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It’s estimated about 2 million people in the United States have the skin condition vitiligo. FG Trade/Getty Images
  • The first at-home therapy for the most common type of the skin condition vitiligo has been approved.
  • Opzelura is a ruxolitinib cream that performed well in recent clinical trials.
  • Experts say the medication provides a convenient alternative for treatment for people with this type of vitiligo.
  • Some consumer advocates are expressing concerns about the limits of the treatment as well as its price.

The Food and Drug Administration (FDA) has approved the first at-home therapy for one type of vitiligo, a disease that causes areas of skin to lose color, resulting in spots and patches of lighter skin.

Vitiligo is an autoimmune disorder affecting as many as 2 percent of the world’s population. It’s estimated that about 2 million adults in the United States have the condition.

The approved treatment is specifically for non-segmental vitiligo, the most common type. It’s also only authorized for individuals 12 years and older.

The FDA approval is a development that is being cheered by many, but for Tonja Johnson, the founder of the vitiligo support group Beautifully Unblemished, there are mixed emotions.

“The treatment is available for those with non-segmental vitiligo so those individuals with segmental vitiligo are not able to use the treatment,” Johnson told Healthline. “People are truly excited about there being a drug which is topical to treat their vitiligo, but there are some who are yet concerned with the possible side effects, especially if you have other health issues and medications that may interfere.”

The treatment is Incyte’s ruxolitinib cream, sold under the brand name Opzelura. The medication works by calming a person’s overactive immune system and eventually helping to grow new, healthy skin cells and returning pigment to the area.

Traditionally, people with vitiligo were limited to light therapies administered in a doctor’s office. Now, they can administer a cream at home.

Opzelura was approved based on data from two clinical trials. These trials involved participants 12 years and older with non-segmental vitiligo that covered 10 percent or less of their bodies.

Participants received ruxolitinib cream or a placebo (usually saline or mineral oil substance) for 24 weeks, after which they could continue through a treatment extension period of 28 weeks.

During the treatment extension period, participants who initially received the placebo were then given the active drug, while those treated with ruxolitinib cream received another 28 weeks of the medication.

At the end of the initial 24-week treatment period, the researchers reported that 30 percent of people using the cream had regained 75 percent or more skin repigmentation on their faces, compared to 10 percent of those using the placebo.

In addition, about 20 percent of participants regained at least 50 percent or more repigmentation on their bodies after 24 weeks. Further, after 6 months to a year of use, the percent of participants experiencing at least 75 percent of face repigmentation increased from 30 percent to nearly 50 percent.

Dr. Erum N. Ilyas, MBE, FAAD, a dermatologist for New York, New Jersey, and Pennsylvania provider Schweiger Dermatology, told Healthline the medication is “a very big deal.”

“We have actually never had a treatment that has been FDA approved specifically for the treatment of vitiligo,” Ilyas said. “The topical therapies currently available are in the category of steroidal and nonsteroidal topicals used to treat vitiligo based on the pathophysiology of the disease.”

Ilyas added the benefits of Opzelura include the ability to use it on most skin areas, an “excellent safety profile compared to the oral versions of this medication,” and efficacy of treatment.

“In particular, this medication has been found to be effective for facial vitiligo,” Erum said. “This is important to note as our ability to use steroid creams on the face is limited due to the potential for side effects. Facial vitiligo tends to be a source of significant concern for our patients and particularly challenging to treat.”

Dr. Harikiran Chekuri, the medical head of holistic healthcare provider Clinicspots in India, told Healthline users will need to exercise patience if they want to see results.

“We know that this chronic skin condition can be both physically and emotionally devastating,” Chekuri said. “There is no cure for vitiligo, but treatment can help to restore the lost pigment in your skin. At-home vitiligo treatment requires patience and commitment, but it can be an effective way to treat the condition.”

“Up until recently, most vitiligo treatments were only available through expensive in-office procedures,” Chekuri noted. “But this new wave of at-home vitiligo treatments are changing the game, making it more accessible and affordable for people with this condition.

“But the process is slow, it may take up to 3 months to show some results,” he added.

Johnson’s Florida-based vitiligo support group is hosting a virtual session with a researcher involved with the trial next week.

She said the organization’s members have a lot of questions about Opzelura, especially about paying what she says could be as much as $1,300 per tube.

“Currently in the vitiligo world most insurance companies look at vitiligo as cosmetic, so, therefore, it can be hard to get those prior authorizations as well get the meds covered by insurance companies,” Johnson said.

“I do know that if the insurance covers it, the insurance company will pay 80 percent and the patient 20 percent, or a co-pay. There’s also a savings card for patients where they can get the prescription for as low as $10,” she noted.