The purpose of this study is to evaluate the safety and tolerability, as well as
effectiveness, with regards to the order of application for Locoid Lipocream and Hylatopic
Plus cream in patients with atopic dermatitis (AD), which is a type of skin rash. Topical
skin barrier repair therapies (BRT) that are plain moisturizing creams/lotions with added
lipids (fats/oils), such as Hylatopic Plus cream, have emerged as an effective addition to
the the treatment of atopic dermatitis. BRTs are often used along with topical steroids
(medicated creams), such as Locoid lotion, on skin with AD, and as a monotherapy (single
treatment) on both non-diseased and diseased skin. Since BRTs help to restore components of
skin that are absent in skin with AD, it is believed that long-term BRT use may reduce
further development of further AD. This is an open-label, single site study.
Inclusion Criteria:
- subjects of at least 3 months of age.
- clinical diagnosis of stable mild to moderate AD using the Hanifin and Rajka criteria
for diagnosing AD
- AD lesions of similar size and severity of bilateral anatomic location
- a SPGA score of 2 or 3 and at least 10% BSA involvement at baseline
- in good health, without evidence of disease process(es) that would present patient
safety concerns or confounding factors for assessment of study objectives
- able and willing to understand and sign an informed consent (or if applicable parent
or legal guardian sign an informed consent),
- able and willing to agree to requirements and restrictions of the study
- Subjects who are willing to discontinue all systemic corticosteroids,
immunomodulators, ultra violet light therapy or other medication (investigational or
otherwise) that may have an effect on atopic dermatitis disease progression for 30
days prior to the baseline measurement.
- Subjects on a stable maintenance therapy (at least 30 days of use prior to baseline)
of antihistamines and/or nasal spray containing corticosteroids for the treatment of
bronchial asthma or allergic rhinitis, and antibiotics for the treatment of acne will
be allowed.
- Subjects who are willing to discontinue use of topical treatments for AD including,
but not limited to, corticosteroids, immunomodulators, vitamin D treatments,
retinoids, topical antihistamines for at least 14 days prior to baseline
- Subjects who are willing to discontinue use of oral antibiotic therapy for at least 7
days prior to baseline, unless prescribed for acne treatment as previously described
- Subjects with no known allergy to any of the study product ingredients
- Women of childbearing potential must be willing to use a form of birth control during
the study. For the purpose of this study, the following are considered acceptable
methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier
methods (e. g., condom and spermicide) and abstinence.
Exclusion Criteria:
- immunocompromised patients, or subjects with extensive disease that could not
reasonably be controlled with topical therapy
- history or evidence of other conditions that would interfere with the evaluation of
the study medication
- subjects desiring excessive or prolonged exposure to UV light (e. g. sunlight/tanning
beds) during the study
- Use of topical medications for AD or any other medical condition.
- Subjects currently involved in another clinical research study.
- Subjects, who are pregnant, breast feeding or planning a pregnancy.
- Subjects with clinically significant unstable medical or mental disorders.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
