Heal House Vitiligo Research 54 · Original Article
How effective is the new vitiligo drug LITFULO?
Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial
In short
This is an international clinical trial that checked whether the new oral drug LITFULO (ingredient name ritlecitinib) is effective for vitiligo. 364 people participated, and the white areas on the face noticeably decreased.
For a long time, vitiligo treatment has centered on topical medications and phototherapy. The idea of "restoring color with an oral medication" was close to a hope. But with the emergence of JAK inhibitors that block the immune signals of vitiligo, that hope has been put to the test. This international clinical trial, in which I participated as a co-investigator, is a phase 2b study that examined whether the oral drug LITFULO is truly effective and safe for active vitiligo.
Q1 How was the trial conducted?
364 patients with active nonsegmental vitiligo were randomly divided into several dose groups and a placebo group. They took the medication daily for 24 weeks. Improvement was measured by the percentage change from baseline in the facial vitiligo area scoring index, a scale that measures the area of white patches on the face. The study then followed patients for an additional 24 weeks to see whether the effect persisted. Neither the patients nor the Dermatologist knew who was receiving the real drug, so the results could be evaluated relatively fairly.
Q2 What were the efficacy and safety results?
Patients who took LITFULO showed a clear reduction in white patches on the face compared with those who took placebo. Those who took 50 mg experienced about a 21% reduction in facial white patches at 24 weeks. In contrast, those who took placebo actually showed a slight increase. The 50 mg group used a loading dose (higher dose for the first few weeks). In the table below, a negative number means that the white area decreased and color returned. In terms of safety observed up to 48 weeks, there was no clear trend of increased side effects with higher doses. The treatment was generally well tolerated.
Change in Facial Vitiligo Area Scoring Index at 24 weeks
| Treatment group | Area change | In simple terms |
|---|---|---|
| Placebo | +2.1% | Did not decrease; actually increased slightly |
| LITFULO 30 mg | -14.6% | Decreased by about 15% |
| 50 mg (without loading) | -18.5% | Decreased by about 19% |
| 50 mg (with loading) | -21.2% | Decreased by about 21% |
Q3 What do these results mean for people with vitiligo?
The most significant point is that this clinical trial has shown the possibility of restoring color in vitiligo with an oral medication. It could become a new option for active vitiligo that is too extensive to apply topical treatment or is spread over multiple areas. However, I must clearly state that LITFULO is currently approved in Korea only for the treatment of severe alopecia areata, and vitiligo is not an approved indication. More research is needed before it can be used for vitiligo. This study is also a phase 2b trial that enrolled only patients with "active" rather than stable vitiligo, so larger follow-up studies remain. Nevertheless, it is a welcome signal that the treatment horizon is expanding.
Closing remarks
Beyond topical and light-based treatments, the path of an "oral medication" is opening. This study adds hope for vitiligo patients. I participated as a co-investigator, and the experience of being part of such an international clinical trial greatly helps me convey the latest developments to patients in Korea. Of course, new drugs must be carefully established after longer observation of efficacy and safety. I do not forget that point.
