A randomized trial of the efficacy of a new micronized formulation versus a standard formulation of isotretinoin in patients with severe recalcitrant nodular acne.

BACKGROUND: Isotretinoin is very frequently the drug of choice for the management of severe recalcitrant nodular acne. Recently, a new micronized and more bioavailable formulation of isotretinoin has been developed that permits once-daily administration in lower doses than usually used with standard isotretinoin (Accutane), regardless of whether it is taken with or without food. OBJECTIVE: Our purpose was to determine whether micronized isotretinoin and standard isotretinoin are clinically equivalent. METHODS: In this multicenter, double-blind, double-dummy study, 600 patients with severe recalcitrant nodular acne were treated with either 0.4 mg/kg of micronized isotretinoin once daily without food (n = 300) or 1.0 mg/kg per day of standard isotretinoin in two divided doses with food (n = 300). Lesion counts were monitored over 20 weeks. RESULTS: Both treatment groups in this well-controlled clinical trial experienced an equivalent reduction in the number of total nodules (facial plus truncal). In addition, an equivalent proportion of patients achieved 90% clearance of the total number of nodules. Both formulations had similar results for other efficacy variables. CONCLUSION: Once-daily use of the micronized and more bioavailable formulation of isotretinoin under fasted conditions is clinically equivalent to the standard twice-daily formulation under fed conditions in the treatment of severe recalcitrant nodular acne.

Safety of a new micronized formulation of isotretinoin in patients with severe recalcitrant nodular acne: A randomized trial comparing micronized isotretinoin with standard isotretinoin.

BACKGROUND: Isotretinoin is a very effective drug for treating severe recalcitrant nodular acne. A new micronized formulation of isotretinoin has been shown to be clinically equivalent to standard isotretinoin with improved bioavailability and minimal food effect. The safety profile of the micronized formulation has not been described previously. OBJECTIVE: The objective of this article is to report the incidence and intensity of adverse events found in a comparative, double-blind efficacy study that showed clinical equivalence of the new micronized formulation of isotretinoin and the standard isotretinoin formulation (Accutane). METHODS: Six hundred patients with severe recalcitrant nodular acne were treated with micronized isotretinoin (n = 300) under fasted conditions or standard isotretinoin (n = 300) under fed conditions. One cohort received single daily doses of 0.4 mg/kg of micronized isotretinoin without food and the other cohort received 1.0 mg/kg per day of standard isotretinoin in two divided doses with food. Adverse events were monitored during 20 weeks of drug therapy. RESULTS: The proportion of adverse events in most body systems was generally lower in patients receiving micronized isotretinoin than in those receiving standard isotretinoin. CONCLUSION: Micronized isotretinoin appears to have a safety profile similar to that of standard isotretinoin and to carry a lower risk of mucocutaneous events and hypertriglyceridemia.

"Be smart, be safe, be sure". The revised Pregnancy Prevention Program for women on isotretinoin.

OBJECTIVES: After studying the information in this article, the reader should be able to: 1. Describe the purpose of the pregnancy prevention program. 2. Discuss the five most common reasons for unintended pregnancy. 3. List the components of the expanded pregnancy prevention program. Preventing unintended pregnancy is currently an unsolved problem in the United States, especially among teens. However, successful programs to minimize unintended pregnancy do exist and can serve as a model for other efforts. One such program is the Pregnancy Prevention Program, for use when prescribing isotretinoin to women with childbearing potential. Isotretinoin is a known teratogen and is prescribed disproportionately to teens, who are at higher risk of unintended pregnancy. The program has shown impressive effectiveness despite these handicaps, but since exposure to isotretinoin is so harmful to the fetus and some women still become pregnant while taking the drug, the program has been revised to reduce the failure rate further.

Concomitant administration of vitamin E does not change the side effects of isotretinoin as used in acne vulgaris: a randomized trial.

BACKGROUND: Isotretinoin treatment is frequently associated with reversible, dose-related side effects. Recent studies claimed that combining vitamin E with high-dose isotretinoin ameliorated isotretinoin-induced side effects. OBJECTIVE: The purpose of this double-blind, randomized study was to determine the effects of a fixed dose of vitamin E on the side effects of isotretinoin for treatment-resistant acne vulgaris. METHODS: One hundred forty subjects were randomly assigned to one of two treatment programs with isotretinoin (1 mg/kg) together with either vitamin E (800 IU/day) or a vitamin E placebo for 20 weeks. The incidence, severity, and duration of the side effects (eg, dry eyes, dry lips) were assessed. RESULTS: A fixed 800 IU/day dose of vitamin E did not improve the incidence, severity, or duration of side effects associated with isotretinoin (1 mg/kg per day). CONCLUSION: Vitamin E did not significantly ameliorate retinoid side effects when combined with 1 mg/kg of isotretinoin in the treatment of acne.

Acitretin in psoriasis: an overview of adverse effects.

Oral retinoids are among the drugs of choice for pustular and erythrodermic psoriasis. In addition, retinoids are effective in combination with other topical and systemic agents for the treatment of plaque-type psoriasis. Acitretin, the active retinoid metabolite, has replaced etretinate in retinoid therapy of psoriasis because of its more favorable pharmacokinetic profile, including a significantly shorter half-life. Retinoids, including acitretin, are potent teratogens, leading to strict requirements for pregnancy prevention during and after their use. Other retinoid side effects are generally preventable or manageable through proper patient selection, dose adjustments, and routine monitoring. Mucocutaneous side effects such as cheilitis and hair loss are the most common dose-dependent side effects, requiring dose reduction in some patients. Less common effects such as hepatotoxicity, serum lipid alterations, pancreatitis, and possible skeletal effects are also discussed.

