A Phase 4 interventional study of Investigational OTC Cream and Cosmetic Eczema Cream in Dermatitis, Atopic and Eczema, sponsored by Procter & Gamble Beauty. Completed at 1 site in United States. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-10-05.
Sponsored by Procter & Gamble Beauty · Phase 4, Interventional, and Treatment
This is a 13 week randomized, double blind, parallel group, in home use study among approximately 60 male and female subjects, ages 12 to 65 years old inclusive, with atopic dermatitis (AD) SCORAD >16. Treatment group assignments will be balanced by disease severity, age, and body location of AD lesions. The study will consist of a 1 week washout phase and 12 week treatment phase. During the washout phase, subjects will be provided with a bar soap for bathing and showering and must refrain from using any other products on their body (excluding the face) including topical corticosteroids, ointments, lotions, sunscreens, etc. During the treatment phase, subjects will be randomized to 1 of 4 test legs. Throughout the treatment phase, the subjects will be required to use only the provided bar soap for bathing and showering and will apply their test product twice per day, once in the morning and once in the evening. No additional creams, moisturizers, lotions or cleansers other than those provided will be permitted for the duration of the study. Normal facial or hair care products are permitted, however, they must not contain anti-bacterial ingredients (e.g. antidandruff shampoo, acne products, etc).
SCORAD, EASI and PGA will incorporate whole body assessments. However, at the Baseline visit, subjects will have an active inflammatory lesion site and adjacent non-lesion, non-inflammatory site identified and marked for all instrumental and biopsy evaluations at Baseline and subsequent visits. Instrumental evaluations, imaging, expert visual grading and self-assessments will be performed throughout the study. Tolerability will be evaluated by incidence of AE's (defined per CTCAE), exacerbation of AD lesions, application site reactions/infections, and lab evaluations throughout the study. There will be additional consumption and compliance checks as well as dermatologic evaluations to ensure the subject's condition does not become extensively worse at each visit. A subset of subjects will have 2mm punch biopsies collected from the designated lesion and non-lesion sites at 3 time points throughout the study. The subset of subjects will be determined by subject willingness to participate in the biopsy portion as well as dermatologic evaluation and determination of biopsy candidacy.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 53 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →This is the only study on the registry with Procter & Gamble Beauty as lead sponsor.
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Exclusion Criteria:
Investigational OTC Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and anywhere else the patient would apply their ordinary body moisturizer.
Drug: Investigational OTC Cream
Placebo Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and anywhere else the patient would apply their ordinary body moisturizer.
Other: Placebo Cream
Cosmetic Eczema Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and anywhere else the patient would apply their ordinary body moisturizer.
Other: Cosmetic Eczema Cream
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 4 weeks to atopic dermatitis lesions and then on any new lesions that appear for 4 weeks and as directed by the study doctor. Placebo Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, anywhere the patient would apply their ordinary body moisturizer except atopic dermatitis lesions.
Drug: 0.05% Desonide Cream · Other: Placebo Cream
Also known as: CeraVe
Also known as: Actavis
SCORAD (Severity Scoring of Atopic Dermatitis)
Dermatologic assessment and scoring of atopic dermatitis lesion severity
Time frame: Change from Baseline at Week 12
SCORAD (Severity Scoring of Atopic Dermatitis)
Dermatologic assessment and scoring of atopic dermatitis lesion severity
Time frame: Change from Baseline at Week 2
SCORAD (Severity Scoring of Atopic Dermatitis)
Dermatologic assessment and scoring of atopic dermatitis lesion severity
Time frame: Change from Baseline at Week 4
SCORAD (Severity Scoring of Atopic Dermatitis)
Dermatologic assessment and scoring of atopic dermatitis lesion severity
Time frame: Change from Baseline at Week 8
Plan to share: No
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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