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

July 3, 2011 updated by: Hadassah Medical Organization

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of A-1 cool treatment by TIS score
Time Frame: 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.
5 DAYS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ANTICIPATED)

November 1, 2012

Study Completion (ANTICIPATED)

November 1, 2012

Study Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 2, 2010

First Posted (ESTIMATE)

August 3, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 3, 2011

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0124-10-HMO-ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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