Halobetasol Propionate Ointment Research Articles

Striae atrophicans: A mimic to Cushing′s cutaneous striae

Sir, A 30-year-old male patient was referred for evaluation of Cushing's syndrome when he presented with purple striae over both the thighs [Figure 1] for 1 month. He did not have any systemic symptoms. There was no history of any drug intake including oral or parenteral steroids. He was applying steroid ointment (halobetasol propionate 0.05%) for fungal infection locally for 3 months prior to this. These striae were violaceous, with the largest one measuring 10 cm in length and 1.8 cm in width, which is classical for Cushing's syndrome. His body mass index was 26.0 kg/m2. He did not have any systemic effects of steroid, though human and animal studies indicate that less than 6% of the applied dose of halobetasol propionate enters the circulation within 96 hours following topical administration of the cream.[1] His morning and evening cortisol levels were 10.65 μg/dL and 5.28 μg/dL, respectively. Overnight dexamethasone test revealed suppressible serum cortisol (0.55 μg/dL). Halobetasol propionate cream produced hypothalamic-pituitary-adrenal (HPA) axis suppression when used in divided doses at 7 g/day for 1 week.[2] His serum cortisol level following adrenocorticotropic hormone (ACTH) stimulation test was 25.6 μg/dL. He was diagnosed as a case of striae atrophicans, which is a known complication of chronic application of topical steroid preparations. Halobetasol is grouped under ultra high potency topical steroid and has more propensity to cause side effects. The glucocorticoids affect the epidermis by preventing the fibroblasts from forming collagen and elastin fibers, necessary to keep the rapidly growing skin taut. This creates a lack of supportive material, as the skin is stretched and leads to dermal and epidermal tearing.[3] Topical application of steroids is known to cause systemic effects of hypercortisolism and suppression of HPA axis, but this is very rarely manifested clinically and is easily reversible. This patient has neither any systemic manifestation nor any evidence of adrenal suppression. Figure 1 Multiple cutaneous striae at thigh

A randomized, double-blind, placebo-controlled study to evaluate the efficacy of ammonium lactate lotion 12% and halobetasol propionate ointment 0.05% in the treatment and maintenance of psoriasis

A randomized, double-blind, placebo-controlled study to evaluate the efficacy of ammonium lactate lotion 12% and halobetasol propionate ointment 0.05% in the treatment and maintenance of psoriasis

Compatibility of Ammonium Lactate 12% with Halobetasol Propionate 0.05% and Hydrocortisone Valerate 0.2%

Background Topical corticosteroids are the most common agents used to treat psoriasis in the United States but are associated with a number of side effects including cutaneous atrophy. Ammonium lactate is proven to prevent cutaneous atrophy by preserving dermal ground substance and reducing steroid-induced epidermal atrophy. Objective To determine the compatibility of ammonium lactate with halobetasol propionate and hydrocortisone valerate when mixed together. Methods 0.05% halobetasol propionate ointment and 0.2% hydrocortisone valerate ointment were mixed with 12% buffered ammonium lactate lotion and analyzed at regular time intervals for evidence of degradation via high-pressure liquid chromatography. Results No significant degradation of either halobetasol propionate or hydrocortisone valerate was observed after mixing with ammonium lactate 12%. Conclusion It is possible to treat psoriasis with the simultaneous application of either halobetasol propionate ointment or hydrocortisone valerate ointment, and ammonium lactate 12% lotion. Limitations Clinical correlation should be performed examining the concomitant application of halobetasol propionate or hydrocortisone valerate, and ammonium lactate 12%.

Successful Treatment of Long‐Standing, Recalcitrant Subcorneal Pustular Dermatosis With Etanercept

Successful Treatment of Long‐Standing, Recalcitrant Subcorneal Pustular Dermatosis With Etanercept

Topical Halobetasol Propionate in the Treatment of Plaque Psoriasis

Halobetasol propionate (HP) 0.5% ointment and cream are class I topical corticosteroids. We review the efficacy and tolerability of HP for treatment of plaque psoriasis in the English language literature. The efficacy of HP ointment and cream is consistently superior to other super-potent topical corticosteroids. Local adverse events associated with topical HP are similar to those experienced with other super-potent corticosteroids. Combination therapy with calcipotriene (calcipotriol) and tazarotene appears to be superior to monotherapy with topical HP.

A multicenter trial of calcipotriene ointment and halobetasol ointment compared with either agent alone for the treatment of psoriasis

Calcipotriene, a vitamin D3 analogue, inhibits cell proliferation and induces cell differentiation in vitro. 1, 2 Many studies have shown that calcipotriene ointment (0.005%) is effective in the treatment of plaque psoriasis. 3, 4 The purpose of this three-axrn trial was to evaluate the efficacy and safety of calcipotriene ointment 0.005% applied in the morning and halobetasol propionate 0.05% ointment applied in the evening versus calcipotriene ointment applied twice daily versus halobetasol propionate ointment applied twice daily for moderate plaque psoriasis.

