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

ATOPIC DERMATITIS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01174511
• Other study ID #: 0124-10-HMO-ctil
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: August 2, 2010
• Last updated: July 3, 2011
• Start date: July 2011
• Est. completion date: November 2012

Study information

• Verified date: July 2010
• Source: Hadassah Medical Organization
• Contact: LEMSTER NATALYA, MD
• Phone: 97226776114
• Email: LEMSTER20[@]YAHOO.COM
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• ATOPIC DERMATITIS
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of A-1 cool treatment by TIS score	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	No

External Links

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