant facial SD affected area as judged by the investigator or medically qualified designee. 4. Able to participate and willing to give written informed consent and to comply with the study restrictions; 5. Willing to refrain from using other SD treatments in the local treatment area 6. 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
Exclusion criteria: Eligible subjects must meet none of the following exclusion criteria: 1. Any current and / or recurrent clinical significant skin condition other than SD; 2. Ongoing use of prohibited SD medication. Washout periods prior to baseline are as follows; a. Topical steroids, antibiotics, antifungals or other (OTC) topical therapies: 2 weeks b. Systemic steroids, antibiotics, antifungals or other systemic therapies: 4 weeks; c. Phototherapy: 3 weeks; d. 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 e. Changing a soap, method for daily facial and hair washing: 1 week 3. Known hypersensitivity to the compounds or excipients of the compounds; 4. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment; 5. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding; 6. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year; 7. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic endpoints * Microbiome (for skin: microbiota and mycobiota, for gut: microbiota) * Mycology (mycobiome and culture) * Sebum measurement (Sebumeter) * Skin barrier function by Trans Epidermal Water Loss (TEWL) * Skin morphology by Optical coherence tomography (OCT) * Changes in stratum corneum lipid composition by liquid chromatography-mass spectrometry (LC-MS) Efficacy endpoints * Seborrheic dermatitis area severity index (SDASI) * Investigator Global Assessment (IGA) * Area of involvement (% body surface area affected by facial SD) * Patient reported outcomes (5D- itch scale, daily NRS itch, DLQI) * Standardized facial photography by VISIA-CR Tolerability / safety endpoints Adverse events (AE) will be collected throughout the study, at every study visit. Laboratory safety testing, 12-Lead ECGs and vital signs will be performed at screening and at end of study (EOS). | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
Netherlands
Outcome results
None listed