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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01174511
First received: August 2, 2010
Last updated: July 3, 2011
Last verified: July 2010
  Purpose

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 Intervention Phase
ATOPIC DERMATITIS
Drug: A -1 Cool Cream,Vaselin ointment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Clinical Trial Study for Evaluation of A-1 Cool Cream Efficacy for Treatment Patients With Atopic Dermatitis

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Evaluation of A-1 cool treatment by TIS score [ Time Frame: 5 DAYS ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174511

Contacts
Contact: LEMSTER NATALYA, MD 97226776114 LEMSTER20@YAHOO.COM
Contact: INGBER ARIEH, PROF. 97226776114 aingber@live.com

Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Arieh Ingber - Head of Department of Dermatology and Venereology - Hadassah Medical Center, Hadassah Medical Organization, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT01174511     History of Changes
Other Study ID Numbers: 0124-10-HMO-ctil
Study First Received: August 2, 2010
Last Updated: July 3, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
ATOPIC DERMATITIS
A-1 COOL CREAM

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014