Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atopic Dermatitis |
Device: KAM2904 Face Cream Device: KAM3008 Body Lotion Other: petrolatum-based moisturizer |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
- • Change in SCORAD (Scoring Atopic Dermatitis) [ Time Frame: after 42 days of treatment ] [ Designated as safety issue: No ]
- • Change in EASI (Eczema Area Severity Index) [ Time Frame: after 42 days of treatment ] [ Designated as safety issue: No ]
- • Change in the scoring of individual symptoms of atopic dermatitis [ Time Frame: after 42 days of treatment ] [ Designated as safety issue: No ]
- • Trend in the change of SCORAD [ Time Frame: after 42 days of treatment ] [ Designated as safety issue: No ]
- • Trend in the change of EASI [ Time Frame: after 42 days of treatment ] [ Designated as safety issue: No ]
- • Trend in the change of individual symptoms of atopic dermatitis [ Time Frame: after 42 days of treatment ] [ Designated as safety issue: No ]
- • Safety of KAM2904 Face Cream and KAM3008 Body Lotion [ Time Frame: days D14, D28, D42 and unscheduled visits ] [ Designated as safety issue: Yes ]Safety will be measured by the number and severity of Device-Related Adverse Events.
| Estimated Enrollment: | 56 |
| Study Start Date: | February 2013 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: KAM2904 Face Cream and KAM3008 Body Lotion
A group treated with KAM2904 Face Cream and KAM3008 Body Lotion
|
Device: KAM2904 Face Cream Device: KAM3008 Body Lotion |
|
Sham Comparator: petrolatum-based moisturizer
control group
|
Other: petrolatum-based moisturizer |
Eligibility| Ages Eligible for Study: | 2 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• 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
Exclusion Criteria:
• 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
Contacts and Locations| Contact: Miri Sani | mirisani@013.net |
| Spain | |
| Fundación Teknon | Recruiting |
| Barcelona, Spain | |
| Contact: Dr. Carlos Marin, MD | |
| Principal Investigator: Dr. Carlos Marin, MD | |
| Principal Investigator: | Prof. Eli Sprecher, MD | Tel Aviv Soraski Medical Center - Dermatology Unit |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kamedis Ltd. |
| ClinicalTrials.gov Identifier: | NCT01781663 History of Changes |
| Other Study ID Numbers: | KAM-ATOPIC-01 |
| Study First Received: | January 29, 2013 |
| Last Updated: | January 30, 2013 |
| Health Authority: | Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Petrolatum Emollients Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013