Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Glenmark Pharmaceuticals Ltd. India
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or non-pregnant, non-lactating female subjects 12 years of age and older.
Non-immunocompromised, with a clinical diagnosis of mild to moderate AD that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or for whom those treatments are not advisable.
Confirmed diagnosis of AD for at least 3 months using the diagnostic features as described by Hanifin and Rajka.
IGA score of 2 (mild) or 3 (moderate) and ≥ 5% BSA affected at baseline.
You may not be if
Active cutaneous bacterial, viral or fungal infection in any treatment area at baseline (e.g., clinically infected AD).
Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline and history or presence of skin conditions that would interfere with evaluations.
History or presence of Netherton's Syndrome, immunological deficiencies or diseases, organ transplant, HIV, diabetes, malignancy, malignant or pre-malignant skin conditions, serious active or recurrent infection, systemic immunosuppressive regimens, clinically significant severe renal insufficiency or severe hepatic disorders.
Use within one month before baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB therapy, 3) psoralen plus ultraviolet A therapy (PUVA), 4) tanning booths, 5) non-prescription ultraviolet (UV) light sources, 6) immunomodulators or immunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) tacrolimus or 10) pimecrolimus.
Use within 14 days before baseline of: 1) systemic antibiotics, 2) calcipotriene or other vitamin D preparations, or 3) retinoids.
Use within 7 days before baseline of: 1) antihistamines, 2) topical antibiotics, 3) topical corticosteroids or 4) other topical drug products.
Clareo Health | Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis
