Discover the latest psoriasis creams approved for children [2024]

2 to 3% of the world's population is affected by psoriasis. In 40% of the cases, symptoms start before the age of 16, and in 10% of the cases - even earlier in childhood ^1,2. Although many children's symptoms improve with time, some may require life-long treatment to manage this incurable condition. 

While there are multiple treatment options available for adults, including topical treatments, corticosteroids, or biologic therapies, they may not always be suitable for use in children, or may have potential adverse effects.

What if your child's current treatment isn't working and they're not a candidate yet for systemic or biological treatment? Here's a brief overview of the latest psoriasis creams approved for children, which your child's doctor may consider.

Standard topical treatments for kids' psoriasis

Standard first-line treatments for psoriasis in children include topical corticosteroids, calcineurin inhibitors, vitamin D analogues, and emollients. These options are mostly applicable to mild and moderate cases of psoriasis. They are preferred due to their lower risk of side effects compared to systemic medications or biologics. However, long-term use of these treatments can still be associated with side effects, or lead to tolerance and diminish their efficacy.

Corticosteroids in particular are often unsuitable for long-term use, as they can lead to local and systemic side effects including adrenal suppression, Cushing syndrome, growth issues, high blood sugar, and fluid retention. Additionally, rebound effects may occur upon discontinuation, potentially worsening psoriasis symptoms.

Luckily, there are (non-steroid) creams that have recently been approved for use in children with psoriasis. Depending on you child's case, these may offer an alternative treatment.

The newest psoriasis creams approved for children 

Since 2021, there have been multiple FDA approvals for psoriasis treatments. Of these, two are topical treatments applicable to children and adolescents:

• Roflumilast cream (Zoryve) for psoriasis in children

Roflumilast is a non-steroidal PDE4 inhibitor, and is available as a topical cream or foam. The cream addresses the symptoms of plaque psoriasis in children over the age of 6. The foam formulation is FDA-approved for treating seborrheic dermatitis in patients aged 9 and up ³.

Roflumilast efficacy in children

Based on the reported results of the DERMIS-1 and DERMIS-2 trials, 72% of patients treated with Zoryve achieved a 50% reduction in their Psoriasis Area and Severity Index (PASI) score within 8 weeks of treatment. For comparison, 25.5% of placebo patients achieved the same reduction. The percentage of children achieving 100% reduction in PASI after 8 weeks was 12.3% vs 0.8% for the placebo group ⁴.

Roflumilast was also shown to be safe and well-tolerated in children. 

Where is roflumilast cream & foam approved?

Unfortunately, roflumilast cream and foam is currently only approved by the FDA in the USA. There's no active marketing authorization application submitted to the EMA in Europe, and no ongoing MHRA consideration in the UK. This means that it's unlikely to be available on the European market any time soon.

• Halobetasol propionate (Lexette) for psoriasis in children

Halobetasol propionate is a very strong topical corticosteroid that comes in a non-greasy foam formulation. It's approved by the FDA for the treatment of moderate to severe plaque psoriasis in patients 12 years old and up ⁵.  

Lexette efficacy in children

Two clinical trials studied Halobetasol propionate's efficacy in adults, and these were the reported highlights:

• • Study 1: 25% of patients treated with Lexette achieved IGA success at week 2 of treatment (compared to 4% of the placebo group);
  • Study 2: 31% of patients treated with Lexette achieved ISA success at week 2 of treatment (compared to 7% of the placebo group);

A follow-on open label study achieved comparable results in patients aged 12 to 17 years. This subsequent study was the basis for Lexette's FDA approval for use in adolescents ⁶.

According to the reported clinical trial results, Lexette's side effects were comparable to placebo. However, long-term use may be associated with side effects typical for corticosteroids, including HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria ⁷. To minimize the risk, the recommendation is to use halobetasol propionate for up to 2 weeks. 

Where is halobetasol propionate approved?

Currently, halobetasol propionate is only approved in the USA. There's no active application for its approval in the EU or the UK as of February 2024. With this in mind, Lexette is unlikely to be available in Europe soon. 

What if a psoriasis cream for children is not (yet) approved in your country?

Often, the FDA is the first agency in the world to approve new medicines. This also applies to psoriasis treatments, for adult or pediatric use. If you're based outside of the USA and looking for new ways to manage your child's psoriasis, you might be wondering if there's a way to access the newest treatments before they're locally approved.

Yes, there is.

Most countries have regulations in place that allow patients to import medicines that aren't yet approved or available locally, as long as they are prescribed by a doctor and are for personal use only. In these cases, you can buy Zoryve (roflumilast) or other psoriasis creams for children as an Individual Named Patient.

Do you have a prescription for roflumilast cream, or another medicine not yet approved in your country? Our team at Everyone.org can help you access it immediately. Get in touch to find out more.

References:

1. Get the Facts About Psoriasis and Psoriatic Arthritis. National Psoriasis Foundation, Accessed 21 February 2024.
2. Watson, Stephanie. Psoriasis in Kids (Pediatric Psoriasis): Types, Diagnosis, and Treatment. WebMD, 10 June 2023.
3. Stewart, Judith. Zoryve (roflumilast) FDA Approval History. Drugs.com, 2 January 2024.
4. FDA Approves Roflumilast Cream 0.3% In Children 6 to 11 Years With PsO. Dermatology Times, 6 October 2023.
5. Lexette® Foam (halobetasol propionate) | Official Patient Website, Accessed 21 February 2024.
6. FDA Approves LEXETTE (R) for Adolescent Plaque Psoriasis. PR Newswire, 21 September 2021.