Novel tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe acne vulgaris: assessment of safety and tolerability in subgroups.

Background: Topical tretinoin's role in acne has been established through evidence-based guidelines. Cutaneous irritation and potential to cause or exacerbate postinflammatory hyperpigmentation (PIH) may limit use.Objective: Evaluate safety and tolerability of novel polymeric formulation of tretinoin 0.05% lotion in moderate-to-severe acne.Methods: One thousand six hundred and forty patients randomized to tretinoin 0.05% lotion or vehicle in two double-blind placebo-controlled 12-week studies. Investigator-evaluated cutaneous safety (erythema and scaling) and patient-reported tolerability (itching, burning/stinging) assessed using a scale of 0 (none) to 3 (severe). Hyper- and hypo-pigmentation evaluated at each study visit. A number of subpopulations were investigated.Results: Tretinoin 0.05% lotion was considered safe and very well tolerated. Only application site pain (3.1%), dryness (3.7%) and erythema (1.4%) were reported by >1% or patients. Treatment-related adverse events were particularly rare (≤2%) in Hispanic and male subpopulations, and lower in adult females. The severity of cutaneous safety and tolerability scores remained <0.5 (where 1 = mild) and were generally lower than baseline severity. Tretinoin 0.05% lotion did not appear to cause or exacerbate PIH.Conclusions: A novel polymeric formulation of tretinoin 0.05% lotion provides a highly favorable safety and tolerability profile, with an incidence of erythema, dryness, and skin burning lower than that previously reported with other formulations of tretinoin.

Evaluating and treating the adult female patient with acne.

Acne vulgaris is a common disease of the pilosebacous unit that affects an estimated 40-50 million Americans. Greater than 95% of teenage boys and between 83% and 85% of teenage girls suffer from acne. The condition frequently continues into adulthood. While boys more commonly suffer from acne in the teenage years, greater numbers of women suffer into adulthood. It is unclear if the number of post-adolescent women with acne is rising as compared to the past, or whether women are now seeking out treatment more than in the past.(4) Post-adolescent acne is a significant problem for women. One survey-based United States study found that approximately 50% of women continue to suffer from acne in their twenties, 35% in their thirties, 26% in their forties, and 15% in their fifties. The prevalence of acne was shown to be higher in women than in men in each of these age groups.(7) A similar study from Europe showed that beyond the age of 23, acne is more prevalent in women than men. In their forties and fifties, 5% and 8% of women suffered from acne, respectively. Several other studies have provided similar data, showing that larger numbers of adult women suffer from acne as compared to age matched men. Acne is the number one reason that patients visit a dermatologist. While the mean age at which patients are seen for acne is 24 years old, 10% of visits occur in patients in their mid-thirties and forties. Approximately two thirds of dermatology visits for acne are made by women, and one-third of total acne office visits are made by women over 25 years old. Acne patients suffer from a significant psychological burden, which has been compared to that of patients with systemic diseases like diabetes, asthma, arthritis, or epilepsy. Up to 50% of adolescents with acne experience disturbances to their psyche, including issues with body image, anxiety, depression, poor self-esteem, social impairment, and thoughts of suicide. Moreover, acne treatment is expensive. The average total cost of care related to an acne patient's visit to the dermatologist is estimated to be $689.(14)

The role of the human papillomavirus (HPV) vaccine in developing countries.

Cervical cancer is a preventable health problem, yet is the second most common cancer of women worldwide. More than 80% of cases occur in developing countries, and this is expected to increase to 90% by the year 2020. The five-year survival rate of patients in developing countries is less than 50%, compared to 66% in developed nations. A worldwide HPV vaccine program would significantly reduce the spread of HPV 16 and 18 and lower the incidence of cervical cancer. Mathematical models have determined that vaccinating 66% of the population will decrease the incidence of cervical cancer by 80% over the next 40-60 years. For every five-year delay in a cervical cancer prevention/detection program, there will be an additional 1.5-2.0 million deaths. The introduction of a vaccination program will be a challenge due to high costs, unknown durability of the vaccine, and the potential for new oncogenic strains to emerge. A global effort will be required to eliminate cervical cancer from developing counties.