NCT01781663

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Last Updated

January 30, 2014

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

January 29, 2013

Last Update Submit

January 29, 2014

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (3)

  • • Change in SCORAD (Scoring Atopic Dermatitis)

    after 42 days of treatment

  • • Change in EASI (Eczema Area Severity Index)

    after 42 days of treatment

  • • Change in the scoring of individual symptoms of atopic dermatitis

    after 42 days of treatment

Secondary Outcomes (4)

  • • Trend in the change of SCORAD

    after 42 days of treatment

  • • Trend in the change of EASI

    after 42 days of treatment

  • • Trend in the change of individual symptoms of atopic dermatitis

    after 42 days of treatment

  • • Safety of KAM2904 Face Cream and KAM3008 Body Lotion

    days D14, D28, D42 and unscheduled visits

Study Arms (2)

KAM2904 Face Cream and KAM3008 Body Lotion

EXPERIMENTAL

A group treated with KAM2904 Face Cream and KAM3008 Body Lotion

Device: KAM2904 Face CreamDevice: KAM3008 Body Lotion

petrolatum-based moisturizer

SHAM COMPARATOR

control group

Other: petrolatum-based moisturizer

Interventions

KAM2904 Face CreamDEVICE
KAM2904 Face Cream and KAM3008 Body Lotion
KAM3008 Body LotionDEVICE
KAM2904 Face Cream and KAM3008 Body Lotion
petrolatum-based moisturizerOTHER
petrolatum-based moisturizer

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Teknon

Barcelona, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Prof. Eli Sprecher, MD

    Tel Aviv Soraski Medical Center - Dermatology Unit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miri Sani

CONTACT

mirisani@013.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 1, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2014

Last Updated

January 30, 2014

Record last verified: 2013-07

Locations

ES(1)