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Status unknownNCT01781663Updated Jan 30, 2014

Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD)

A Phase 4 interventional study of KAM2904 Face Cream and KAM3008 Body Lotion in Atopic Dermatitis, sponsored by Kamedis Ltd.. Status unknown at 1 site in Spain. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2014-01-30.

Sponsored by Kamedis Ltd. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
2 Years to 12 Years
Sex
All
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Study 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.

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Conditions studied

03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's planned enrollment of 56 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Kamedis Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All
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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
56 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceKAM2904 Face Cream
  • DeviceKAM3008 Body Lotion
  • Otherpetrolatum-based moisturizer
06

What researchers measure

Primary outcomes

  1. • Change in SCORAD (Scoring Atopic Dermatitis)

    Time frame: after 42 days of treatment

  2. • Change in EASI (Eczema Area Severity Index)

    Time frame: after 42 days of treatment

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

    Time frame: after 42 days of treatment

Secondary outcomes

  1. • Trend in the change of SCORAD

    Time frame: after 42 days of treatment

  2. • Trend in the change of EASI

    Time frame: after 42 days of treatment

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

    Time frame: after 42 days of treatment

  4. • Safety of KAM2904 Face Cream and KAM3008 Body Lotion

    Safety will be measured by the number and severity of Device-Related Adverse Events.

    Time frame: days D14, D28, D42 and unscheduled visits

07

Study locations

1 of 1 sites recruiting
  • Fundación Teknon
    Barcelona, Spain
    • Dr. Carlos Marin, MD · Contact
    • Dr. Carlos Marin, MD · Principal investigator
    Recruiting
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References and documents

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01781663
Lead sponsor
Kamedis Ltd.
Responsible party
Sponsor
First posted
Feb 1, 2013
Start date
Feb 2013
Primary completion
Jun 2014 (estimated)
Last update
Jan 30, 2014

Study contacts

Miri Sani
Contact
mirisani@013.net
Prof. Eli Sprecher, MD
principal investigator · Tel Aviv Soraski Medical Center - Dermatology Unit
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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