Safety assessment of topical formulation of nicotinamide gel (2%), (3%) and (4%) on skin of normal healthy New Zealand white Albino rabbits

Nicotinamide, a physiologically active form of niacin (nicotinic acid), in combination with zinc is being assessed in clinical studies for the treatment of inflammatory skin diseases such as acne vulgaris and bullous pemphigoid. Consequently the aim of the present study was to investigate the safety profile of Nicotinamide gel 2%, 3% and 4% (Apex Laboratories Private Limited, Chennai, India on skin of normal healthy New Zealand White Albino rabbits. The safety assessment was done for the single dose topical application of Nicotinamide 2%, 3% and 4% gel by the Draize skin test method in New Zealand White Albino rabbits. The topical application of Nicotinamide gel did not cause any erythema and edema in the skin of New Zealand White Albino rabbits like the control group. The primary irritation index was found to be zero which indicates the non-irritant nature of Nicotinamide 2%, 3% and 4% gel. Further, clinical evaluation has to be performed to precisely define the long term dermal safety of Nicotinamide gel 2%, 3% and 4% of human subjects.