Important Safety Information

Indication: CLOBEX® Spray 0.05% is indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area in adults 18 years of age or older.

Adverse Events: In controlled clinical studies, the most common adverse reactions (> 2%) were burning, pruritus, nasopharyngitis and upper respiratory tract infection. Local adverse reactions may occur more frequently with the use of occlusive dressings.

Warnings/Precautions: Clobetasol propionate has been shown to suppress the HPA axis at the lowest doses tested. Treatment should be limited to 4 weeks. The total dosage should not exceed 50 g (59 mL or 2 fl oz) per week. Do not use more than 26 sprays for each application or more than 52 sprays in 1 day.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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Clobex® Spray Savings Program

With the online savings program, you may be eligible to pay no more than $25 for Clobex® Spray in 2.0 fl oz and 4.25 fl oz bottles. This offer is also good for refills. Maximum savings on 2.0 fl oz bottles is $125. Maximum savings on 4.25 fl oz bottles is $250. You must present a valid prescription to your pharmacist along with your coupon. Payment will be dependent upon actual insurance coverage.

THIS OFFER IS AVAILABLE FOR A LIMITED TIME ONLY AND GALDERMA LABORATORIES RESERVES THE RIGHT TO RESCIND, REVOKE, AMEND, OR TERMINATE THIS OFFER AT ANY TIME WITHOUT NOTICE.

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Terms & Conditions

Eligibility Requirements: Offer not valid for prescriptions reimbursed or paid in part or full by any state or federally funded programs, including but not limited to Medicare or Medicaid, Medigap, VA, DOD, or TriCare. MSAZ is not responsible for any transactions processed under this program where Medicaid, Medicare, and Medigap (“Government Program”) payment, in part or full, has been applied. Only patients who reside in the 50 states can participate in the CLOBEX® Spray PNMT $25 NELS Program. Cash-paying customers are not eligible for this program. There are age restrictions to this program—patients must be 18 years or older. There are no gender restrictions to this program. Each patient is eligible for 12 benefits, each consisting of a $25 copay for the patient with a maximum cap of $250 for CLOBEX® Spray 4.25 fl oz and $125 for CLOBEX® Spray 2.0 fl oz.*

To the Patient: This offer is for insured patients only. You must present this card to the pharmacist along with your prescription to participate in this program. You are not eligible if prescriptions are paid by any state or other federally funded programs, including, but not limited to Medicare or Medicaid, Medigap, VA, DOD or TriCare, or where prohibited by law; and you agree to the conditions below. Maximum benefits may apply. Payment will be dependent upon actual insurance coverage. For complete terms and conditions visit www.clobex.com.

To the Pharmacist: When you use this card, you are certifying that you have not submitted and will not submit a claim for reimbursement under any federal, state or other governmental programs for this prescription.

  • Submit transaction to McKesson Corporation using BIN #610524
  • If primary coverage exists, input card information as secondary coverage and transmit using the COB segment of the NCPDP transaction. Applicable discounts will be displayed in the transaction response
  • Acceptance of this card and your submission of claims for the Clobex® Spray Savings Program are subject to the LoyaltyScript® program Terms and Conditions posted at www.mckesson.com/mprstnc
  • Patient is not eligible if prescriptions are paid in part or full by any state or federally funded programs, including but not limited to Medicare or Medicaid, Medigap, VA, DOD or TriCare and where prohibited by law
  • For questions regarding setup, claim transmission, patient eligibility or other issues, call the LoyaltyScript® for Clobex® Spray Savings Program at 1-877-264-2440 (8:00 AM-8:00 PM EST, Monday-Friday)
*Maximum reimbursement limits apply; patient out-of-pocket expense may vary.

THIS OFFER IS AVAILABLE FOR A LIMITED TIME ONLY AND GALDERMA LABORATORIES RESERVES THE RIGHT TO RESCIND, REVOKE, AMEND, OR TERMINATE THIS OFFER AT ANY TIME WITHOUT NOTICE.

© 2013 Galderma Laboratories, L.P. All rights reserved.

CLOBEX® (clobetasol propionate) Spray, 0.05% scalp efficacy

For the treatment of moderate to severe plaque psoriasis for up to 4 weeks in adults.

