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A new, innovative, and safe treatment in vitiligo: Results of a randomized, double-blinded, parallel-group study
Christian Diehl1, Roxanna Sadoughifar1,2, Iva Binic3
1Department of Dermatology, University of Rome G. Marconi, Rome, Italy.
Abstract:
Vitiligo is a chronic autoimmune disease affecting around 1% of the population worldwide. No existing treatment is giving fully satisfactory results. Further investigations are welcomed for innovative and safe treatments bringing better results. This trial aimed to compare the efficacy and tolerance of various treatment protocols on vitiligo lesions. Four randomized groups of 10 patients with vitiligo covering 8% to 14% of skin surface, except hands and feet were assigned during 8 weeks to (a) UVB microphototherapy 300 to 320 nm (Bioskin-) 1 x week; (b) VITILSI- gel 2 x day; (c) VITILSI- gel 2xday + Bioskin- 1 x week; and (d) placebo 2 x day. Efficacy of the treatment was assessed by planimetry, comparing the photographs of the patients taken at baseline and after 8-week treatment. After completion of the treatment, the increase of the pigment area was 28% in G1 (Bioskin-), 19% in G2 (VITILSI-), 41% in G3 (Bioskin- + VITILSI-) and null in G4. No subject stopped the treatment and no side effect was observed. It was demonstrated that the gel under study was able per se to induce repigmentation in vitiligo lesions and that the results were significantly better when combined with NB-UVB. The protocols used in this trial resulted safe and efficient.
Insights
This study found that combining VITILSI gel with narrowband UVB (NB-UVB) phototherapy significantly improved vitiligo repigmentation. Both treatments alone showed efficacy, with the combination therapy yielding the best results safely.
Area of Science:
- Dermatology
- Immunology
- Photomedicine
Background:
- Vitiligo is a chronic autoimmune skin condition affecting 1% globally, with limited effective treatments.
- Current vitiligo therapies often yield unsatisfactory results, necessitating research into innovative and safe interventions.
Purpose of the Study:
- To evaluate and compare the efficacy and safety of different treatment protocols for vitiligo lesions.
- To assess the repigmentation effects of VITILSI gel and narrowband ultraviolet B (NB-UVB) phototherapy, individually and in combination.
Main Methods:
- Four randomized groups (10 patients each) with vitiligo (8-14% skin surface area) were treated for 8 weeks.
- Interventions included NB-UVB phototherapy, VITILSI gel, combination therapy, and placebo.
- Treatment efficacy was measured by planimetry comparing baseline and post-treatment photographs.
Main Results:
- The combination therapy (VITILSI gel + NB-UVB) achieved 41% pigment area increase.
- NB-UVB alone resulted in 28% increase, while VITILSI gel alone showed 19% increase.
- The placebo group showed no repigmentation; all protocols were safe with no dropouts.
Conclusions:
- VITILSI gel monotherapy can induce repigmentation in vitiligo lesions.
- Combining VITILSI gel with NB-UVB phototherapy significantly enhances treatment outcomes for vitiligo.
- The evaluated treatment protocols are safe and effective for managing vitiligo.
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