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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02656368
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Kamedis Ltd.

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.

Condition or disease Intervention/treatment Phase
Seborrheic Dermatitis Device: SEBORRHEAMEDIS Face Cream Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of SEBORRHEAMEDIS Face Cream in Patients With Seborrheic Dermatitis
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional, open label, Safety/Efficacy Study
SEBORRHEAMEDIS Face Cream Interventional 30
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.




Primary Outcome Measures :
  1. Improvement of overall ISGA. Descriptive Name of scale. Physician dermatology evaluation. [ Time Frame: Days 42 ]

Secondary Outcome Measures :
  1. Improvement of erythema, desquamation on the target area. Physiological parameter. Physician dermatology evaluation. [ Time Frame: Days 0, 14, 28 and 42 ]
  2. Improvement of pruritus. Physiological parameter. Assessed by subject. [ Time Frame: Days 0, 14, 28 and 42 ]
  3. Number and severity of Adverse Events [ Time Frame: Days 0, 14, 28 and 42 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656368


Sponsors and Collaborators
Kamedis Ltd.
Investigators
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Principal Investigator: Rubén del Rio Gil, MD HOSPITAL DE L'ESPERIT SANT

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kamedis Ltd.
ClinicalTrials.gov Identifier: NCT02656368     History of Changes
Other Study ID Numbers: KAM-SEB_FC-01
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: March 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous