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Calcipotriol plus betamethasone dipropionate gel is safe, effective for the Tx of adolescent patient

Cosmetically appealing and easy-to-use gel may help encourage patient compliance

Calcipotriol plus betamethasone dipropionate gel appears to be an efficacious and well-tolerated option for the treatment of moderate scalp psoriasis in adolescents, according to a study reported in the British Journal of Dermatology (Dec. 2014; 171(6):1470-1477).

The trial was designed to determine the tolerability and effectiveness of calcipotriol plus betamethasone dipropionate gel that has already demonstrated to be a safe and efficacious for the treatment of scalp and body psoriasis in adults, said Dr. Melinda Gooderham, dermatologist and medical director at the SKiN Centre for Dermatology in Peterborough, Ont. She is also an assistant professor at Queen’s University in Kingston, Ont.

“Essentially we wanted to prove that this gel is not only safe but efficacious for the treatment of adolescents, since we use a lot of treatments off label due to the fact that we have limited options to safely and effectively treat our pediatric patients,” said Dr. Gooderham, the lead author of the study.

“Often times we use adult therapies blindly to treat children and adolescents without knowing if the treatments are safe for this patient population. We assume a treatment works as it does in our adult population of patients, but sometimes we do not really have data to back it up.”

Patient trial inclusion and exclusion summarized

Dr. Gooderham and her colleagues reported that this phase II, multicentre, single-arm, open-label, eight-week trial involved 78 patients between 12 and 17 years of age who had a diagnosis of psoriasis vulgaris affecting >10% of the scalp and at least moderate in severity, according to Investigator’s Global Assessment (IGA).

This investigation involved a three-part trial consisting of a washout/screening period, a treatment period and a follow-up period, the authors wrote. A washout period of up to eight weeks was applicable if patients had received antipsoriatic treatments or other relevant medication as outlined in the exclusion criteria.

There were a number of reason for the establishment of the exclusion criteria. According to the authors, patients were excluded if they had a history of hypersensitivity to any component of the fixed-combination topical gel, topical treatment on the trunk and/or limbs with very potent (World Health Organization group IV) corticosteroids or on the face and/or genital/skin folds with potent or very potent (World Health Organization groups III–IV) corticosteroids, within two weeks prior to baseline or during the trial.

Additionally, the authors reported that patients were also excluded from participating in this trial if they had received systemic treatment with adalimumab or infliximab within two months, etanercept within four weeks, ustekinumab within four months, or experimental biologics within four weeks/five half-lives prior to baseline.

Gel applied once-daily found safe and efficacious

The study participants during the trial assessment period were instructed to apply the calcipotriol 50 μg (g-1) plus betamethasone 0.5 mg (g-1) gel to the scalp once-daily for up to eight weeks. During the treatment period patients were permitted the concomitant use of other topical antipsoriatic treatments (including vitamin D analogues), except for corticosteroids, on the trunk, limbs or face, but no other scalp products were allowed during the duration of the assessment.

Patients whose scalp psoriasis had cleared after four weeks of treatment completed the trial (n=13). Similarly, those patients who had remaining signs of scalp psoriasis after four weeks continued treatment for an additional four weeks.

Overall, the findings revealed that 56% of the participants (n=46) were fully compliant or missed <10% of the applications. The mean weekly use of the gel was 36 g (range four to 69 g), and, comparing the first four weeks with the second four weeks of treatment, there was no decrease in weekly use over time, the authors reported.

In all, the authors wrote that 27 patients (35%) reported a total of 64 adverse events (AEs); most were mild (33/64) or moderate (22/64) in severity and there were no serious AEs. No cases of hypercalcaemia were reported, and the mean changes from baseline to end of treatment in albumin-corrected serum calcium (0.00 mmol L(-1)), 24-h urinary calcium excretion (-0.03 mmol per 24 h) and urinary calcium-to-creatinine ratio (-0.12 mmol g(-1) were not considered clinically relevant.

“We were pleased to find out that the safety and tolerability profile of [calcipotriol plus betamethasone dipropionate gel] was similar to what has previously been reported in adult studies,” said Dr. Gooderham.

At the end of treatment, data revealed that 66 patients (85%) were clear or almost clear according to IGA. In addition, the researchers reported that there was an 80% improvement in mean Total Sign Score from baseline to end of treatment. In total, at the end of treatment, 87% of patients rated their scalp psoriasis as clear or very mild, and 75 patients (96%) had no or mild pruritus compared with 14 participants (18%) at baseline.

“It was reassuring and surprising to find out that this gel worked as well as it has in adults for the treatment of scalp psoriasis, because adolescents are notoriously non-adherent to treatment,” she said.

“I have to admit that sometimes in a clinical setting such as this one, the results can be somewhat artificial due to the adolescent participants frequent office clinical visits and patient treatment reminders.”

Gel cosmetically appealing for adolescents to use

Overall, Dr. Gooderham stated that calcipotriol plus betamethasone dipropionate gel is cosmetically appealing and easy for patients to use, which is expected to help to encourage patient treatment compliance.

“We already know that pediatric patients generally are not going to follow through with using products that are not cosmetically acceptable or unappealing. Young patients are more likely to use products that are easy to use,” she concluded.

“Aside from this gel, topical steroids are another option available for adolescents. Topical steroids, however, have to be applied twice-daily, whereas this gel only has to be applied once-daily. Also, many topical steroids are alcohol-based and patients tend to not like them because the products sting when applied to scratched or open areas on the skin or scalp.”

Previously published in The Chronicle of Skin & Allery.

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