Clinical trial NCT02656368: Safety and Efficacy of SEBORRHEAMEDIS Face Cream in Patients With Seborrheic Dermatitis
Official title: Safety and Efficacy of SEBORRHEAMEDIS Face Cream in Patients With Seborrheic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seborrheic Dermatitis
Lead sponsor: Kamedis Ltd.
Sponsor class: INDUSTRY
First posted: 2016-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Subject with mild (ISGA=2) to moderate (ISGA=3) facial Seborrheic dermatitis.
* Male or female aged 18 years or older.
* Subject who agrees not to use any Seborrheic Dermatitis medication during the study, except for the tested product.
* Subject is willing to sign an Informed Consent

Exclusion Criteria:

* Subject pregnant or lactating.
* Subject has a condition that requires continuous systemic or topical corticosteroid or antimycotic therapy
* Subject has a severe disease that is likely to interfere with the study conducting
* Subject has a known sensitivity to any of the ingredients contained in the tested product.
* Subject is expected to be extensively exposed to the sun during the study

Primary outcomes:
measure: Improvement of overall ISGA. Descriptive Name of scale. Physician dermatology evaluation.
timeFrame: Days 42
Secondary outcomes:
measure: Improvement of erythema, desquamation on the target area. Physiological parameter. Physician dermatology evaluation.
timeFrame: Days 0, 14, 28 and 42
measure: Improvement of pruritus. Physiological parameter. Assessed by subject.
timeFrame: Days 0, 14, 28 and 42
measure: Number and severity of Adverse Events
timeFrame: Days 0, 14, 28 and 42
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de l'Esperit Sant
name: Rubén del Rio Gil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barak-Shinar D, Del Rio R, Green LJ. Treatment of Seborrheic Dermatitis Using a Novel Herbal-based Cream. J Clin Aesthet Dermatol. 2017 Apr;10(4):17-23.