In studies, Enstilar Foam (calcipotriene / betamethasone dipropionate) has been used safely and effectively to treat scalp psoriasis in adults and adolescents ages 12 to 17 years of age. Foam preparations are often preferred by patients with scalp psoriasis (over ointments or thick creams) and the ingredients in Enstilar Foam are considered standard first-line treatments.

• Plaque psoriasis is a skin condition often found on the elbows, knees, scalp and lower back. Psoriasis appears as red lesions with silvery white scales that may itch, burn or bleed.
• Up to 50% to 80% of patients may experience a flare-up of plaque psoriasis on their scalp, which can cause scarring, hair loss and psychological distress.
• The exact cause of psoriasis is not known, but it is thought to be caused by an immune system disruption that leads to rapid skin cell growth. Symptoms are often managed with topical treatments.

Always follow your doctor’s instructions. Your healthcare provider will tell you how much Enstilar Foam to use and where to use it. It is usually applied once daily to the affect area for up to 4 weeks. Do not use more than 60 grams of Enstilar Foam every 4 days.

What is Enstilar Foam?

Enstilar Foam is a prescription topical spray foam approved by the FDA for treatment of plaque psoriasis in adults and adolescents 12 years of age and older. Each gram of Enstilar Foam 0.005% / 0.064% contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate. It is applied once daily for up to 4 weeks.

• Calcipotriene is a topical vitamin D analog and works by slowing down the overproduction of skin cells commonly seen in psoriasis.
• Topical corticosteroids, like betamethasone dipropionate, help to reduce inflammation, redness, itching and pain. Betamethasone is considered a high-potency topical corticosteroid.

It is important to see your doctor and have the correct strength of corticosteroid cream prescribed for your specific condition and area that needs to be treated. Only use topical steroids on your face, groin, or axillae (underarm area) if directed by your doctor. Do not use Enstilar foam in your mouth, eyes or vagina.

Also, do not use bandages, wraps or occlusive dressings of any type on the area unless your doctor directs you to do so. Side effects are more likely to occur if the area is covered or wrapped, or with extensive or prolonged use of high strength medicines.

Enstilar Foam is manufactured by LEO Laboratories Ltd.

Safety of Enstilar

Enstilar Foam is well-tolerated by most patients. Overall, in studies submitted to the FDA for approval, side effects reported in less than 1% of all patients in studies included:

• Irritation
• Itching
• Inflamed hair pores (folliculitis)
• Changes in skin color
• Rash with red bumps or skin welts (hives)
• Worsening of psoriasis

Other types of more serious side effects can include:

• Changes in your blood or urine calcium levels
• Absorption of the drug into your bloodstream which may cause your adrenal glands to stop working properly
• Cushing’s syndrome (this occurs when your body is exposed to too much of the hormone cortisol)
• High blood sugar levels or sugar in your urine
• Skin changes, like thinning of your skin, itching or redness
• Allergic contact dermatitis
• Increased chance of getting cataracts and glaucoma

Related: Side effects and warnings with Enstilar (in more detail)

Effectiveness of Enstilar for scalp psoriasis

In 2 Phase II studies in 408 adults and adolescents (12 to <17 years of age) with at least mild psoriasis of the scalp, participants received either a fixed-dose combination of calcipotriene monohydrate 0.005% and betamethasone dipropionate 0.064% (Cal/BD, Enstilar) foam, calcipotriene (Cal) foam (0.005%) or betamethasone dipropionate (BD) foam (0.064%).

The foam was applied once per day to scalp psoriasis lesions. Treatment success was based on improvement (Physician Global Assessment) after 4 weeks of treatment.

• In adults, treatment results with Cal/BD foam (Enstilar) was statistically greater when compared to the Cal foam (53% vs. 35.6%, P=0.021). Cal/BD foam was numerically higher but was not found to be significantly more effective (47.5%, P=0.45) when compared to only the betamethasone dipropionate foam.
• A reduction in mean percent PASI scores (Psoriasis Area and Severity Index) of 80%, 57.8% and 71.2%, for Cal/BD, Cal and BD foam, respectively, were seen. A PASI score is a tool used to measure the severity and extent of psoriasis in patients.
• In adolescents, 73.6% of patients treated with Cal/BD foam achieved treatment success and mean scalp surface area (SSA) of psoriasis fell from 50.6% at baseline to 12.5% after 4 weeks of treatment.

