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

Phase 1

• Conditions: ATOPIC DERMATITIS
• Interventions: Drug: A -1 Cool Cream,Vaselin ointment

• Registration Number: NCT01174511
• Lead Sponsor: Hadassah Medical Organization

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.

Study Timeline

• Status Verified: 2010-07
• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-02
• Study First Posted: 2010-08-03
• Study Start: 2011-07
• Last Update Submitted: 2011-07-03
• Last Update Posted: 2011-07-06
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-1 COOL cream	A -1 Cool Cream,Vaselin ointment	A research product - A-1 COOL cream contain herbal medicine plants basically : 1. WATER PETROLATUM 2. WILD YAM (DIOSCOREA VILLOSA) EXTRACT 3. SORBITAN SESQUIOLEATE 4. CALENDULA OFFICINALIS EXTRACT 5. MINERAL OIL 6. ARNICA MONTANA EXTRACT 7. MICROCRYSTALLINE WAX 8. LICORICE (GLYCYRRHIZA GLABRA) EXTRACT 9. DECYL OLEATE 10. DICOCOYL PENTAERYTHRITYL DISTEARYL CITRATE 11. BEESWAX 12. ALUMINUM STEARATES
Vaselin ointment	A -1 Cool Cream,Vaselin ointment	Using the study as placebo.

Primary Outcome Measures

Name	Time	Method
Evaluation of A-1 cool treatment by TIS score	5 DAYS	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.