Seborrheic DermatitisNCT02656368
Safety and Efficacy of SEBORRHEAMEDIS Face Cream in Patients With Seborrheic Dermatitis
A study testing SEBORRHEAMEDIS Face Cream in people with Seborrheic Dermatitis, run by Kamedis Ltd..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- SEBORRHEAMEDIS Face Cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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
- Being tested
- SEBORRHEAMEDIS Face Cream
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEBORRHEAMEDIS Face CreamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional, open label, Safety/Efficacy Study | Experimental | SEBORRHEAMEDIS Face Cream Interventional 30 Receives: Device: SEBORRHEAMEDIS Face Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of overall ISGA. Descriptive Name of scale. Physician dermatology evaluation.
Measured: Days 42
Secondary outcomes (3)
Improvement of erythema, desquamation on the target area. Physiological parameter. Physician dermatology evaluation.
Measured: Days 0, 14, 28 and 42
Improvement of pruritus. Physiological parameter. Assessed by subject.
Measured: Days 0, 14, 28 and 42
Number and severity of Adverse Events
Measured: Days 0, 14, 28 and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seborrheic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamedis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rubén del Rio Gil, MD, Principal investigator, Hospital de l'Esperit Sant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656368
- Sponsor's protocol ID
- KAM-SEB_FC-01
- Status last verified
- Mar 2015
- First submitted
- 6 Jan 2016
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28458770
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of SEBORRHEAMEDIS Face Cream in Patients With Seborrheic Dermatitis
- ClinicalTrials.gov ID
- NCT02656368
- Acronym / sponsor ID
- KAM-SEB_FC-01
- Conditions
- Seborrheic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kamedis Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional, open label, Safety/Efficacy Study | Experimental | Device: SEBORRHEAMEDIS Face CreamSEBORRHEAMEDIS Face Cream Interventional 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEBORRHEAMEDIS Face CreamSEBORRHEAMEDIS 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. | Device | Interventional, open label, Safety/Efficacy Study |
Primary outcome
Improvement of overall ISGA. Descriptive Name of scale. Physician dermatology evaluation.
Time frame: Days 42
3 secondary outcomes
Improvement of erythema, desquamation on the target area. Physiological parameter. Physician dermatology evaluation.
Time frame: Days 0, 14, 28 and 42
Improvement of pruritus. Physiological parameter. Assessed by subject.
Time frame: Days 0, 14, 28 and 42
Number and severity of Adverse Events
Time frame: Days 0, 14, 28 and 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Derived from this study: PubMed 28458770Barak-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubén del Rio Gil, MD principal investigator
Hospital de l'Esperit Sant
Questions about this trial
What is this clinical trial studying?
A study testing SEBORRHEAMEDIS Face Cream in people with Seborrheic Dermatitis, run by Kamedis Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of overall ISGA. Descriptive Name of scale. Physician dermatology evaluation. (time frame: Days 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02656368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.