search
Back to results

Evaluation of A-1 Cool Cream Efficacy for Treatment Atopic Dermatitis

Primary Purpose

ATOPIC DERMATITIS

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
A -1 Cool Cream,Vaselin ointment
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ATOPIC DERMATITIS focused on measuring ATOPIC DERMATITIS, A-1 COOL CREAM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient with atopic dermatitis,
  • Hebrew-speaking men and women,
  • over 18 years old.

Exclusion Criteria:

  • hospital where the diagnosis of atopic dermatitis is not sure,
  • patients under the age of 18, pregnant women, no - helpless, soldiers and prisoners,
  • patients with atopic dermatitis treated with systemic preparations such as cyclosporine, steroids, antibiotics, methotrexate, biological preparations.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    A-1 COOL cream

    Vaselin ointment

    Arm Description

    A research product - A-1 COOL cream contain herbal medicine plants basically : WATER PETROLATUM WILD YAM (DIOSCOREA VILLOSA) EXTRACT SORBITAN SESQUIOLEATE CALENDULA OFFICINALIS EXTRACT MINERAL OIL ARNICA MONTANA EXTRACT MICROCRYSTALLINE WAX LICORICE (GLYCYRRHIZA GLABRA) EXTRACT DECYL OLEATE DICOCOYL PENTAERYTHRITYL DISTEARYL CITRATE BEESWAX ALUMINUM STEARATES

    Using the study as placebo.

    Outcomes

    Primary Outcome Measures

    Evaluation of A-1 cool treatment by TIS score
    Initially, we will evaluate the disease severity in all the research subjects by SCORAD SCORE and TIS score.Thereafter we will apply to each subject's flexor aspects of the upper or lower limbs on one side the research product and on the other the placebo.This treatment will be given twice a day at specific times for 5 days. As ameasure to evaluate the efficacy of A-1 COOL treatment wiil be use the Three- item severity score (TIS)- reviewer redness, edema ,scratch marks.Severity of these symptoms wiil be evaluated from 0 to 3 points scale.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 2, 2010
    Last Updated
    July 3, 2011
    Sponsor
    Hadassah Medical Organization
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01174511
    Brief Title
    Evaluation of A-1 Cool Cream Efficacy for Treatment Atopic Dermatitis
    Official Title
    Clinical Trial Study for Evaluation of A-1 Cool Cream Efficacy for Treatment Patients With Atopic Dermatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2011 (undefined)
    Primary Completion Date
    November 2012 (Anticipated)
    Study Completion Date
    November 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Atopic dermatitis (AD) is a chronic inflammatory skin disease, affecting 20% of all babies and children around the world. Diagnosis of atopic dermatitis is clinical and depends on the existence of at least two out of the four following criteria: itching, a chronic disease course with exacerbations and remission ,rash with characteristic distribution and shape , atopia of the patient or family by history. Initial treatment is based on keeping skin moist and avoiding a flare-provoking stimuli and allergens. The research product A-1 COOL is a skin cream approved by the Israeli Ministry of Health for cooling down of skin irritation. A-1 COOL is rich in herbal medicine ingredients and does not contain steroids.A-1 COOL can be beneficial in Atopic Dermatitis patients due to its following action mechanisms: sealing of the inflamed skin and retention of water, prevention of the itching cycle by keeping the skin moist, disinfection of the skin by the herbal ingredients.
    Detailed Description
    Atopic dermatitis (AD) is a chronic inflammatory skin disease, affecting 20% of all babies and children around the world. In 90% of the cases the disease first appears before the age of five and in 65% of the cases it is already apparent at infancy but it may occur at any age. Diagnosis of atopic dermatitis is clinical and depends on the existence of at least two out of the four following criteria: itching, a chronic disease course with exacerbations and remission ,rash with characteristic distribution and shape , atopia of the patient or family by history. Initial treatment is based on keeping skin moist and avoiding a flare-provoking stimuli and allergens. Topical ointments which grease the skin have shown and reduction of skin inflammation. These products can include active substances such as steroids and anti-inflammatory compounds. Systemic treatments for atopic dermatitis mainly include steroids and cyclosporine. The research product A-1 COOL is a skin cream approved by the Israeli Ministry of Health for cooling down of skin irritation. A-1 COOL is rich in herbal medicine ingredients and does not contain steroids.A-1 COOL can be beneficial in Atopic Dermatitis patients due to its following action mechanisms: sealing of the inflamed skin and retention of water, prevention of the itching cycle by keeping the skin moist, disinfection of the skin by the herbal ingredients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ATOPIC DERMATITIS
    Keywords
    ATOPIC DERMATITIS, A-1 COOL CREAM

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A-1 COOL cream
    Arm Type
    Experimental
    Arm Description
    A research product - A-1 COOL cream contain herbal medicine plants basically : WATER PETROLATUM WILD YAM (DIOSCOREA VILLOSA) EXTRACT SORBITAN SESQUIOLEATE CALENDULA OFFICINALIS EXTRACT MINERAL OIL ARNICA MONTANA EXTRACT MICROCRYSTALLINE WAX LICORICE (GLYCYRRHIZA GLABRA) EXTRACT DECYL OLEATE DICOCOYL PENTAERYTHRITYL DISTEARYL CITRATE BEESWAX ALUMINUM STEARATES
    Arm Title
    Vaselin ointment
    Arm Type
    Placebo Comparator
    Arm Description
    Using the study as placebo.
    Intervention Type
    Drug
    Intervention Name(s)
    A -1 Cool Cream,Vaselin ointment
    Intervention Description
    A- 1 Cool Cream applied to flexural aspects of the upper and lower limb on the one site of patient and placebo (Vaseline ointment) applied to other site of the upper and lower limb in the itch patient. Applying the ointment will be a regular time, twice a day for 5 consecutive days
    Primary Outcome Measure Information:
    Title
    Evaluation of A-1 cool treatment by TIS score
    Description
    Initially, we will evaluate the disease severity in all the research subjects by SCORAD SCORE and TIS score.Thereafter we will apply to each subject's flexor aspects of the upper or lower limbs on one side the research product and on the other the placebo.This treatment will be given twice a day at specific times for 5 days. As ameasure to evaluate the efficacy of A-1 COOL treatment wiil be use the Three- item severity score (TIS)- reviewer redness, edema ,scratch marks.Severity of these symptoms wiil be evaluated from 0 to 3 points scale.
    Time Frame
    5 DAYS

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient with atopic dermatitis, Hebrew-speaking men and women, over 18 years old. Exclusion Criteria: hospital where the diagnosis of atopic dermatitis is not sure, patients under the age of 18, pregnant women, no - helpless, soldiers and prisoners, patients with atopic dermatitis treated with systemic preparations such as cyclosporine, steroids, antibiotics, methotrexate, biological preparations.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    LEMSTER NATALYA, MD
    Phone
    97226776114
    Email
    LEMSTER20@YAHOO.COM
    First Name & Middle Initial & Last Name or Official Title & Degree
    INGBER ARIEH, PROF.
    Phone
    97226776114
    Email
    aingber@live.com

    12. IPD Sharing Statement

    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/19583684
    Description
    Katoh N.Future perspectives in the treatment of atopic dermatitis.

    Learn more about this trial

    Evaluation of A-1 Cool Cream Efficacy for Treatment Atopic Dermatitis

    We'll reach out to this number within 24 hrs