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
About this trial
This is an interventional supportive care trial for ATOPIC DERMATITIS focused on measuring ATOPIC DERMATITIS, A-1 COOL CREAM
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.
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
NCT ID
NCT01174511
First Posted
August 2, 2010
Last Updated
July 3, 2011
Sponsor
Hadassah Medical Organization
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
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