A double-blind, multicenter, parallel-group trial with 0.05% halobetasol propionate ointment versus 0.1 % diflucortolone valerate ointment in patients with severe, chronic atopic dermatitis or lichen simplex chronicus

In a double-blind, parallel-group, multicenter, comparative trial in 120 evaluable patients with chronic, localized atopic dermatitis or lichen simplex chronicus, the success rate (described as "healed" and "marked improvement") was 91.5% in patients treated with halobetasol propionate ointment and 83.6% in those in the diflucortolone valerate treatment group. Of patients treated with halobetasol propionate ointment, 40.7% reported healing within 17 days, whereas of those in the diflucortolone valerate treatment group, 32.8% reported healing within that time. Early onset of therapeutic effect, that is, within 3 days of the start of treatment, was reported in a higher percentage of patients treated with halobetasol propionate ointment than in those treated with diflucortolone valerate ointment (70% versus 59%). Adverse effects at the site of application were less frequently reported in patients belonging to the halobetasol propionate treatment group than in those treated with diflucortolone valerate ointment (3% versus 8%).

A double-blind, multicenter trial of 0.05% halobetasol propionate ointment and 0.05% clobetasol 17-propionate ointment in the treatment of patients with chronic, localized atopic dermatitis or lichen simplex chronicus

In a double-blind, parallel-group, multicenter comparative trial in 127 evaluable patients with chronic, localized atopic dermatitis or lichen simplex chronicus, healing was reported in a higher percentage of patients treated with halobetasol propionate ointment than in those in the clobetasol propionate treatment group (65.1% versus 54.7%). The success rates (described as "healed" and "marked improvement") were practically identical in the two treatment groups (93.7% versus 92.2%). Early onset of therapeutic effect, that is, within 3 days of the start of treatment, was similar in the two treatment groups (24% versus 28%). Both preparations were well tolerated. Adverse effects were reported in 5% and 2% of the patients treated with halobetasol propionate and clobetasol propionate ointments, respectively.

A double-blind, multicenter comparison of 0.05% halobetasol propionate ointment and 0.05% clobetasol propionate ointment in patients with chronic, localized plaque psoriasis

In a double-blind, parallel-group, multicenter trial in 134 patients with severe, localized, plaque psoriasis, the success rate (described as "healed" or "marked improvement") at the end of the study was 96% in the halobetasol propionate group and 91% in the clobetasol propionate group. A significantly larger proportion of patients treated with halobetasol had no disease or mild disease after 14 days compared with those treated with clobetasol (86% versus 70%, p = 0.023). Healing within 24 days of starting treatment was noted in 69% and 56% of patients treated with halobetasol and clobetasol, respectively. Adverse effects were reported in a smaller percentage of patients treated with halobetasol propionate ointment than in those treated with clobetasol propionate ointment (7% versus 12%). Cosmetic acceptability and ease of application were recorded as "very good" in a larger percentage of patients treated with halobetasol propionate ointment than in the group treated with clobetasol propionate (90% versus 80%).

Double-blind bilateral paired comparison of 0.05% halobetasol propionate cream and its vehicle in patients with chronic atopic dermatitis and other eczematous dermatoses

Six investigators evaluated 0.05% halobetasol propionate cream and its vehicle in 111 patients with chronic atopic dermatitis and several other eczematous dermatoses. Patients applied treatment twice daily to bilateral lesions for 14 days. Investigators graded pruritus, erythema, scaling, papulation, and lichenification using 4-point severity scales on days 0, 7, and 14. On day 14 patients provided an assessment of efficacy for both treatments. Statistically significant differences favoring halobetasol propionate over the vehicle were seen for all signs and symptoms (p less than 0.001). Substantial improvements were achieved by the active treatment by day 7 (p less than 0.001). Patients assessments of efficacy were significantly higher for halobetasol cream than for vehicle (p less than 0.001). No instances of systemic effects or skin atrophy were reported and adverse experiences were limited to burning or stinging and other minor, nonspecific complaints distributed uniformly between active treatment and vehicle. These results demonstrate that 0.05% halobetasol propionate cream is highly effective in the treatment of atopic dermatitis and other eczematous dermatoses.

