8-Week Atopic Dermatitis (AD) Treatment Study
Overview
- Phase
- Phase 3
- Intervention
- Investigational OTC Cream
- Conditions
- Atopic Dermatitis Eczema
- Sponsor
- Procter and Gamble
- Enrollment
- 65
- Locations
- 2
- Primary Endpoint
- Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Moderate Atopic Dermatitis
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a study to investigate the clinical effectiveness of the Sponsor's experimental cream treatment on eczema as measured by visual grading of SCORAD (scoring of atopic dermatitis).
Detailed Description
This will be a 9-week, randomized, double blind, parallel comparison study consisting of a 1-week washout phase followed by an 8-week treatment phase. This study will be executed by one clinical research company utilizing two test sites and up to 62 subjects with moderate or severe atopic dermatitis, ages 12-65, will be enrolled. Subjects that are enrolled will be placed on one of three products (e.g. Sponsor's Experimental Cream Treatment, a basic moisturizer, or a positive control - Desonide) and will be required to use the assigned product twice a day for the duration of the 8-week treatment phase.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Is a generally healthy, male or female, 12-65 years old, inclusive;
- •Diagnosis of moderate or greater Atopic Dermatitis as determined by SCORAD (SCORAD \>=25);
- •Is able to read and understand instructions in English.
Exclusion Criteria
- •Is currently participating or has participated in another interventional clinical study in the past 2 weeks;
- •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;
Arms & Interventions
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.
Intervention: Investigational OTC Cream
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.
Intervention: Placebo Cream
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.
Intervention: 0.05% Desonide
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.
Intervention: Placebo Cream
Outcomes
Primary Outcomes
Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Moderate Atopic Dermatitis
Time Frame: Baseline to Week 8
SCORAD (Severity Scoring of Atopic Dermatitis) Change from Baseline to Week 8 of atopic dermatitis lesion as measured by the Scoring of Atopic Dermatitis (SCORAD). SCORAD is a composite severity index comprising a) the amount/extent of body area affected; b)b) 2 subjective symptom of pruritus (10 pts VAS) and sleep disturbance measured (10 pts VAS); and c) 6 disease intensity assessments \[Dryness/Scaling, Erythema, Excoriation, Induration/Papulation, Lichenification and Oozing/ Weeping/Crusting, each graded in 3pts TIS from 0 (None) to 3 (Severe). A SCORAD score ranges from 0 (No AD present) to 103 SCORAD is calculated: Extent 7\*Intensity SCORAD = --------- + ---------------- + Subjective 5 2
Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Severe Atopic Dermatitis
Time Frame: Baseline to Week 8
SCORAD (Severity Scoring of Atopic Dermatitis) Change from Baseline to Week 8 of atopic dermatitis lesion as measured by the Scoring of Atopic Dermatitis (SCORAD). SCORAD is a composite severity index comprising a) the amount/extent of body area affected; b)b) 2 subjective symptom of pruritus (10 pts VAS) and sleep disturbance measured (10 pts VAS); and c) 6 disease intensity assessments \[Dryness/Scaling, Erythema, Excoriation, Induration/Papulation, Lichenification and Oozing/ Weeping/Crusting, each graded in 3pts TIS from 0 (None) to 3 (Severe). A SCORAD score ranges from 0 (No AD present) to 103 SCORAD is calculated: Extent 7\*Intensity SCORAD = --------- + ---------------- + Subjective 5 2