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

NCT ID: NCT01174511

Last Updated: 2011-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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ATOPIC DERMATITIS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A-1 COOL cream

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

Group Type EXPERIMENTAL

A -1 Cool Cream,Vaselin ointment

Intervention Type DRUG

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

Vaselin ointment

Using the study as placebo.

Group Type PLACEBO_COMPARATOR

A -1 Cool Cream,Vaselin ointment

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Organization, Jerusalem, Israel

Central Contacts

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LEMSTER NATALYA, MD

Role: CONTACT

97226776114

INGBER ARIEH, PROF.

Role: CONTACT

97226776114

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/19583684

Katoh N.Future perspectives in the treatment of atopic dermatitis.

Other Identifiers

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0124-10-HMO-ctil

Identifier Type: -

Identifier Source: org_study_id

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