Clobex^® Spray, 0.05%

Indication

Clobex^® Spray, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Treatment should be limited to 4 consecutive weeks. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with Clobex^® Spray, 0.05%.¹

Dosage

The total dosage should not exceed 50 g (59 mL or 2 fl oz) per week. Do not use more than 26 sprays per application or 52 sprays per day. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression. Patients should be instructed to use Clobex^® Spray, 0.05%, for the minimal amount of time necessary to achieve the desired results. Use in patients under the age of 18 years of age is not recommended.¹

Use

Clobex^® Spray, 0.05%, should be sprayed directly onto the affected skin areas twice daily and rubbed in gently and completely. Clobex^® Spray should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin or axillae.¹

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Consistent Results on the Body

• In two Phase 3 trials, an average of 80% of patients were clear or almost clear at 4 weeks¹

*Two 4-week, multicenter, randomized, double-blind, vehicle-controlled, parallel-group studies of patients with moderate to severe plaque psoriasis to evaluate the efficacy and safety of clobetasol propionate spray, 0.05%, BID (n=120) or its vehicle BID (n=120). The primary efficacy endpoint was overall disease severity.^1,2

^†The statistical comparison of success rates resulted in a significant difference between Clobex^® Spray and vehicle (P<.001).²

Individual results may vary.

In the controlled clinical trials with Clobex^® Spray, 0.05%, the most common adverse event was burning at the site of application (40%). Most local adverse events were rated as mild to moderate and were not related to age, race, or gender. Adverse events that occurred at a rate greater than 1% in the Clobex^® Spray treatment group include application site dryness (2%), application site pruritus (3%), nasopharyngitis (5%), upper respiratory tract infection (8%) and eczema asteatotic (2%).¹

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Consistent results in a large-scale, community-based trial (N=1985)

• 80% of patients achieved target plaque severity (TPS) success (clear or almost clear or 2 grades of improvement) (P<.001)¹

*A 4-week, open-label, multicenter study evaluating effectiveness and safety of Clobex^® Spray as add-on therapy or monotherapy (n=731).

Individual results may vary.

The most frequently reported adverse events that were probably or possibly related to study medication were generally related to the application site for study medication or to the underlying condition, and were application site irritation, dry skin, pain, or pruritus. With one exception (application site irritation, probably related, reported for 1.3% of add-on therapy subjects), all adverse events probably or possibly related to study medication were reported by <1.0% of subjects in either group.²

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Clobex^® Spray vs Taclonex^® Ointment

*A 4-week, randomized study comparing efficacy, safety, quality of life and patient satisfaction with Clobex^® Spray BID vs Taclonex^® Ointment QD in patients with moderate to severe plaque psoriasis. Dosing was according to approved product labelling for each product (n=93).

• Similar disease improvements were observed for both products based on Investigator Global Assessment (IGA) of body surface area (BSA) involvement — IGA success rates defined as mild and clear

Patient 017-009

Patient 019-014

Individual results may vary.

More patients were satisfied with Clobex^® Spray treatment than with Taclonex^® Ointment.¹

• Patient satisfaction scores were higher with Clobex^® Spray based on:
  • Ease of application
  • Satisfaction with appearance
  • Satisfaction with results
  • How it compares to previous treatments
  • Willingness to use it again

Clobex^® Spray was well tolerated^1,2:

• Both treatments were generally well tolerated, with more patients reporting stinging/burning with Clobex^® Spray
  • Majority of patients in the Clobex^® Spray treatment group reported no (51%) or mild (37%) stinging and burning

For patients in both groups, the minority of adverse events were considered related or possibly related to the study medications. The most common of these were application site reactions or worsening of psoriasis. Reported adverse events were similar for the 2 treatment groups. No patients experienced serious adverse events.

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Clobex^® Spray, 0.05%, provides rapid relief from scalp psoriasis¹

*From a multicenter, randomized, double-blinded, vehicle-controlled study designed to assess the treatment of moderate to severe plaque psoriasis of the scalp with Clobex^® Spray or vehicle spray for up to 4 weeks. The primary endpoint was GSS of scalp psoriasis at Week 4 (N=81).

• At study end, 85% of patients treated with Clobex^® Spray were clear or almost clear (n=41) vs 13% of patients treated with vehicle (n=40) (P<.001)¹

Adverse events reported with use of Clobex^® Spray on the scalp included moderate burning sensation and alopecia.

Patient: 053-0171
Individual results may vary.

80% of patients agreed or strongly agreed that the directional nozzle made it easy to apply Clobex^® Spray to plaques on the scalp.¹

Click here for full Prescribing Information for Clobex^® Spray.