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

S. M. Satyam, K. L. Bairy, S. Musharraf, D. L. Fernandes

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)815-817
Number of pages3
JournalResearch Journal of Pharmaceutical, Biological and Chemical Sciences
Volume5
Issue number6
Publication statusPublished - 2014

Fingerprint

Niacinamide
Skin
Gels
Rabbits
Safety
Niacin
Bullous Pemphigoid
Acne Vulgaris
Erythema
Skin Tests
Skin Diseases
Zinc
India
Edema
Control Groups

All Science Journal Classification (ASJC) codes

  • Biochemistry, Genetics and Molecular Biology(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

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title = "Safety assessment of topical formulation of nicotinamide gel (2{\%}), (3{\%}) and (4{\%}) on skin of normal healthy New Zealand white Albino rabbits",
abstract = "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.",
author = "Satyam, {S. M.} and Bairy, {K. L.} and S. Musharraf and Fernandes, {D. L.}",
year = "2014",
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AU - Satyam, S. M.

AU - Bairy, K. L.

AU - Musharraf, S.

AU - Fernandes, D. L.

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

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