Safety and Efficacy of SEBORRHEAMEDIS Face Cream in Patients With Seborrheic Dermatitis
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 6, 2016
CompletedFirst Posted
Study publicly available on registry
January 14, 2016
CompletedJanuary 14, 2016
March 1, 2015
11 months
January 6, 2016
January 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement of overall ISGA. Descriptive Name of scale. Physician dermatology evaluation.
Days 42
Secondary Outcomes (3)
Improvement of erythema, desquamation on the target area. Physiological parameter. Physician dermatology evaluation.
Days 0, 14, 28 and 42
Improvement of pruritus. Physiological parameter. Assessed by subject.
Days 0, 14, 28 and 42
Number and severity of Adverse Events
Days 0, 14, 28 and 42
Study Arms (1)
Interventional, open label, Safety/Efficacy Study
EXPERIMENTALSEBORRHEAMEDIS Face Cream Interventional 30
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kamedis Ltd.lead
Related Publications (1)
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.
PMID: 28458770DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rubén del Rio Gil, MD
Hospital de l'Esperit Sant
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2016
First Posted
January 14, 2016
Study Start
January 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 14, 2016
Record last verified: 2015-03
Data Sharing
- IPD Sharing
- Will not share