Clinical Review

Halobetasol Propionate for the Management of Psoriasis

Author and Disclosure Information

The use of superpotent topical corticosteroids (TCSs) for the treatment of psoriasis is widely practiced, especially for expedient lesion resolution. However, their continued use in managing this chronic condition is limited because of labelling restrictions, concerns of side effects, and a paucity of data to support long-term management strategies. Halobetasol propionate (HP) is an effective short-term superpotent TCS. A novel HP lotion 0.01% formulation has been developed using a polymeric matrix technology that allows for uniform delivery of optimally sized particles onto the skin surface. The polymeric matrix and emulsion help to keep the skin hydrated and provide more efficient delivery of halobetasol into the epidermis.

Practice Points

  • The widespread use of superpotent topical corticosteroids in treating psoriasis is limited by labelling that restricts short-term use, concerns about side effects, and a paucity of clinical data with longer-term use.
  • Long-term management and treatment options are required for managing the chronic nature of psoriasis to improve patient satisfaction, adherence, and quality of life.
  • A novel formulation of halobetasol propionate lotion 0.01% has been developed using a polymerized matrix with active ingredients and moisturizing excipients suspended in oil droplets.


 

References

In clinical practice, for the majority of patients with psoriasis superpotent topical corticosteroids (TCSs) are used as initial therapy as well as ongoing breakthrough therapy to achieve quick resolution of target lesions. However, safe and effective long-term treatment and maintenance options are required for managing the chronic nature of psoriasis to improve patient satisfaction, adherence, and quality of life, especially given that package inserts advise no more than 2 to 4 weeks of continuous use to limit side effects. The long-term use of superpotent TCSs can have a multitude of unwanted cutaneous side effects, such as skin atrophy, telangiectases, striae, and allergic vehicle responses.1,2 Tachyphylaxis, a decreased response to treatment over time, has been more controversial and may not occur with halobetasol propionate (HP) ointment 0.05%.3 In addition, TCSs are associated with relapse or rebound on withdrawal, which can be problematic but are poorly characterized.

We review the clinical data on HP, a superpotent TCS, in the treatment of psoriasis. We also explore both recent formulation developments and fixed-combination approaches to providing optimal treatment.

Clinical Experience With HP 0.05% in Various Formulations

Halobetasol propionate is a superpotent TCS with extensive clinical experience in treating psoriasis spanning nearly 30 years.1,2,3-7 Most recently, a twice-daily HP lotion 0.05% formulation was evaluated in patients with moderate to severe disease.8 Halobetasol propionate lotion 0.05% applied morning and night was shown to be significantly more effective than vehicle after 2 weeks of treatment (P<.001) in 2 parallel-group studies of 443 patients.9 Treatment success (ie, at least a 2-grade improvement in investigator global assessment [IGA] and IGA score of clear or almost clear) was achieved in 44.5% of patients treated with HP lotion 0.05% compared to 6.3% and 7.1% in the 2 vehicle arms. Treatment-related adverse events (AEs) were uncommon, with application-site pain reported in 2 patients treated with HP lotion 0.05% compared to 5 patients treated with vehicle.9

Several earlier studies have evaluated the short-term efficacy of twice-daily HP cream 0.05% and HP ointment 0.05% in the treatment of plaque psoriasis, but only 2 placebo-controlled trials have been reported, and data are limited.

Two 2-week studies of twice-daily HP ointment 0.05% (paired-comparison and parallel-group designs) in 204 patients with moderate plaque psoriasis reported improvement in plaque elevation, erythema, and scaling compared to vehicle. Patient global responses and physician global evaluation favored HP ointment 0.05%, and reports of stinging and burning were similar with active treatment and vehicle.4

Similarly, HP cream 0.05% applied twice daily was shown to be significantly superior to vehicle in reducing overall disease severity, erythema, plaque elevation, and scaling after 1 and 2 weeks of treatment in a paired-comparison study of 110 patients (P=.0001).5 A clinically significant reduction (at least a 1-grade improvement) in erythema, plaque elevation, pruritus, and scaling was noted in 81% to 92% of patients (P=.0001). Patients’ self-assessment of effectiveness rated HP cream 0.05% as excellent, very good, or good in 69% of patients compared to 20% for vehicle. Treatment-related AEs were reported by 4 patients.5

A small, noncontrolled, 2-week pediatric study (N=11) demonstrated the efficacy of combined therapy with HP cream 0.05% every morning and HP ointment 0.05% every night due to the then-perceived preference for creams as being more pleasant to apply during the day and ointments being more efficacious. Reported side effects were relatively mild, with application-site burning being the most common.10

Potential local AEs associated with HP are similar to those seen with other superpotent TCSs. Overall, they were reported in 0% to 13% of patients. The most common AEs were burning, pruritus, erythema, hypopigmentation, dryness, and folliculitis.5-8,10-14 Isolated cases of moderate telangiectasia and mild atrophy also have been reported.8,10

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