Rapid and powerful efficacy on the scalp1

Severity chart
*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 (n=41) or vehicle spray (n=40) for up to 4 weeks. The primary endpoint was GSS of scalp psoriasis at week 4/end of treatment (EOT). Pruritus severity at weeks 2 and 4/EOT was a secondary endpoint. EOT was at week 4, or at week 2 for those with GSS=0 (clear) at week 2.1

Baseline
Baseline
Week 2
Week 2
Patient 067-0042*
Individual results may vary.
  • Treatment-related adverse events reported with use of CLOBEX® (clobetasol propionate) Spray, 0.05% on the scalp included moderate burning sensation and alopecia2*
References: 1. Sofen H, Hudson CP, Cook-Bolden FE, et al. Clobetasol propionate 0.05% spray for the management of moderate-to-severe plaque psoriasis of the scalp: results from a randomized controlled trial. J Drugs Dermatol. 2011;10:885-892. 2. Data on file. Galderma Laboratories.

CLOBEX® (clobetasol propionate) Spray, 0.05%: Results shown after 1 week

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Results that last5

  • Over 50% of patients treated with CLOBEX® Spray remained clear or almost clear from 2 weeks of treatment until 4 weeks posttreatment5
Clinical Success chart
*From 2 randomized, vehicle-controlled clinical trials that were identically designed to assess efficacy and safety of CLOBEX® Spray (n=60 in each study) or vehicle spray (n=60 in each study) in patients with moderate to severe plaque psoriasis for up to 4 weeks. Patients were evaluated on their Overall Disease Severity (ODS). A follow-up clinical evaluation was conducted 4 weeks after the end of treatment. Average values for the 2 studies are shown.3,5

  • The most common adverse reactions (>2%) were burning, prurituys, nasopharyngitis and upper respirator tract infection5

CLOBEX® SPRAY: POWERFUL EFFICACY FROM THE START5

In 2 pivotal phase III trials, an average of 80% of patients using CLOBEX® (clobetasol propionate) Spray, 0.05%, were reported clear or almost clear at week 4 (n=120)3*

  • At week 1, 74% of patients showed improvement in ODS of at least one grade4†
  • In a post hoc analysis, an average of 67% of patients using CLOBEX® Spray were reported almost clear or mild (P <.001)4
Average ODS score distribution chart
*From 2 randomized, vehicle-controlled clinical trials that were identically designed to assess efficacy and safety of CLOBEX® Spray (n=60 in each study) or vehicle spray (n=60 in each study) in patient with moderate to severe plaque psoriasis for up to 4 weeks. Patients were evaluated on their ODS. Average values for the 2 studies are shown.3 From a post hoc analysis of 2 pivotal phase III trias to assess efficacy and safety in the treatment of moderate to severe plaques psoriasis with CLOBEX® Spray (n=60 in each study) or vehicle spray (n=60 in each study). The post hoc analysis was conducted using all the data and the median as the measure of central tendency, evaluating ODS, erythema, plaque elevation, scaling, and pruritus improvement from baseline at week 1. Average values for the 2 studies are shown.4

  • The most common adverse reaction was burning at the site of application (40% of patients treated with CLOBEX® Spray and 47% of patients treated with vehicle)3*
References: 3. Clobex® Spray Prescribing Information. January 2011. 4. Brodell R, Preston N. Improvement in signs and symptoms of plaque psoriasis after 1 week of treatment with clobetasol propionate 0.05% spray. J Drugs Dermatol. 2012;11:1455-1459. 5. Data on file. Galderma Laboratories.

CLOBEX® (clobetasol propionate) Spray, 0.05%: A comprehensive psoriasis treatment6-11

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Class 1 strength patients can count on for up to 4 weeks8-10

CLOBEX® (clobetasol propionate) Spray, 0.05%, contains the only super-high potent corticosteroid formulation that can be used for 4 consecutive weeks.

Simplify the treatment process with a unique spray formulation7,10

CLOBEX® Spray is formulated to easily penetrate the epidermis and dissolve quickly into the skin on the body and/or scalp. Clobex diagram
*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 (N=81).6 In the patient-reported satisfaction survey, patients rated their responses on a scale of 1 through 10 (1 being the worst, 10 being the best).6,7


Consistent Relief on the Body in Over 2000 Patients9,12

An average of 80% of patients using CLOBEX® Spray were reported clear or almost clear at week 4 in two pivotal Phase III trials (n=120).8


Significant results with CLOBEX® Spray vs TACLONEX® Ointment7,9

Treatment Success in Overal Disease Severity chart
From a 4-week, randomized study comparing efficacy, safety, quality of life and patient satisfaction with CLOBEX® Spray BID (n=44 per protocol) vs TACLONEX® (calcipotriene 0.005%/betamethasone dipropionate 0.064%) Ointment QD (n=49 per protocol) in patients with moderate to severe plaque psoriasis. Dosing was according to approved labeling for each product, with a maximum dosage of 50 g/week for CLOBEX® Spray and 100 g/week for TACLONEX® Ointment (n=93 per protocol).9
  • 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)9‡
  • Both treatments were generally well tolerated, with more patients reporting mild stinging/burning with CLOBEX® Spray9‡

Clinical trial evidence

The images below illustrate psoriasis relief experienced by patients involved in clinical trials.

