None listed
Conditions
Brief summary
This clinical trial is for testing a natural cream for relieving the symptoms of eczema
Interventions
Atopis skin cream which contains the extract DEC033 at 10% (contains peptilipids and fatty acids), cetearyl olivate, sorbitan olivate, shea butter, safflower oil, macadamia oil, glycerine, Vitamin E, geogard (preservative), Tangerine Oil, deionised water.
The cream is applied topically twice daily to the affected areas for four weeks. The cream is applied liberally. In the previous clinical trial tubes were returned at each visit and weighed. The subjects used on average 1.3g/day. A daily diary
Atopis skin cream which contains the extract DEC033 at 10% (contains peptilipids and fatty acids), cetearyl olivate, sorbitan olivate, shea butter, safflower oil, macadamia oil, glycerine, Vitamin E, geogard (preservative), Tangerine Oil, deionised water. The cream is applied topically twice daily to the affected areas for four weeks. The cream is applied liberally. In the previous clinical trial tubes were returned at each visit and weighed. The subjects used on average 1.3g/day. A daily diary is also used to track usage.
Sponsors
Decima Health Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy male or female between 16 and 70 years of age. 2. Subjects with mild to moderate eczema; which will be determined using the Eichenfield Revised Criteria of Hannafin and Rajka at screening visit. 3. Judged by the Investigator to be in general good health on the basis of medical history. 4. Agree to use the Study-supplied investigational product as the only body cosmetic applied to irritated skin. 5. Agree to stop all dietary supplements including probiotics, dermatological medications and creams for eczema, during the entire length of the study 6. Agree not to change their current diet or exercise program during the entire study period. 7. Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator. 8. Females of child bearing potential must agree to use appropriate birth control methods during the entire study period.
Exclusion criteria
a) Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic, or biliary disorder. b) Known allergy or sensitivity to Herbal products c) Use of systemic corticosteroids in the past 30 days. d) History of malignancy in the past two years. e) Recent history of alcoholism (within 12 months) or strong potential for alcohol or substance abuse. f) Participation in a clinical study with exposure to any non-registered drug product within 30 days prior. g) Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, to comply with the study protocol or which might confound the interpretation of the study results or put the person at undue risk. Including subjects who are bed or wheelchair-bound. h) Pregnant or lactating during the duration of the study. i) Smoking – must be nonsmoker for at least 12 months prior to screening.
Outcome results
None listed