Double-blind, comparative clinical trials with halobetasol propionate cream in patients with atopic dermatitis

In two double-blind, parallel-group, multicenter trials, 0.05% halobetasol propionate cream was compared with 0.05% clobetasol 17-propionate cream and 0.05% betamethasone dipropionate cream in 264 patients with acute, severe exacerbations of atopic dermatitis. The efficacy of halobetasol propionate cream and betamethasone dipropionate cream was similar with regard to the success rate, as indicated by ratings of "healed" and "marked improvement" (88% versus 90%) and by an onset of therapeutic effect within 3 days of the start of treatment (40% versus 39%). The efficacy of halobetasol propionate cream and clobetasol 17-propionate cream was also similar with regard to success rates (89% versus 93%) and an onset of therapeutic effect within 3 days of the start of treatment (41% versus 38%). All three creams were well tolerated. Dryness of the skin and itching at the site of application were the reported adverse effects. Treatment was discontinued because of severe dryness of the skin in 1 of the 121 patients treated with halobetasol propionate cream and in 1 of the 59 patients treated with betamethasone dipropionate cream.

Halobetasol propionate cream by day and halobetasol propionate ointment at night for the treatment of pediatric patients with chronic, localized plaque psoriasis and atopic dermatitis

In a multicenter, 14-day pediatric study in 81 evaluable patients with severe, localized corticosteroid-susceptible dermatoses, the combined treatment with halobetasol propionate cream once during the day and halobetasol propionate ointment once at night produced a very satisfactory therapeutic effect. The success rates, as indicated by ratings of "healed" and "marked improvement," were 100% and 90.9% in patients with atopic dermatitis and psoriasis vulgaris, respectively. Healing was reported in 86.8% and 72.7% of patients treated for atopic dermatitis and psoriasis, respectively. Both the cream and ointment preparations were well tolerated. Adverse effects at the site of application were reported in only 3 of 81 patients. Mild skin atrophy was observed in one patient. No systemic adverse effects were observed.

A double-blind, multicenter comparison between 0.05% halobetasol propionate ointment and 0.05% betamethasone dipropionate ointment in chronic plaque psoriasis

In a double-blind, parallel-group, multicenter comparative trial on 104 evaluable patients with severe, localized plaque psoriasis, 0.05% halobetasol propionate ointment demonstrated an 88.7% success rate assessed as "healed" or "marked improvement" compared with 78.5% for 0.05% betamethasone dipropionate ointment. Healing was observed within 24 days of the start of treatment in 40% and 25% of the patients who received halobetasol propionate and betamethasone dipropionate ointments, respectively. After 4 weeks' treatment, tolerability of both ointments was good. Neither skin atrophy nor systemic adverse effects were observed. Patient acceptance of halobetasol propionate ointment, based on cosmetic acceptability and ease of application, was significantly better (p = 0.02) than that of betamethasone dipropionate ointment.

A review of two controlled multicenter trials comparing 0.05% halobetasol propionate ointment to its vehicle in the treatment of chronic eczematous dermatoses

The efficacy and safety of 0.05% halobetasol propionate ointment were evaluated in patients with chronic atopic or other eczematous dermatoses in two vehicle-controlled, double-blind studies: a paired-comparison study in 124 patients (study A) and a parallel-group study in 100 patients (study B). In study A, patients applied both treatments twice daily for 2 weeks and were evaluated by investigators on days 0, 7, and 14 with 0 to 3 severity scales and by self-assessment with two 5-step end-of-treatment rating scales. In study B, patients applied treatments twice daily for 2 weeks, and investigators made evaluations on days 0, 3, 7, and 14 with 0 to 6 scales and also made a 5-step end-of-treatment physician's global assessment. In study A, both severity scores and patient ratings favored halobetasol propionate significantly on days 7 (p less than or equal to 0.0013) and 14 (p less than 0.0001); in study B, severity scores on days 3 (p less than or equal to 0.045, pruritus, erythema, and overall lesion severity), 7, and 14 (p less than 0.001, all comparisons) also favored halobetasol propionate significantly, and global assessments showed complete resolution or marked improvement for 83% of patients using halobetasol propionate versus 28% of those using vehicle (p less than 0.0001). No instances of systemic effects or skin atrophy were reported in either study. We conclude that 0.05% halobetasol propionate ointment is highly effective and well tolerated in the treatment of the conditions studied, with the rapid action and high degree of clearing associated with superpotent corticosteroid formulations.

Dermatopharmacologic investigations of halobetasol propionate in comparison with clobetasol 17-propionate

