Clinical safety evaluation of a novel barrier protection cream.
Patients with contact dermatitis require both preventive and therapeutic interventions to minimize their burden of disease. The ideal product would support resolution of inflamed skin without the use of glucocorticoids while protecting undamaged skin against further contact with irritants and antigens. COR806.805 (Tetrix Cream) is a novel barrier cream formulated for use on both lesional and nonlesional skin. Three clinical trials were conducted to evaluate the safety of this new product by studying sensitization, cumulative irritation, and effect on healing; a combined total of 265 participants completed the studies (210, 45, and 10, respectively), with no serious adverse events considered to be related to the product. Six mild adverse events were considered related or potentially related. As tested, COR806.805 is neither sensitizing nor irritating when applied to intact or lesional skin. Testing indicates that COR806.805 does not inhibit healing of allergic contact dermatitis lesions.
Slade
Herbert B
HB
DFB Pharmaceuticals, Inc, USA.
Fowler
Joseph
J
Reece
Barry T
BT
Cargill
D Innes
DI
D000328:Adult; D000485:Allergens; D000536:Aluminum Hydroxide; D002986:Clinical Trials as Topic; D003877:Dermatitis, Contact / Q000517:prevention & control*; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004643:Emollients / Q000627:therapeutic use*; D005260:Female; D006229:Hand Dermatoses / Q000517:prevention & control*; D006801:Humans; D008276:Magnesium Hydroxide; D012833:Siloxanes; D013228:Stearates
D000485:Allergens; D003879:Dermatologic Agents; D004643:Emollients; D012833:Siloxanes; D013228:Stearates; D000536:Aluminum Hydroxide; C487453:cyclomethicone; D008276:Magnesium Hydroxide