Title : The efficacy and safety of micro-needling combined with tacrolimus versus tacrolimus monotherapy for vitiligo treatment: A systematic review and meta-analysis
Background: Vitiligo is a common disfiguring autoimmune disease that negatively impacts patients’ quality of life. Tacrolimus is a topical immunomodulator medication that has been used successfully in treating vitiligo; however, based on recent studies, combination of topical tacrolimus with micro-needling suggests improved technique for drug delivery through stratum corneum.
Objectives: The aim of this systematic review was to assess the efficacy and safety of micro-needling combined with Tacrolimus versus Tacrolimus monotherapy in treating vitiligo.
Materials & Methods: We searched Medline, Embase, and CENTRAL. We included randomized controlled trials (RCTs) that compared micro-needling combined with Tacrolimus versus Tacrolimus monotherapy for treating individuals diagnosed with vitiligo. We sought to evaluate the following outcomes: the 5-grade re-pigmentation scale or Physician's Global Assessment (PGA), histopathological assessment, and adverse events. The risk ratio (RR) was used to represent dichotomous outcomes whereas Odds ratio (OR) used for adverse events, and the data were pooled using the inverse variance weighting method.
Results: A total of 5 RCTs that enrolled 158 participants were deemed eligible. Administration of micro-needling combined with tacrolimus were significantly more efficacious than tacrolimus monotherapy in achieving improved re-pigmentation on PGA with a rate 75-100% (RR= 1.97, 95% CI: 1.35 to 2.86). Similarly, micro-needling combined with Tacrolimus has significantly increased the positive melanoblasts in histopathological assessment (RR= 2.11, 95% CI: 1.31 to 3.39). Regarding adverse events, micro-needling combined with Tacrolimus did not exhibit any significant difference than tacrolimus monotherapy (OR= 1.72, 95% CI: 0.10 to 29.36).
Conclusions: This meta-analysis demonstrated that even though micro-needling combined with Tacrolimus is an innovative approach, it could be a promising modality as it showed a clinically and statistically substantial improvement in re-pigmentation of vitiligo sites with acceptable tolerability and safety profile.
Audience Take Away Notes:
- Presenting a systematic review and meta-analysis to the audience will help to establish a clinical judgment about the assessed treatment (micro-needling combined with tacrolimus to treat vitiligo).
- Treating local and stable vitiligo can be difficult to achieve as the lesions characterize by its resistance to re-pigmentation. Presenting the efficacy of additional and novel modality could help the audience during their clinics.
- As a lot of new modalities too treat vitiligo are emerging, providing an evidence-based medicine research will help the faculty to incorporate our results and compare them with other modalities to treat vitiligo in their future research.
- The presented treatment is Tacrolimus which undergoes the calcineurin inhibitors category and they are available and affordable to the patients. Also, the micro needling can be adjusted according to the patient’s convenience as it can be applied at clinics or home-based derma rollers.
- Systematic review and meta-analysis of randomized clinical trials are considered level 1A of evidence according to Oxford Centre for Evidence-Based Medicine. Also, our results have high level of evidence according to GRADE criteria (Grading of Recommendation, Assessment, Development, and Evaluations) which is the most adopted tool for grading the quality of evidence over 100 organizations.
- List all other benefits.
- Specify the most beneficial dosage for the treatment.
- Clarify the possible adverse events.
- Compare our results with previous conducted research.
- Proposed recommendation for future research.