Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
65 participants
INTERVENTIONAL
2017-11-27
2018-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Investigational OTC Cream
Investigational Over the Counter (OTC) Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
Investigational OTC Cream
Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
Placebo Cream
Placebo Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
Placebo Cream
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
0.05% Desonide Cream
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
0.05% Desonide
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
Placebo Cream
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
Interventions
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Investigational OTC Cream
Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
0.05% Desonide
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.
Placebo Cream
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of moderate or greater Atopic Dermatitis as determined by SCORAD (SCORAD \>=25);
* Is able to read and understand instructions in English.
Exclusion Criteria
* Currently or has been diagnosed or treated for cancer in the past 5 years;
* Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or stable antihistamines for asthma or allergies);
* Has used systemic treatments that could affect AD within 30 days or 5 half- lives. (i.e. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids);
* Has a known hypersensitivity to any corticosteroid creams;
* Has been diagnosed with any allergies to Oat or derivatives;
* Has any active infections or has used antibiotics in the past 7 days;
* Has any physical attributes or skin conditions that might interfere with the clear visual or instrumental assessments.(i.e. cuts, sunburn, birth marks, tattoos, extensive scarring, excessive hair growth or acne);
* Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results;
* Has used any immunosuppressant drugs or immunotherapy within the past 30days or 5 half-lives;
* Is an employee of the sponsor company or clinical testing site;
* Is diabetic;
* Presents with the presence of an active or chronic allergic reaction as evidenced by an irregular white cell count determined by eosinophils \> 0.3 X 109/L at Screening Visit;
* Is planning a trip to a sunny climate, to use tanning booths or use other UV sources throughout the course of this study;
* Has a history of hypersensitivity to any substance in investigational preparation or to Desonide;
* Has any clinically significant medical condition or laboratory abnormality that would, in the opinion of the Investigator, put the patient at undue risk or interfere with the interpretation of the study results;
* Is dependent on oral medication for any skin disease/condition or could not, in the opinion of the Investigator tolerate the restriction of discontinuing the medicine as required in this study;
* Is currently pregnant or lactating or planning to become pregnant in the next 6 months;
* Has other skin conditions that might interfere with AD diagnosis and/or evaluation (i.e. psoriasis current active viral, bacterial and fungal skin infections) as assessed by the Investigator;
* Any other condition or factor the Investigator or their duly assigned representative believes may affect the ability of the subject to complete the study or the interpretation
12 Years
65 Years
ALL
No
Sponsors
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Procter and Gamble
INDUSTRY
Responsible Party
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Principal Investigators
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Amanda Salisbury, BSN
Role: STUDY_DIRECTOR
Wake Research, LLC
Locations
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Wake Research, LLC
Raleigh, North Carolina, United States
WR (Wake Research) ClinSearch
Chattanooga, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CSD2017168
Identifier Type: -
Identifier Source: org_study_id