Efficacy and safety of 308-nm Excimer lamp combined with Tacrolimus 0.1% ointment vs Tacrolimus 0.1% ointment as monotherapy in treating children with limited vitiligo: a randomized controlled trial

Abstract

Objective

This study aims to assess the efficacy and safety of combining the 308-nm Excimer lamp with Tacrolimus 0.1% ointment, compared to Tacrolimus 0.1% ointment monotherapy, for treating pediatric vitiligo involving less than 10% of the body surface area.

Methods

Fifty pediatric patients with vitiligo were randomly assigned to two groups. Group A received Tacrolimus 0.1% ointment twice daily and Excimer light at 308-nm twice weekly, while Group B received Tacrolimus 0.1% ointment alone, administered twice daily. Repigmentation percentages were evaluated after 30, 90, and 180 days using the rule of nine.

Results

Group A exhibited a significant improvement in repigmentation, increasing from 10% after one month to 65% after six months. In contrast, Group B observed an increase from 10% to 30% over the same timeframe. The efficacy of the treatment was significantly higher in Group A at both the 3-month and 6-month follow-up points (p-value < .001). Moreover, Group A achieved notably higher repigmentation rates in the face, trunk, and lower limbs.

Conclusion

The combination of Tacrolimus and the 308-nm excimer lamp yielded superior repigmentation results compared to Tacrolimus monotherapy in pediatric vitiligo patients. This combined approach may offer an effective new treatment protocol for pediatric vitiligo.

Keywords:

• Excimer light
• pediatric
• treatment
• vitiligo

Clinical trial registration:

• The study is registered at clinicaltrials.gov under the identifier NCT06035614

Acknowledgment

The study was approved and supported by the Deanship of Research at Jordan University of Science & Technology. We would like to thank Clarteis SAS France and The Medical Distributor Ltd., Jordan for their Support in Supplying the Exciplex device (Excimer Device) and the Tacrolimus 0.1% Ointment.

Authors contributions

Conceptualization, D.S., F.Q., J.M., Methodology, D.S., S.B., A.F., Formal Analysis S.B., A.F., Data collection D.S., F.Q., J.M., O.T., D.Sa., Resources D.S., F.Q., J.M., A.T., D.Sa., A.A., M.C., Writing original manuscript D.S., F.Q., J.M., S.B., A.F., O.T., D.Sa., A.A., M.C., Review & Editing D.S., F.Q., J.M., S.B., A.F., O.T., D.Sa., A. A., M.C. Supervision of study conduct D.S., F.Q., Project administration and funding D.S., F.Q., A.A.

Disclosure statement

No financial or non-financial benefits have been received or will be received from any party related directly or indirectly to the subject of this article.

Data availability statement

Data used in the article are available on request from the corresponding author.

Additional information

Funding

The study was supported by a research grant from deanship of research at Jordan University of Science and Technology, Grant number [20220638].