A randomised double blinded placebo controlled study investigating Atopis for the improvement of skin health in subjects with eczema

Not Applicable

Completed

• Conditions: Eczema; atopic dermatitis; Skin - Dermatological conditions; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12615000920594
• Lead Sponsor: Decima Health Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Change in redness - as assessed using SCORAD (Visual Analog Scale) and Dermatological Examination by the site investigator<br>[Subjects are assessed at baseline, week 2 and week 4 for changes between timepoints.];Change in severity scoring of atopic dermatitis (SCORAD)[The subjects are assessed at time 0 baseline, week 2 and week 4 for changes in SCORAD];Change in itching - as assessed using SCORAD (Visual Analog Scale) and Dermatological Examination by the site investigator<br>[The subjects are assessed at time 0 baseline, week 2 and week 4 for changes in SCORAD]

Secondary Outcome Measures

Name	Time	Method
Change in the the number of eczema skin lesions - these are measured (length, width, location) by the site investigator and documented using the Dermatological examination documentation form.[The subjects are assessed by the site investigator at time 0 baseline, week 2 and week 4 for changes in length, width and number of lesions];Change in scaling - The subjects are assessed by the site investigator at time 0 baseline, week 2 and week 4 and assessed using visual analogue scale[The subjects are assessed for changes at time 0 baseline, week 2 and week 4]