Tretinoin / Niacinamide Cream

Overview

Tretinoin / Niacinamide Cream is a combination of prescription drug products that have been formulated into a hypoallergenic cream to address acne vulgaris as well as rosacea. While mild cases of acne may respond well to over-the-counter treatments, stubborn cases require stronger treatments. Combining tretinoin and niacinamide into one formulation may increase patient compliance with treatment and improve both conditions. The preparation is applied to the affected area once to twice daily and the ingredients work synergistically together to decrease redness and pimples. Other benefits of the compound may include the reduction of fine lines and wrinkles and the lessening of hyperpigmentation.

Tretinoin

Tretinoin, also called all-trans-retinoic acid (ATRA), is a naturally occurring derivative of vitamin A (or retinol) that increases cell turnover. Tretinoin when applied topically is used to treat mild to moderate acne (e.g., grades I-III), photodamaged skin, and keratinization disorders such as ichthyosis and keratosis follicularis. Topical tretinoin is effective in reducing fine lines, hyperpigmentation, roughness, and laxity associated with photodamaged skin. It clears the skin of blemishes and discolorations by speeding the process of cell renewal.1, 2, 3, 4

 

Niacinamide

Niacinamide is the physiologically active form of niacin (vitamin B3). Found naturally in food (e.g., meat, dairy products, legumes, nuts, seeds, green leafy vegetables, fortified grains, etc.), niacinamide is a precursor of the cofactors niacinamide adenine dinucleotide (NAD) and niacinamide adenine dinucleotide phosphate (NADP). NAD and NADP are key components of many essential metabolic pathways in the human body. Niacinamide holds anti-inflammatory properties and is used topically to manage a variety of skin conditions including bullous pemphigoid, IgA bullous dermatosis, acne vulgaris, and pruritus (itching). Studies have also shown niacinamide’s ability to reduce redness and hyperpigmentation when applied topically.5, 6

Indications

Tretinoin is indicated for the topical treatment of inflammatory acne vulgaris.

How Supplied

At this time, this preparation is not commercially available in the United States as a single product and must be compounded for patients that would benefit from its administration as determined by a prescriber. Common formulations prepared at Galleria Medical Pharmacy include but are not limited to:

 Tretinoin 0.015% / Niacinamide 4% Cream

 Tretinoin 0.03% / Niacinamide 4% Cream

 Tretinoin 0.045% / Niacinamide 4% Cream

Storage

Store this medication at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.

Reference

  1. Altreno (tretinoin lotion) package insert; Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2018 Aug.
  2. Renova 0.02% (tretinoin cream) package insert; Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2013 Jun.
  3. Yoham AL, Casadesus D, “Tretinoin”. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557478/
  4. Fisher GJ, Wang Z, Datta SC, et al. Pathophysiology of premature skin aging induced by ultraviolet light. N Engl J Med 1997;337:1419-28.
  5. PC Chiu, CC Chan , HM Lin, HC Chiu, “The clinical anti-aging effects of topical kinetin and niacinamide in Asians: a randomized, double-blind, placebo-controlled, split-face comparative trial”, Journal of Cosmetic Dermatology vol.6, issue 4, pp. 243 -249, December 2007. Available: https://pubmed.ncbi.nlm.nih.gov/18047609/
  6. Forbat, F. Al-Niaimi, FR. Ali, “Use of nicotinamide in dermatology”, Clinical and Experimental Dermatology vol.42, issue 2, pp. 137 – 144, March 2017. Available: https://pubmed.ncbi.nlm.nih.gov/28052374/

 

Compounding Pharmacy Statement

This preparation is compounded with drug components whose suppliers are registered with the FDA. While Galleria Medical Pharmacy adheres to USP <795> guidelines and applicable state and federal regulations to meet the required quality standards, the statements made regarding this preparation have not been evaluated by the FDA for safety or clinical effectiveness. As such, this preparation is not intended to diagnose, treat, cure, or prevent any disease. For inquiries concerning this preparation, please contact (504) 267-9876.