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FDA approves topical cream for non-segmental vitiligo treatment - Yara.ng
Home Health & Food FDA approves topical cream for non-segmental vitiligo treatment 

FDA approves topical cream for non-segmental vitiligo treatment 

by James Davies


Oluwatobiloba Jaiyeola

The United States Food and Drug Administration has approved a cream called Opzelura as the first pharmacologic treatment to address the most common form of vitiligo.

The FDA stated that the approved treatment is particularly for non-segmental vitiligo, adding that only individuals 12 years and older are authorised to use the cream.

Non-segmental vitiligo is an autoimmune disorder where pale white patches develop on the skin and is caused by the lack of melanin.

Depigmentation may occur on the face, neck, and scalp, and around body openings such as the mouth and genitals, as well as areas that tend to experience rubbing or impact, such as the hands and arms.

The skin condition affects as many as two per cent of the world’s population and about two million grown-ups in the US have the condition.

According to the FDA, many people with vitiligo are also affected by at least one other autoimmune disorder.

Opzelura, which is made and owned by Incyte Dermatology, is a ruxolitinib cream. It is a topical Janus kinase inhibitor (JAK) that works by calming a person’s overactive immune system and eventually assisting to grow new and healthy skin cells while restoring pigment to the affected area.

Its approval for use against vitiligo was based on the results of two clinical trials conducted. 

The trials involved participants with non-segmental vitiligo that covered 10 per cent or less of their bodies.

Each trial participant was administered Opzelura or placebo cream twice daily for 24 weeks, after which they continued treatment with Opzelura, for an additional 28 weeks.

At the end of the 24-week treatment period, the researchers discovered that 30 per cent of the patients using Opzelura patients had at least 75 per cent improvement in the skin repigmentation on their faces, in comparison with 10 per cent of those using the placebo cream.

After six months to a year of treatment, the percentage of participants experiencing at least 75 per cent of face repigmentation increased from 30 per cent to almost 50 per cent.

The FDA said the most common adverse effects associated with the use of Opzelura are application site acne, application site itching, common cold, headache, urinary tract infection, application site redness, and fever.

“Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended,” the FDA advised.

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