Localized7,9
Localized comparison Patient 017-0097
Individual results may vary.

From a 4-week, randomized study comparing efficacy, safety, quality of life and patient satisfaction with CLOBEX® Spray twice a day vs TACLONEX® Ointment once a day in patients with moderate to severe plaque psoriasis. Dosing was according to approved labeling for each product (N=122).9
Widespread7,12
Widespread comparison Patient 3531-PJM7
Individual results may vary.

From a 4-week, open-label, multicenter study evaluating efficacy and safety of CLOBEX® Spray as monotherapy or add-on therapy (N=2488).12
References: 6. Sofen H, Hudson CP, Cook-Bolden FE, et al. Clobetasol propionate 0.05% spray for the management of moderate-to-severe plaque psoriasis of the scalp: results from a randomized controlled trial. J Drugs Dermatol. 2011;10:885-892. 7. Data on file. Galderma Laboratories. 8. Clobex® Spray Prescribing Information. January 2011. Galderma Laboratories, L.P. 9. Menter A, Abramovits W, Colón LE, Johnson LA, Gottschalk RW. Comparing clobetasol propionate 0.05% spray to calcipotriene 0.005% betamethasone dipropionate 0.064% ointment for the treatment of moderate to severe plaque psoriasis. J Drugs Dermatol. 2009;8:52-57. 10. Menter A. Topical monotherapy with clobetasol propionate spray 0.05% in the COBRA trial. Cutis. 2007;80:12-19. 11. Kircik LH, Bikowski JB, Cohen DE, Draelos ZD, Hebert A. Vehicles matter: Clinical implications of delivery and application systems. Part 2 of 2. Practical Dermatol. 2010;(suppl):1-16. 12. Koo JYM. Relevance of the COBRA trial in current psoriasis practice. Cutis. 2007;80(suppl 5):4-11.

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CLOBEX® (clobetasol propionate) Spray, 0.05% as part of a sequential treatment regimen

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A powerful option for initial relief

Majority of patients clear, almost clear or mild

  • Initial relief with CLOBEX® (clobetasol propionate) Spray, 0.05%: 80% of patients were clear, almost clear or mild by week 2; 93% of patients were clear, almost clear or mild by week 4 (n=170)13
  • Sustained benefit: 74% of patients were clear, almost clear or mild at week 12 (n=170) with VECTICAL® (calcitriol) Ointment13
  • The primary endpoint of this trial was overall disease severity (ODS)13
Significantly reduced BSA affected chart
*Open-label, multicenter study of patients with moderate to severe plaque psoriasis evaluated the efficacy and safety of 4 weeks of CLOBEX® Spray followed by 8 weeks of VECTICAL® Ointment. Only patients whose Overall Disease Severity (ODS) was assessed as clear, almost clear, mild or moderate at week 4 received VECTICAL® Ointment. The primary endpoint was ODS. Secondary endpoints included change from baseline in BSA (n=170 per protocol). Success was defined as an ODS score that resulted in at least one grade improvement from baseline at week 12.
  • Throughout the study, the most frequent adverse events and tolerability assessment issues reported were application site irritation, pruritus, stinging/burning, folliculitis, skin atrophy and telangiectasias. The adverse event profiles during each phase of the study were generally consistent with those established for each respective medication.13


Visible differences through 12 weeks

Skin comparison
Clobex bottle
Reference: 13. Data on file. Galderma Laboratories.

important safety information

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Important Safety Information for VECTICAL® (calcitriol) Ointment

Indication: VECTICAL® Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older. Adverse Events: In controlled clinical studies, the most commonly reported adverse reactions (≥ 3%) were lab test abnormality, urine abnormality, psoriasis, hypercalciuria, pruritus, and skin discomfort. Warnings/Precautions: The maximum weekly dose should not exceed 200 g. Avoid contact with eyes, lips and face. VECTICAL® Ointment should be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics and in patients receiving calcium supplements or high doses of Vitamin D. If aberrations in parameters of calcium metabolism are noted discontinue VECTICAL® Ointment until these normalize. Avoid excessive exposure of VECTICAL® Ointment treated areas to either natural or artificial sunlight.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

Click here for Full Prescribing Information for VECTICAL® Ointment