Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-11 @ 2:27 PM
Study NCT ID:
NCT02656368
Status:
COMPLETED
Last Update Posted:
2016-01-14
First Post:
2016-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of SEBORRHEAMEDIS Face Cream in Patients With Seborrheic Dermatitis
Sponsor:
Kamedis Ltd.
Organization:
Study Overview
Official Title:
Safety and Efficacy of SEBORRHEAMEDIS Face Cream in Patients With Seborrheic Dermatitis
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: