A Phase 1/2 interventional study of A -1 Cool Cream,Vaselin ointment in ATOPIC DERMATITIS, sponsored by Hadassah Medical Organization. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-06.
Sponsored by Hadassah Medical Organization · Phase 1/2, Interventional, and Supportive care
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.
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's planned enrollment of 30 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
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
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
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.
Time frame: 5 DAYS
No study locations are listed for this record.
This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization