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

Hadassah Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: ATOPIC DERMATITIS

Treatments: Drug: A -1 Cool Cream,Vaselin ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT01174511

0124-10-HMO-ctil

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

30 participants in 2 patient groups, including a placebo group

A-1 COOL cream

Experimental group

Description:

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

Treatment:

Drug: A -1 Cool Cream,Vaselin ointment

Vaselin ointment

Placebo Comparator group

Description:

Using the study as placebo.

Treatment:

Drug: A -1 Cool Cream,Vaselin ointment