Evaluation of A-1 Cool Cream Efficacy for Treatment Atopic Dermatitis
Clinical Trial Study for Evaluation of A-1 Cool Cream Efficacy for Treatment Patients With Atopic Dermatitis
1 other identifier
interventional
30
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2011
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2010
CompletedFirst Posted
Study publicly available on registry
August 3, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJuly 6, 2011
July 1, 2010
1.3 years
August 2, 2010
July 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
A-1 COOL cream
EXPERIMENTALA 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
Vaselin ointment
PLACEBO COMPARATORUsing the study as placebo.
Interventions
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
Eligibility Criteria
You may qualify if:
- patient with atopic dermatitis,
- Hebrew-speaking men and women,
- over 18 years old.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 2, 2010
First Posted
August 3, 2010
Study Start
July 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
July 6, 2011
Record last verified: 2010-07