Seborrheic Dermatitis Clinical Trial
Official title:
Safety and Efficacy of SEBORRHEAMEDIS Face Cream in Patients With Seborrheic Dermatitis
SEBORRHEAMEDIS Face Cream is a barrier-based, non-steroidal cream. The cream includes plant extracts The cream was designed to manage the symptoms of facial Seborrheic dermatitis symptoms such as erythema, scaling and pruritus.
30 subjects will be enrolled to the study. After eligibility is confirmed, subjects will be
asked to sign an Informed Consent form.
At the baseline visit, the investigator will select a target area on the face. The target
area will be evaluated for erythema (redness) and desquamation (scaling) using a 5-point
scale: 0 = none, 1 = minimal, 2 = mild, 3 = moderate and 4 = severe. Photography of the
target area will be taken. For reference, a fixed object (such as a ruler) will be
photographed in the same frame. In addition, the investigator will assess the overall facial
lesions using an ISGA based on a 5-point scale. The subject will evaluate his/her pruritis
over the past 24 hours, using a 5-point scale: 0 = no itching, 1 = minimal and rare itching,
2= mild itching, (subject is aware of the itching only when relaxed), 3= moderate itching
(subject is often aware of the itching, which occasionally disturbs sleep), 4 = severe and
constant itching.
Subjects will be instructed to use SEBORRHEAMEDIS Face Cream twice a day, morning and
evening, for a consecutive period of 42 days. In addition to the baseline visit (day 0),
subjects will be asked to come to the clinic for two follow-up visits at days 14 and 28 and
for a final visit at day 42. A flexibility of ±2 days will be allowed. In case of an adverse
event, the subject will be asked to immediately contact the clinic, and to come to an
unscheduled visit if needed.
At each of the two follow-up visits and at the final visit, the investigator will evaluate
the overall severity of seborrhea (ISGA) and the target area's erythema and desquamation.
The subject will assess his/her pruritus over the past 24 hours.
At the final visit, the subject will also complete a product-assessment questionnaire. The
questionnaire will ask several questions about satisfaction attributes, using a 5-point
scale: -2 = very unsatisfied, -1 = unsatisfied, 0 = neutral, +1 = satisfied, +2 = very
satisfied. Attributes will include: overall satisfaction, speed of results, ease of use,
ease of spread, comfort under makeup, feel on the skin (-2 = very greasy, +2 = very
moisturizing), speed of absorption, texture, color and odor
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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