Safety and Efficacy of SEBORRHEAMEDIS Face Cream in Patients With Seborrheic Dermatitis

NCT ID: NCT02656368

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

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

Conditions

Seborrheic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional, open label, Safety/Efficacy Study

SEBORRHEAMEDIS Face Cream Interventional 30

Group Type: EXPERIMENTAL

SEBORRHEAMEDIS Face Cream

Intervention Type: DEVICE

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.

Interventions

SEBORRHEAMEDIS Face Cream

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kamedis Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rubén del Rio Gil, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de l'Esperit Sant

References

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.

Reference Type: DERIVED

PMID: 28458770 (View on PubMed)

Other Identifiers

KAM-SEB_FC-01

Identifier Type: -

Identifier Source: org_study_id