Efficacy and Tolerability of New Topical Formulations in Subjects With Atopic Dermatitis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Dermatology, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 12 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | March 2016 |
| End Date: | June 2016 |
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.
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.
Inclusion Criteria:
- Is a generally healthy, male or female, 12-65 years old, inclusive
- Diagnosis of moderate or greater Atopic Dermatitis as determined by the Physician's
Global Assessment (PGA of 3 or 4)
Exclusion Criteria:
- Is currently participating or has participated in another interventional clinical
study at this or any other facility 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 a known hypersensitivity to any corticosteroid creams.
- Has a known sensitivity to Epinephrine, Xylocaine or topical antibiotics.
- Has a wound healing or blood-clotting abnormality.
- 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 30 days or 5
half-lives.
- Is an employee of the Sponsor Company or clinical testing site.
- Is diabetic.
- 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 a history of keloid formation following skin injury.
- Is routinely taking anti-coagulant medications (i.e. Plavix, Coumadin, warfarin,
heparin, etc.)
- 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 of the results.
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