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

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Unknown status

CT.gov ID

NCT01174511

Collaborator

(none)

Enrollment

Arms

16.1

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
ATOPIC DERMATITIS	Drug: A -1 Cool Cream,Vaselin ointment	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Clinical Trial Study for Evaluation of A-1 Cool Cream Efficacy for Treatment Patients With Atopic Dermatitis

Study Start Date :

Jul 1, 2011

Anticipated Primary Completion Date :

Nov 1, 2012

Anticipated Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A-1 COOL cream 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	Drug: A -1 Cool Cream,Vaselin ointment 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
Placebo Comparator: Vaselin ointment Using the study as placebo.	Drug: A -1 Cool Cream,Vaselin ointment 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

Arm

Intervention/Treatment

Experimental: A-1 COOL cream

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

Drug: A -1 Cool Cream,Vaselin ointment

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

Placebo Comparator: Vaselin ointment

Using the study as placebo.

Drug: A -1 Cool Cream,Vaselin ointment

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.