Atopic DermatitisPhase 4NCT01781663
Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD)
A Phase 4 study testing KAM2904 Face Cream, KAM3008 Body Lotion and petrolatum-based moisturizer in people with Atopic Dermatitis, run by Kamedis Ltd. at 1 site in Spain.
Trial summary
The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects treated with KAM2904 Face Cream and KAM3008… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- KAM2904 Face Cream, KAM3008 Body Lotion and petrolatum-based moisturizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2013to Jun 2014
- Phase
- Phase 4
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Male or female between 2 and 12 years of age
- The subject suffers from moderate atopic dermatitis (SCORAD<40) that is amenable to treatment
- Diagnosis of atopic dermatitis meets Hanifin's criteria (at least 3 basic features and at least 3 minor features)
- Atopic dermatitis is, in the opinion of the investigator, stable for the past 7 days
- The subject's parents are able to apply the study product twice a day (each morning and evening) for a consecutive period of 42 days
- The subject's parents agree that the subject will not change his/her lifestyle during the study period (including: regular body hygiene product (soap), the number of baths and showers per day, the laundry detergent and fabric softener used to wash clothes)
- The subject's parents agree to use only the test product during the study period
- The subject's legal guardian is able and willing to sign the informed consent form and to comply with the study regulations of this protocol
Who cannot join
- • The subject has another dermatological disease/condition that could interfere with the clinical evaluation, including infected atopic dermatitis lesions
- The subject has a previous history of allergy to cosmetic products or to any of the ingredients included in the tested formulations (Appendices 1 and 2)
- The subject received a topical or a systemic immune-modulator (such calcineurin inhibitors or cortico-steroids) for the treatment of atopic dermatitis, within 14 days prior to day 0
- The subject underwent phototherapy within 28 days prior to day 0
- The subject is expected to be extensively exposed to the sun during the trial
- The subject underwent any experimental treatment within 14 days prior to day 0
Trial locations and contacts
1 site in 1 country.
Miri Sani contact
Spain1 site, 1 recruiting
- Recruiting
Fundación Teknon
Barcelona
Dr. Carlos Marin, MD
Dr. Carlos Marin, MD
About this study
The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group), versus a group of subjects treated with a petrolatum-based moisturizer (the control group). Safety will be determined by the number and severity of Adverse Events Device-Related.
- Conditions
- Atopic Dermatitis
- Being tested
- KAM2904 Face Cream, KAM3008 Body Lotion, petrolatum-based moisturizer
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAM2904 Face CreamDevice
KAM3008 Body LotionDevice
petrolatum-based moisturizerOther
| Study group | Role | What they receive |
|---|---|---|
| KAM2904 Face Cream and KAM3008 Body Lotion | Experimental | A group treated with KAM2904 Face Cream and KAM3008 Body Lotion Receives: Device: KAM2904 Face Cream; Device: KAM3008 Body Lotion |
| petrolatum-based moisturizer | Sham comparator | control group Receives: Other: petrolatum-based moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Change in SCORAD (Scoring Atopic Dermatitis)
Measured: after 42 days of treatment
• Change in EASI (Eczema Area Severity Index)
Measured: after 42 days of treatment
• Change in the scoring of individual symptoms of atopic dermatitis
Measured: after 42 days of treatment
Secondary outcomes (4)
• Trend in the change of SCORAD
Measured: after 42 days of treatment
• Trend in the change of EASI
Measured: after 42 days of treatment
• Trend in the change of individual symptoms of atopic dermatitis
Measured: after 42 days of treatment
• Safety of KAM2904 Face Cream and KAM3008 Body Lotion
Safety will be measured by the number and severity of Device-Related Adverse Events.
Measured: days D14, D28, D42 and unscheduled visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kamedis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Eli Sprecher, MD, Principal investigator, Tel Aviv Soraski Medical Center - Dermatology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781663
- Sponsor's protocol ID
- KAM-ATOPIC-01
- Status last verified
- Jul 2013
- First submitted
- 29 Jan 2013
- Last updated
- 30 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD)
- ClinicalTrials.gov ID
- NCT01781663
- Acronym / sponsor ID
- KAM-ATOPIC-01
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Kamedis Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2014 (estimated)
- First posted
- 1 Feb 2013 (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.
The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group), versus a group of subjects treated with a petrolatum-based moisturizer (the control group). Safety will be determined by the number and severity of Adverse Events Device-Related.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KAM2904 Face Cream and KAM3008 Body Lotion | Experimental | Device: KAM2904 Face Cream, Device: KAM3008 Body LotionA group treated with KAM2904 Face Cream and KAM3008 Body Lotion |
| petrolatum-based moisturizer | Sham comparator | Other: petrolatum-based moisturizercontrol group |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- • Male or female between 2 and 12 years of age
Key exclusion criteria (6 listed)
- • The subject has another dermatological disease/condition that could interfere with the clinical evaluation, including infected atopic dermatitis lesions
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 |
|---|---|---|
| KAM2904 Face Cream | Device | KAM2904 Face Cream and KAM3008 Body Lotion |
| KAM3008 Body Lotion | Device | KAM2904 Face Cream and KAM3008 Body Lotion |
| petrolatum-based moisturizer | Other | petrolatum-based moisturizer |
Primary outcome
• Change in SCORAD (Scoring Atopic Dermatitis)
Time frame: after 42 days of treatment
• Change in EASI (Eczema Area Severity Index)
Time frame: after 42 days of treatment
• Change in the scoring of individual symptoms of atopic dermatitis
Time frame: after 42 days of treatment
4 secondary outcomes
• Trend in the change of SCORAD
Time frame: after 42 days of treatment
• Trend in the change of EASI
Time frame: after 42 days of treatment
• Trend in the change of individual symptoms of atopic dermatitis
Time frame: after 42 days of treatment
• Safety of KAM2904 Face Cream and KAM3008 Body Lotion
Time frame: days D14, D28, D42 and unscheduled visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
- Sponsor's siteLink provided by the sponsor.
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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.
Miri Sani contact
Prof. Eli Sprecher, MD principal investigator
Tel Aviv Soraski Medical Center - Dermatology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing KAM2904 Face Cream, KAM3008 Body Lotion and petrolatum-based moisturizer in people with Atopic Dermatitis, run by Kamedis Ltd. at 1 site in Spain.
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miri Sani (mirisani@013.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Change in SCORAD (Scoring Atopic Dermatitis) (time frame: after 42 days of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2014.