Phase
Condition
Seborrheic Dermatitis
Seborrhea
Eczema (Atopic Dermatitis - Pediatric)
Treatment
N/AClinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female subjects with mild to moderate facial SD (IGA 2 or 3), ≥18 years ofage, inclusive. The health status is verified by absence of evidence of any clinicalsignificant active or uncontrolled chronic disease other than SD following a detailedmedical 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 medicallyqualified designee
Able to participate and willing to give written informed consent and to comply withthe study restrictions;
Willing to refrain from using other SD treatments in the local treatment area
Subjects and their partners of childbearing potential must use effectivecontraception, for the duration of the study and for 3 months after the last dose.
Exclusion
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 asfollows;
Topical steroids, antibiotics, antifungals or other topical (OTC) therapies: 2weeks
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 OTCzinc pyrithione shampoo), soap for the treatment of seborrheic dermatitis: 2weeks
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 ofenrollment;
Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
Participation in an investigational drug or device study within 3 months prior toscreening 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.
Study Design
Connect with a study center
Centre for Human Drug Research
Leiden,
NetherlandsActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.