Inflammatory Acne Management With a Novel Prescription Dietary Supplement
December 2012 | Volume 11 | Issue 12 | Original Article | 1428 | Copyright © December 2012
Alan R. Shalita MD,a Ronald Falcon MD,b Alan Olansky MD,c Patricia Iannotta MD,d Arash Akhavan MD,e Doris Day MD,f, Anthony Janiga MD,g Prashant Singri MD,h and John E. Kallal PhDi
aDepartment of Dermatology, SUNY Downstate Medical Center, Brooklyn, NY bLong Beach Medical Center, Long Beach, NY cEmory University Hospital, Atlanta, GA dRobert Wood Johnson University Hospital, New Brunswick, NJ eMount Sinai Medical Center, New York, NY fNew York University Medical Center, New York, NY gAdvanced Clinical & Surgical Dermatology, Naperville, IL hNorthwestern University, Feinberg School of Medicine, Dermatology Department, Chicago, IL iElorac Inc, Vernon Hills, IL
Abstract
Background: Inflammatory acne, particularly in postadolescent women, is increasing in incidence. The most effective therapeutic modality
for treatment of this type of acne has been the administration of oral tetracyclines. Long-term acne treatment with such drugs,
however, is frequently accompanied by undesirable adverse reactions, including gastrointestinal disturbances, antianabolic effects,
headaches, tinnitus, and photosensitivity.
Objective: To assess the usefulness of a novel dietary supplement in the overall management of patients with inflammatory acne vulgaris.
Methods: 235 patients with inflammatory acne vulgaris were enrolled by dermatologists in a multicenter, open-label, 8-week, prospective
study evaluating the effects of adding NicAzel, 1 to 4 tablets daily, to their current acne treatment regimen.
Results: A statistically significant (P<.0001) number of patients demonstrated improvement over their previous acne treatment regimens
after both 4 and 8 weeks of NicAzel (nicotinamide, azelaic acid, zinc, pyridoxine, copper, folic acid; Elorac Inc, Vernon Hills, IL) use.
At week 8, 88% of the patients experienced a visible reduction in inflammatory lesions, and 81% of the patients rated their appearance
as much or moderately better compared with baseline. Three-quarters (76%) of the patients thought NicAzel was at least as effective
as previous treatment with oral antibiotics.
Conclusion: Patients with inflammatory acne showed significant improvement in acne severity and overall appearance when NicAzel was
added to their existing treatment regimen.
J Drugs Dermatol. 2012;11(12):1428-1433.
INTRODUCTION
Acne vulgaris is a chronic, inflammatory disease of the
pilosebaceous unit that affects approximately 50 million
individuals each year in the United States. The
pathophysiology of acne is associated with multiple, complex
interactive causative influences, including genetic predisposition.
The initial process in the formation of acne begins in
the upper portion of the follicle of the pilosebaceous unit and
progresses with hyperkeratosis of the follicle lining, increased
cohesiveness of corneocytes, and accumulation of keratin and
sebum. As the trapped comedo materials expand, the tension
on the follicular wall increases, resulting in their rupture and
extrusion of the immunogenic keratin and sebum with resultant
inflammation. The inflammatory lesions of acne, which
originate with comedo formation, expand to form erythematous
papules, pustules, nodules, and cysts, and depending on
severity, may result in scarring.
Four factors are involved in the etiology of acne: 1) excessive production
of sebum, likely due to androgenic factors; 2) bacterial
colonization and release of inflammatory mediators; 3) inflammation;
and 4) abnormal keratinization within the follicle. Sebaceous
follicles are usually colonized with gram-positive, lipase-producing
Propionibacterium acnes within inflammatory lesions or
open and closed comedones. The presence of P acnes or other
bacteria in the sebaceous follicles stimulates the production of
proinflammatory cytokines/chemokines via the activation of tolllike
receptors on the membranes of inflammatory cells. The role
of P acnes is complex, and there is still some uncertainty about
its effects on acne—whether through direct microbial action or
through stimulation of inflammatory processes in the skin.1 Other
inflammatory lesions of acne include nodules, papules, pustules,
and cysts, which may lead to lifelong sequelae, including scarring,
hyperpigmentation changes, and emotional distress.2