Side effects were primarily considered mild-to-moderate in both studies. One participant had to withdraw from the study due to a severe hypersensitivity (allergic) reaction with hives to Cal/BD (Enstilar Foam).

Additional safety in adolescents

A Phase II, 4-week long, open-label study assessed safety of calcipotriene / betamethasone (Cal/BD) dipropionate foam for body and scalp psoriasis in adolescents 12 to <17 years of age. Patients had at least mild psoriasis and Cal/BD foam was applied once daily for no more than 4 weeks.

In the treatment population, success to treatment was seen in 71.8% of patients on their body and 75.7% of patients on their scalp. When compared to the start of treatment, the mean PASI (Psoriasis Area and Severity Index) score decreased by 82% at Week 4.

Researchers evaluated patients for side effects during treatment and measured systemic calcium levels, HPA-axis function, change in calcium excretion and calcium:creatinine ratio in the HPA-axis cohort. There was no evidence for meaningful changes of the HPA-axis nor calcium regulation.

• Calcipotriene treatment can lead to systemic absorption leading to hypercalcemia (too much calcium in the blood). High calcium levels can lead to weakened bones, kidney stones, and rarely interfere with how your heart or brain function.
• Cortisol is the natural stress hormone produced in humans. Prolonged use of potent topical corticosteroids, like betamethasone, may suppress the HPA axis and reduce cortisol production. With low cortisol levels, response to stressful events, like illness or surgery, may be hindered and a risk for infection can increase.

About 21% of patients (22 /106) experienced a total of 32 treatment-emergent adverse effects. The most frequent adverse effects were upper respiratory tract infection (7.5%), common-cold symptoms / nasopharyngitis (3.8%), and acne (1.9%) patients. All but two side effects were considered mild, and no patients withdrew from the study.

• Changes in calcium levels, urinary calcium excretion were not considered clinically significant.
• In the HPA-axis cohort, no changes were seen in the urinary calcium:creatinine ratio. Disruption to the HPA-axis due to systemic steroid absorption from adrenocorticotropic-hormone (ACTH) challenge was not seen. All patients had normal cortisol levels by 60 min post‐ACTH challenge.
• Systemic exposure (absorption) to Cal/BD was minimal.

Observational, real-world Enstilar study in adults

In a prospective, observational, 4-week study in 217 adults, researchers looked at the effectiveness and safety of Cal/BD (Enstilar) spray foam in patients with scalp psoriasis in clinical practice. Enstilar was applied once daily to the affected scalp area for 4 weeks.

At the end of the study, 53.4% of patients (103) treated with Enstilar foam had achieved a Scalp-BSA (percentage of affected scalp area) of less than 10% of the affected scalp area and a "mild" Scalp Physician Global Assessment (Scalp-PGA), which were primary endpoints.

• The mean ± SD Scalp-BSA decreased during treatment from 32.5 ± 19.0% pretreatment to 10.9 ± 12.5% after 4 weeks (p < 0.001).
• 47.6% of patients achieved a Psoriasis Scalp Severity Index (PSSI) ≤2, also a primary endpoint. The PSSI measures the extent and severity of psoriasis on a physician rated-scale from 0 to 72, where 0 equals no psoriasis, and higher scores mean more severe disease.
• Patient satisfaction with treatment was high and physicians rated Enstilar tolerability as good or very good with no new safety concerns.

How long does it take for Enstilar to work on the scalp?

In a 4-week long study, improvements in symptoms like itching, redness and scaling started to improve in 3 days when Enstilar was applied once daily to scalp psoriasis.

• At the end of the 4 weeks, 69.1% of patients rated their scalp itching as none or mild and 25.3% of patients rated as moderate.
• Severe or maximal itching was still present in only 5.6% of patients after 4 weeks of daily treatment.

Learn more: Is Enstilar Foam used to treat plaque psoriasis?

This is not all the information you need to know about Enstilar Foam (betamethasone and calcipotriene topical) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.