Clinical trial: Efficacy and Steroid Sparing Potential Study of DGLA Cream in Early Childhood Patients With Moderate to Severe Atopic Dermatitis (NCT03676933)

Eligibility criteria:
Inclusion Criteria:

          1. Female and male infants aged 3-12 months.

          2. Diagnosis of atopic dermatitis according to the Hanifin and Rajka Criteria.

          3. Patients with moderate to severe atopic dermatitis (IGA ≥3)

          4. Patients with atopic dermatitis covering a minimum of 10% of the body surface area at
             baseline.

          5. Atopic Dermatitis is stable for the past 7 days, in the opinion of the investigator.

          6. The patient's parents are able to apply the study product twice a day (each morning
             and evening) for a consecutive period of 63 days.

          7. Patients who have completed the tolerability patch test without any adverse effects
             after 72 hours.

        Exclusion Criteria:

          1. Any clinically significant controlled or uncontrolled medical condition that would, in
             the opinion of the investigator, put the patient at undue risk or interfere with
             interpretation of study results.

          2. Clinically significant impairment of renal or hepatic function.

          3. Clinically significant immunodeficiency.

          4. Use of systemic antibiotics less than 2 weeks prior to Baseline Visit (Day 0).

          5. Other skin conditions that might interfere with atopic dermatitis diagnosis and/or
             evaluation (such as psoriasis or current viral, bacterial and fungal skin infections).

          6. History of intolerance to any ingredient in DS107E DGLA cream or Vehicle cream
             (including the tolerability patch test performed at the Screening Visit) or
             intolerance to any ingredient in Locoid® Ointment (hydrocortisone butyrate 0.1%).

          7. Use of systemic treatments that could affect atopic dermatitis less than 4 weeks prior
             to Baseline Visit (Day 0), e.g. oral corticosteroids; Intranasal corticosteroids and
             inhaled corticosteroids for stable medical conditions are allowed.

          8. Treatment with any experimental drug within 30 days prior to Day 0 Visit (Baseline),
             or 5 half-lives (whichever is longer).

          9. Excessive sun exposure or other ultraviolet (UV) light sources 4 weeks prior to Day 0
             Visit (Baseline) and/or is planning a trip to sunny climate or other UV sources
             between screening and follow-up visits.

         10. Use of any topical medicated treatment for atopic dermatitis 2 weeks prior to start of
             treatment/Day 0 Visit (Baseline), including but not limited to topical
             corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach
             baths.

         11. Use of topical products containing ceramides 2 weeks prior to Day 0.

         12. Medical history of chronic infectious disease (e.g., hepatitis B, hepatitis C or
             infection with human immunodeficiency virus).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
Subject must be at most 12 Months

Patient description (medical language): A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago.  A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy.  The patient has had a few upper respiratory infections but no major illnesses.  Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance.  Vital signs and milestone examination are within normal limits.  Similar findings are observed on the cheeks and proximal upper extremities.  The diaper area is clear, and no mucosal lesions are present.

Patient description (patient's own words): I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions.

Does the patient match the trial criteria? Contradiction