Clinical trial: Studies of Skin Microbes in Healthy People and in People With Skin Conditions (NCT00605878)

Eligibility criteria:
-  INCLUSION CRITERIA:

        Inclusion Criteria for all groups

        Must have a primary care professional who will continue standard of care/evaluation in
        tandem with the protocol to whom information and recommendations can be communicated.

        Inclusion Criteria for Group 1: Healthy Volunteers

        Adult males or females aged 18-50 at time of enrollment.

        Inclusion Criteria for Group 2: AD patients

        A. Confirmed diagnosis of AD (UK Working Party s Diagnostic Criteria)24

        B. Moderate to severe AD SCORAD greater than or equal to 25(25)

        C. Greater than or equal to 1 affected antecubital (or popliteal) fossae at time of
        enrollment to serve as a target site.

        Inclusion Criteria for Group 3: Healthy (pediatric) Controls

        A. Males or females 2 18 years of age.

        Inclusion Criteria for Groups 4, 5, & 6: AD/HIES/WAS/DOCK8 patients

        A. Must have mutation-proven diagnosis, with or without eczematous dermatitis.

        EXCLUSION CRITERIA:

        Exclusion Criteria for all groups:

          1. Any subjects with unstable or uncontrolled or chronic medical conditions requiring
             treatment or hospitalization. Individual determinations will be made at the discretion
             of the medical investigator.

          2. Any subjects receiving or planning to receive an IND agent, ultraviolet light therapy,
             monoclonal antibodies, or systemic immunosuppressants < 7 days or 5 half-lives
             (whichever is the longer time period) of initiating this protocol.

          3. Any subjects who have cancer, and are currently or have previously received treatment
             with chemotherapy or radiation for treatment of malignancies within the previous 6
             months.

          4. Any subject with a history of bone marrow transplant or gene therapy.

             Exclusion Criteria specific for Group 2: AD patients

             A. Unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at
             least 7 days prior to body site sampling. Unable to temporarily discontinue use of
             topical steroids or calcineurin inhibitors for greater than or equal to 7 days to
             small areas of skin intended for sampling. (Topical therapies/emollients for AD may be
             continued to non-adjacent, nontarget sites.)

             B. Underlying immunodeficiency, either as primary disease or secondary to treatment.

             Exclusion Criteria specific for Groups 4, 5, & 6: HIES/WAS/DOCK8 patients:

             A. Unable to remain off topical steroids and emollients for preferably 7 days but at
             least 24 hours prior to body site sampling.

             Exclusion Criteria specific for Groups 1 & 3: Healthy Volunteers and Healthy
             (pediatric) Controls:

             A. Underlying immunodeficiency, either as primary disease or secondary to treatment.

             B. Other documented chronic dermatologic disease, such as AD or psoriasis that may
             interfere with evaluation of the cutaneous microbiome. Common transient conditions,
             such as acne, are permissible.

             C. Subjects who provide direct healthcare or reside in healthcare facilities or in
             non-hospital settings such as assisted living facilities, homeless shelters, jails and
             prisons as well as subjects with frequent exposure to laboratory animals.

             D. Subjects with asthma.

          5. Any female with symptoms and/or serum hormone levels consistent with perimenopause
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 2 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Contradiction