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

Seborrheic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656368
• Other study ID #: KAM-SEB_FC-01
• Status: Completed
• Phase: N/A
• First received: January 6, 2016
• Last updated: January 13, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Kamedis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: CEIC Puerta hierro
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Eczema
• Seborrheic Dermatitis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kamedis Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of overall ISGA. Descriptive Name of scale. Physician dermatology evaluation.		Days 42	Yes
Secondary	Improvement of erythema, desquamation on the target area. Physiological parameter. Physician dermatology evaluation.		Days 0, 14, 28 and 42	Yes
Secondary	Improvement of pruritus. Physiological parameter. Assessed by subject.		Days 0, 14, 28 and 42	Yes
Secondary	Number and severity of Adverse Events		Days 0, 14, 28 and 42	Yes