Clinical Trial: Safety and Efficacy of SEBORRHEAMEDIS Face Cream in Patients With Seborrheic Dermatitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Efficacy of SEBORRHEAMEDIS Face Cream in Patients With Seborrheic Dermatitis
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 Summary:
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-assessmen
Sponsor: Kamedis Ltd.
Current Primary Outcome: Improvement of overall ISGA. Descriptive Name of scale. Physician dermatology evaluation. [ Time Frame: Days 42 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Improvement of erythema, desquamation on the target area. Physiological parameter. Physician dermatology evaluation. [ Time Frame: Days 0, 14, 28 and 42 ]
- Improvement of pruritus. Physiological parameter. Assessed by subject. [ Time Frame: Days 0, 14, 28 and 42 ]
- Number and severity of Adverse Events [ Time Frame: Days 0, 14, 28 and 42 ]
Original Secondary Outcome: Same as current
Information By: Kamedis Ltd.
Dates:
Date Received: January 6, 2016
Date Started: January 2015
Date Completion:
Last Updated: January 13, 2016
Last Verified: March 2015
