Effectiveness and Patient Acceptance of Halcinonide 0.1% Cream in 216g Jars for Large-area Steroid-responsive Dermatoses

| April 14, 2011

Eric W. Baum, MD, MSc
University of Alabama at Birmingham, Birmingham, Alabama

Abstract
When treating patients with extensive dermatitis, total body surface area affected must be considered when prescribing topical medication. Halcinonide 0.1% cream, a class 2 topical corticosteroid, is now available in a 216g jar. This large size is convenient and cost effective for patients with large-area dermatoses. Objectives: The objectives of this study were to determine the efficacy and patient acceptance of halcinonide in 216g jars for the treatment of large-area dermatoses. Design: This study was an open-label, noncomparator trial evaluating the clinical outcomes and acceptability of halcinonide in 216g jars. Halcinonide was prescribed twice daily for up to 28 days. Measurement: Severity of dermatoses was based on investigator observations at the baseline visit and again after 28 days. Patient satisfaction was evaluated based on a questionnaire completed at the conclusion of the study. Results: Total enrollment was 40 patients. Dermatoses affected an average of 12 percent body surface area. At baseline, all patients exhibited dermatoses rated as severe or moderate. Nearly half of patients were completely cleared or almost cleared by 28 days, with all patients noting at least some improvement. Most patients agreed that they liked the way the product spread on the skin (94.7%), and more than 80 percent found that it was neither sticky nor greasy. In more than 90 percent of cases, the investigator reported that halcinonide provided a shorter duration of therapy versus triamcinolone one-pound jars. Conclusion: Halcinonide 0.1% cream in 216g jars is effective and convenient for patients with large-area dermatoses.
(J Clin Aesthet Dermatol. 2011;4(4):29–33.)

Evaluation of the affected skin area in dermatitis is a crucial factor in grading the degree of disease severity, as are location, number of lesions, response to topical therapies, and physical and psychological effects of the disease on the patient.[1] In the case of psoriasis, the percentage of body surface area (BSA) involved has traditionally been used to help determine severity. BSA involvement of three percent or less may be considered mild disease, involvement of 5 to 10 percent may be considered moderate disease, and involvement of greater than 10 percent may be considered severe disease.[2] Although patients may present with psoriasis in elbows, knees, palms, and soles, which are small surface areas in and of themselves, when added together, they may represent close to 10 percent BSA affected. Although the BSA may amount to less than 10 percent, hands and feet can cause significant disability. Further, anterior or posterior trunk represents 15 percent each for a total of 30 percent BSA. An entire leg (including the foot) represents roughly 20 percent of BSA.

When treating patients with extensive dermatitis, total BSA affected must be considered when prescribing topical medication. Small tubes of medication will not be sufficient to treat these patients for a typical four-week period. Insufficient medication may affect compliance and result in increased phone calls to the dermatology office and additional copays to obtain prescription refills. Patients with dermatitis affecting 10 percent BSA will require 165g of topical medication per month when applied twice daily, and those with 15 percent BSA affected will require nearly 250g per month when applied twice daily.[2]

Halcinonide is a class 2 topical corticosteroid indicated for relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatitis.[3] It is now available in a 216g jar, which provides convenience and cost effectiveness for patients with large-area dermatoses. It is an excellent choice for stepping up therapy from triamcinolone (class 4) or stepping down to maintenance therapy from super-potent topical corticosteroids. Compared with triamcinolone one-pound jars, halcinonide offers greater potency and one affordable copay for patients requiring treatment over a large surface area.

The present study was conducted to determine the efficacy and patient acceptance of halcinonide cream in 216g jars for the treatment of large-area corticosteroid-responsive dermatoses. Patients with large area (diffuse) dermatitis (BSA averaging 12%) were studied to ensure that the halcinonide cream in 216g jar was prescribed for patients who needed the entire jar contents over a period of one month or less.

Study Design
This study was designed as an open-label, noncomparator trial evaluating the clinical outcomes and acceptability of halcinonide 0.1% cream in 216g jars (Halog® Cream, Ranbaxy Laboratories, Princeton, New Jersey) based on investigator and patient assessments.

Goal for enrollment was at least 20 patients with a minimum age of 19 years who exhibited large-area dermatitis. Patients may or may not have been treated previously with triamcinolone one-pound jars and either relapsed or their condition was not resolved. Prior to study enrollment, patients agreed to the informed consent and the release and marketing authorization documents. Inclusion criteria included patients with steroid-responsive diffuse dermatitis of various etiologies. Conditions included psoriasis, hand eczema, nummular eczema, lupus erythematosus, contact dermatitis, and lichen simplex chronicus.

Halcinonide 0.1% cream in 216g jars was prescribed twice daily for up to 28 days. Patients applied the cream according to investigator instructions, which were within labeling. Severity of dermatoses was based on investigator observation at the baseline visit and again after 28 days. Severity was based on a rating scale of 0 to 5 (clear=0, almost clear=1, mild=2, moderate=3, severe=4, very severe=5). Photographs of the disease area were taken at baseline and at study completion. Patient satisfaction was evaluated through a questionnaire that was completed at the conclusion of the study.

Results
Patient demographics. Total enrollment in this study was 40 patients. Two patients did not return for their follow-up visits; therefore, end-of-study data are not available for these patients. Two-thirds of patients were men (65%) and 35 percent were women. Patient ages ranged from 23 to 85 years, with an average of 51.4 years. Eighty two and a half percent of patients were diagnosed with psoriasis; other diagnoses included irritant dermatitis, diffuse dermatitis, eczema, systemic lupus erythematosus, and allergic contact dermatitis.

