Ignite Creation Date:
2024-05-06 @ 3:24 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02286700
Status:
UNKNOWN
Last Update Posted:
2014-11-11
First Post:
2014-11-04
Brief Title:
Skin Effects of a Topical Amino Acid Moisturizing Cream and Desonide in Atopic Dermatitis
Sponsor:
NeoStrata Company Inc
Organization:
NeoStrata Company Inc
Study Overview
Official Title:
A Randomized Double-Blind Active Control 5 Week Study to Evaluate the Safety and Skin Effects of A New Twice-daily Topically Applied Amino Acid Moisturizing Cream vs Desonide Cream in Adult Atopic Dermatitis
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the effects of an amino acid moisturizing cream and desonide cream in reducing skin symptoms associated with ADeczema in subjects with mild to moderate atopic dermatitiseczema
Detailed Description:
This is a double-blind randomized study comparing the effects of an amino acid moisturizing cream and desonide cream in reducing skin symptoms associated with ADeczema in subjects with mild to moderate atopic dermatitiseczema Atopic dermatitis AD also known as Eczema is a chronic inflammatory skin disease that most commonly affects infants and children with a prevalence of 10-20 in children as compared to 1-3 in adults Patients with AD have dry irritated skin and often experience severe pruritus Treatment of AD involves avoidance of triggers and infectious agents cutaneous hydration control of pruritus and anti-inflammatory agents Topical calcineurin inhibitors and steroids are commonly used prescription anti-inflammatory treatments Unfortunately there are potential side effects of long-term topical glucocorticoid use including skin atrophy development of striae perioral dermatitis acne and even hypothalamic-pituitary-adrenal axis suppression However many moisturizers are available without a prescription to soothe skin and reduce symptoms associated with ADeczema via increased hydration improved barrier function and anti-irritancy effects The study cream being compared to desonide is a cosmetic moisturizing formulation that contains a cosmetic amino acid dipeptide eg contains 2 amino acids This study is being conducted to understand the benefits of the amino acid dipeptide moisturizing cream versus dermatologist-prescribed desonide cream in reducing the symptoms associated with ADeczema in order to evaluate its potential use in the eczema care market For this study approximately 60 males and females 18 years of age and older who are in general good health but diagnosed with mild to moderate ADeczema will be recruited screened and fully consented with the goal of enrolling up to 42 evaluable subjects The 42 Subjects 21 subjects per group will be randomly and equally assigned to either one of 2 treatment groups of amino acid moisturizing cream or desonide cream Neither study subjects nor study staff will be aware of the treatment assigned The subjects will be asked to participate for approximately 5 weeks over 5 study visits ScreeningBaseline Weeks 1-3 Treatment Period Regression weeks 4 5 Each subject will receive one 15 gram blinded study cream at each treatment visit to apply twice daily at home for 3 weeks a 2-week regression phase of no study cream will follow the treatment phase A predetermined target lesion will be assessed at each time point via established clinical grading scales including Target lesion Atopic Dermatitis Severity Index TADSI Eczema Area Severity Index EASI Static IGA of targeted lesion Total IGA PGA and Body Surface Area involvement All grading will be completed by the principal or sub-investigators Photographs will also be taken at each time point to assess changes during the treatment and regression phases Other established scales will be utilized to collect patient perception of skin effects such as Patient-Oriented Eczema Measure POEM subjects assessment of pruritus VAS a self-assessment questionnaire will be utilized to collect information on perceived benefits and product aesthetics This study has been IRB approved and is scheduled to begin November of 2014 at Massachusetts General Hospital specifically at the Clinical Unit for Research Trials in Skin CURTIS under principal investigator Alexandra B Kimball MD The study is being sponsored by NeoStrata Company Inc Princeton NJ
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None