Both halobetasol propionate and clobetasol 17-propionate exerted very marked antiinflammatory, antiproliferative, and vasoconstrictive effects during evaluation in a range of dermatopharmacologic models. Halobetasol propionate was distinctly more potent than clobetasol 17-propionate in the ultraviolet-induced dermatitis inhibition assay in guinea pigs and in the rat model of oxazolone-induced late inflammatory reaction. Halobetasol propionate was slightly more potent than clobetasol 17-propionate in inhibiting croton oil-induced ear edema in rats and mice and in the mouse model of oxazolone-induced early inflammatory reaction. In the cotton-pellet granuloma assay in rats and the epidermal hyperplasia inhibition assay in guinea pigs, halobetasol propionate was distinctly superior to clobetasol 17-propionate. There was a trend in favor of halobetasol propionate in the cutaneous vasoconstriction assay performed in volunteers with ethanol solutions of halobetasol propionate and clobetasol 17-propionate. In a further vasoconstriction assay, performed with a 0.05% concentration of both halobetasol propionate and clobetasol 17-propionate in cream and ointment formulations, halobetasol propionate ointment yielded the highest blanching score. In a hypothalamic-pituitary-adrenal axis study in volunteers, effects of 0.05% halobetasol propionate ointment and 0.05% clobetasol 17-propionate ointment on serum cortisol levels were similar. The overall efficacy trends demonstrated in these dermatopharmacologic studies are in agreement with predictions made from corticosteroid structure and activity relationships and the results of two clinical trials comparing halobetasol propionate and clobetasol 17-propionate ointments in the treatment of plaque psoriasis.

A comparative, multicenter, double blind trial of 0.05% halobetasol propionate ointment and 0.1 betamethasone valerate ointment in the treatment of patients with chronic, localized plaque psoriasis

In a double-blind, parallel-group, multicenter comparative trial in 84 evaluable patients with severe, localized plaque psoriasis, 0.05% halobetasol propionate ointment proved significantly superior (p = 0.02) to 0.1% betamethasone valerate ointment with respect to the success rate, as indicated by ratings of "healed" or "marked improvement" (88.1% versus 64.3%). The therapeutic effect was observed within 5 days of the start of treatment in 76% and 67% of the patients treated with halobetasol propionate and betamethasone valerate ointments, respectively. Both preparations were well tolerated. Minor adverse effects at the site of application were reported in only 2% of the patients in each treatment group. Neither skin atrophy nor systemic adverse effects were observed.

Evaluation of halobetasol propionate ointment in the treatment of plaque psoriasis: Report on two double-blind, vehicle-controlled studies

The results of two studies are presented that reveal the efficacy and safety of 0.05% halobetasol ointment in the treatment of patients with plaque psoriasis of at least moderate severity. Both multicenter studies were randomized, double-blind, and vehicle controlled, and study medications were applied twice daily for 2 weeks. One study was a paired-comparison (PC); the other study was of parallel-group (PG) design. Both studies called for evaluations at entry (week 0) and after 1 and 2 weeks of treatment. The PC study enrolled 100 patients; the PG study enrolled 110 patients; 204 patients provided efficacy data over both studies. In the PC study, plaque elevation, erythema, and scaling, at least moderately severe at entry, showed at the end of treatment both statistical (p less than or equal to 0.0003) and clinical significance (all greater than 1-unit difference on the rating scale) favoring 0.05% halobetasol ointment over vehicle. Pruritus (initially mild) and total score also showed statistically significant treatment differences favoring halobetasol at the final evaluation. Patient global responses for "effectiveness" and "overall rating" favored 0.05% halobetasol ointment over vehicle. In the PG study, induration, erythema, and scaling, at least moderately severe at entry, showed at the end of treatment both statistically and clinically significant differences favoring 0.05% halobetasol ointment over vehicle. Physician's global evaluation favored 0.05% halobetasol ointment over vehicle after 2 weeks of use. No patients were released from either study because of adverse events. No systemic adverse events or findings of skin atrophy were reported in these studies. Reports of "stings" or "burns" were equally divided between halobetasol and its vehicle.(ABSTRACT TRUNCATED AT 250 WORDS)

A double-blind, vehicle-controlled paired comparison of halobetasol propionate cream on patients with plaque psoriasis

The efficacy and safety of halobetasol propionate 0.05% cream, an ultra high-potency corticosteroid preparation, was evaluated in a double-blind, vehicle-controlled, paired comparison study. Patients' psoriatic lesions were evaluated before treatment and after 1 and 2 weeks of twice-daily treatment with halobetasol propionate and vehicle. Response measures (plaque elevation, erythema, scaling, and pruritus) were evaluated with a 4-point severity scale whereby the sum provided a total score. Patient self-assessment measures were obtained at the 2-week visit by categorizing his or her global responses to queries about each treatment's "effectiveness" and "overall rating." All efficacy parameters, as judged by the physician, showed statistically significant (p = 0.0001) treatment differences favoring halobetasol propionate at both week 1 and week 2 evaluations. Patient global responses for "effectiveness" and "overall rating" favored halobetasol propionate 0.05% cream over vehicle after 2 weeks of use. No systemic adverse drug effects were reported during the study. No patient was discontinued from the study because of an adverse event, and there was no evidence of skin atrophy after 2 weeks of treatment with either agent. Patient reports of "stings" or "burns" were equally distributed between the active and vehicle treatment groups. This trial demonstrates that halobetasol propionate 0.05% cream is clinically beneficial and without evidence of significant risk in the treatment of plaque psoriasis.