Dermatoses affected 2 to 26 percent of patients’ BSA. Average area affected was 12 percent, requiring a considerable amount of topical corticosteroid within the study period of 28 days (Figure 1). Sixty percent of patients had used triamcinolone in one-pound jars previously. Greater efficacy of halcinonide versus triamcinolone was cited as the reason for prescribing halcinonide to study patients. None of the patients were on any systemic medications that would have affected their outcomes.

Severity of dermatoses. At baseline, all patients exhibited dermatoses rated as severe (70%) or moderate (30%) by the investigator (Figure 2a). Use of halcinonide 0.1% cream in 216g jars for 28 days decreased the severity of dermatoses in all patients by at least one score. Nearly half of patients (47.4%) were completely cleared or almost cleared by the end of the study, as assessed by the investigator (Figure 2b).

Evidence of clinical improvement in selected patients is presented in Figure 3a, Figure 3b, and Figure 3c. A 47-year-old Caucasian man with a 3.5-year history of psoriasis was diagnosed with psoriasis on his hands and feet, affecting five percent of his BSA. Past therapies included clobetasol propionate, desoximetasone, salicylic acid, acitretin, methotrexate, and ultraviolet A light (Figure 3a, Figure 3b, and Figure 3c). Severity of psoriasis at baseline was severe and improved to almost clear after 28 days of halcinonide 0.1% cream applied twice daily (Figure 3a). A 30-year-old Caucasian man was diagnosed with psoriasis affecting 22 percent of BSA and was treated with clobetasol propionate spray by his primary care physician. He had a four-month history of psoriasis, which at baseline was rated severe and improved to almost clear after 28 days of halcinonide 0.1% cream applied twice daily (Figure 3b). The third patient is a 30-year-old Caucasian woman who lost a leg to methicillin-resistant Staphylococcus aureus secondary to surgery for a ruptured Achilles tendon. She had a 14-year history of psoriasis, which had been treated with multiple topical corticosteroids, calcipotriene, and methotrexate. At baseline, she was diagnosed with severe psoriasis, affecting 15 percent of her BSA. After 28 days of treatment with halcinonide twice daily, psoriasis improved to almost clear/mild (Figure 3c).

Patient and physician acceptance. Upon completion of the study, patients were given a questionnaire that asked about their experience with halcinonide 0.1% cream in 216g jars, including improvement of condition, physical appearance, size of jar, application of the cream, and desire to reuse the product for future corticosteroid-responsive skin conditions. Nearly all patients noted at least some improvement in their skin with the use of the study medication, and most patients (94.7%, N=38) agreed that they liked the way the product spread on the skin. A majority of patients would request halcinonide 0.1% cream in 216g jars for future skin problems and stated that the product looked physically appealing (Figure 4)

Patients (n=25) who had prior experience with triamcinolone one-pound jars, found that halcinonide 0.1% cream in 216g jars required a shorter duration of therapy (30.4%), provided early relief of symptoms (60.9%), and was easier to apply (43.5%). The majority (60%) would use the halcinonide jar over the triamcinolone jar. According to the investigator’s observations, compared with triamcinolone one-pound jars, halcinonide 0.1% cream in 216g jars provided a shorter duration of therapy in 92.9 percent of cases, earlier relief in 39.3 percent of cases, and was easier to apply in 25 percent of cases. Since more than one answer was allowed for this question, percentages exceed 100 percent.

Discussion
Dermatosis, psoriasis in particular, is a skin condition that can affect a large BSA. Presence of psoriasis in the anterior or posterior torso alone can account for 15 percent of BSA. When treating patients with extensive psoriasis, the amount of medication required for treatment should be considered to prevent the patient’s supply from being depleted before the next office visit and to reduce the risk of poor compliance. Topical medications, such as halcinonide 0.1% cream in 216g jars, are manufactured with these considerations in mind.

The present study demonstrated that halcinonide 0.1% cream in 216g jars is effective in patients with psoriasis affecting an average of 12 percent BSA. Nearly half of patients were completely cleared or almost cleared of their skin condition after using halcinonide twice daily for 28 days. Baseline severity of disease was rated either moderate or severe. More than 8 out of 10 patients found halcinonide 0.1% cream in 216g jars highly favorable in terms of physical appearance, “spreadability,” and ability to improve skin conditions; nearly 9 out of 10 would use it for another skin condition in the future. In addition, patients agreed that the cream was neither sticky nor greasy—a common complaint of other topical corticosteroid creams and ointments.

Compared with triamcinolone in one-pound jars, halcinonide 0.1% cream in 216g jars required a shorter duration of therapy, provided earlier relief of symptoms, and was easier to apply.

References
1.    Tripodi S. Computer aided design mapping for SCORAD index in atopic dermatitis: ScoradCard software. Pediatr Allergy Immunol. 2005;16(2);182–183.
2.    Zeichner JA, Lebwohl MG, Menter A, et al. Optimizing topical therapies for treating psoriasis: a consensus conference. Cutis. 2010;86(Suppl 3):5–31.
3.    Halog® [package insert]. Princeton, NJ: Ranbaxy Laboratories, Inc; 2009.

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Category: Original Research, Past Articles

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