UVB therapy: dermatology nursing considerations.

Each patient responds uniquely to phototherapy treatment. Not every patient can tolerate daily treatment. Different areas of the body require different amounts of light in order to clear. Precise documentation of erythema is important for both treatment and legal reasons. A negative response to UVB therapy can be from either ineffective treatment or an adverse reaction to UVB.

Psoralen photochemotherapy.

Psoralens and sunlight have been used by the Egyptians and Indians for hundreds of years for treating vitiligo. The combination of oral psoralens and artificial ultraviolet A (PUVA) therapy was approved for managing severe psoriasis by the Food and Drug Administration in 1982. Since then, PUVA therapy has been an effective modality for treating many cutaneous conditions (psoriasis, atopic dermatitis, vitiligo, and mycosis fungoides). However, proper knowledge and administration of PUVA therapy are vital to treatment success and reducing side effects.

Staff responsibilities for phototherapy administration.

Caring for the phototherapy patient is a multifaceted role; however, the primary nursing responsibility is quality patient education. The opportunities to implement this responsibility are as endless as the disease itself.

Phototherapy equipment.

Treating patients with phototherapy is like dosing patients with medication. The purpose of this continuing education article is to describe various phototherapy equipment and how to conduct safe and efficacious therapy.

Basic principles of photobiology and photochemistry for nurse phototherapists and phototechnicians.

Phototherapy administration requires a team approach to be safe and effective. Implementing the treatment plan requires the knowledge, skills, and expertise of the entire health care team. Understanding the relationship between natural light, artificial light sources, administration of phototherapy, and the short and long-term consequences of the therapy can enhance the experience for the patient and provide an increase in employment satisfaction for the therapist.

Nurses' guide to the drug development process and the current regulatory environment.

Health care professionals are frequently asked to answer patients' questions about how medications reach the market and the lengthiness of the process. Misconceptions about the process require nurses to understand how the Food and Drug Administration (FDA) enforces its laws, and how the agency works in the enforcement of its responsibilities. The purpose of this article is to familiarize nurses' with the FDA's history and the drug development process. In addition, nurses need to be familiar with the current environment at the agency and issues that are currently under debate (Franke, 1992).

Acne: therapeutic perspectives with an emphasis on the role of isotretinoin.

This article provides nurses with information about drug therapy for acne. Various therapeutic modalities are discussed with an emphasis on the use of isotretinoin. The risks associated with pregnancy during isotretinoin therapy are discussed to help nurses work effectively with physicians and patients in the treatment of severe acne in women of childbearing potential.

Potential hazards in phototherapy with ultraviolet radiation arising from variation in dose required to produce erythema.

Phototherapy using 290-320 nm ultraviolet radiation (ultraviolet B) is an effective form of treatment for several skin diseases and is especially useful for psoriasis. Technical advances have made it more economical and convenient to quantify ultraviolet radiation. Ten volunteers received a series of exposures from three ultraviolet B sources to illustrate how variation in the spectral properties of phototherapy devices can lead to unanticipated and potentially severe sunburn reactions. The corresponding minimal erythema dose was then calculated with the use of irradiance data measured with two commercially available photometers. Variation in minimal erythema dose among the three sources tested indicates the need to characterize the emission spectrum of sources and the spectral sensitivity of the photometer used to measure its output.

Quinidine photosensitivity.

A 55-year-old woman developed a dermatitis confined to light-exposed areas while taking quinidine gluconate, warfarin sodium, furosemide, spironolactone, and digoxin after cardiac surgery. Phototesting indicated a normal erythematous response to 290- to 320-nm ultraviolet radiation, but she developed erythema from 6 joules/sq cm of 320- to 400-nm radiation (ultraviolet A [UV-A]), a much lower dose than needed to produce a reaction in normal individuals. Two days after she discontinued quinidine and warfarin, phototesting showed no reaction to as much as 20 joules/sq cm of UV-A. One week after resuming quinidine (but not warfarin), she again reacted to 8 joules/sq cm of UV-A. No reactivity was elicited when the preparation was applied to the skin or injected into the dermis either with or without subsequent UV-A irradiation.

Modified Goeckerman therapy for psoriasis. A two-year follow-up of a combined hospital-ambulatory care program.

Two groups totaling 162 patients hospitalized for modified Goeckerman treatment of severe psoriasis were matched for sex, age, and season of admission and followed up for two years after discharge. One group remained hospitalized throughout their average 20.8-day course; the other half was hospitalized 14 days, then transferred to an ambulatory center for the remainder of a course averaging 20.8 days. No difference was detected between the groups in the duration that improvement equaled or exceeded progress achieved at discharge. The percentage of patients remaining continuously improved after discharge was 80% at one month, 55% at six months, 40% at 12 months, and 20% at 24 months. rates of relapse requiring readmission or alternate therapy were also similar: 75% had not relapsed by 12 months and 60% had not relapsed by 24 months.