Topical pimecrolimus 1% treatment had unsatisfactory results, while combination microneedling and topical pimecrolimus treatment showed a favorable outcome.
Although there is no cure for vitiligo, microneedling has been shown to be effective in the repigmentation of lesions and the combination of microneedling with topical treatment, such as topical pimecrolimus, may increase its effectiveness.
Led by Ali Asilian, Department of Dermatology, School of Medicine Skin Disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, a team of investigators compared the effect of topical pimecrolimus and microneedling on refractory stable vitiligo when used alone or in combination.
The team observed the combination therapy of microneedling and topical pimecrolimus 1% treatment produced more favorable overall outcomes, compared to monotherapy.
The study was a randomized clinical trial on 32 lesions from 16 patients randomly selected from patients with vitiligo who were referred to dermatology clinics in Iran between December 2019 - December 2020.
In each patient, 2 similar lesions on 2 similar limb locations are chosen for each patient and examined as a distinct entity. Lesions were assigned to Lesion A and treated with topical pimecrolimus 1% plus microneedling, while lesion B was treated with topical pimecrolimus 1% solely.
Inclusion criteria were patients between the ages of 18 - 60 years, with vitiligo lesions on their limbs, did not respond to light therapy or topical or systemic treatments, and did not have active vitiligo or new lesions within the past year.
For the follow-up, digital photography was taken at baseline and biweekly for 3 months after treatment and 6-months follow-up. Patients were evaluated using a patient satisfaction questionnaire, the dermatology quality of life index (DLQI), and repigmentation responses to treatment determined by 2 independent dermatologists.
A total of 15 objects consisting of 8 males (53.33%) and 7 females (46.66%) were followed up within the intervention.
There were no significant improvements observed in the pimecrolimus method during the treatment or follow-up periods. However, the combination of microneedling and topical pimecrolimus 1% showed a more favorable overall outcome (P <.001).
Data show combination therapy had poor recovery levels after 2 weeks of treatment and fair repigmentation reached 40% after 2 months, while 33.3% of patients showed good recovery status 3 months after treatment and excellent repigmentation appeared in 6.7% after 6 months follow-up.
In combination treatment, Friedman’s test demonstrated that a patient’s recovery status improved significantly over time (P <.001). Fisher's exact test showed that the frequency distribution of patients’ recovery level was not statistically significant after 1 month of treatment (P = .999).
Additionally, patient satisfaction with combination treatment significantly increased over time. There was a statistically significant difference in patient satisfaction at 45 days, 2 months, 75 days, 3 months, and 6 months following treatment in 2 groups.
Further, Friedman's test revealed that when microneedling and pimecrolimus were used in combination, DLQI scores decreased significantly (P = .002).
No side effects were reported in 14 patients, while no side effects were observed following the use of the microneedling device.
“Overall, our results showed the higher response rate of topical pimecrolimus plus microneedling combination versus pimecrolimus cream alone method as in terms of skin repigmentation,” investigators wrote.
The study, “Microneedling in Combination with Topical Pimecrolimus 1% versus Topical Pimecrolimus 1% for the Treatment of Refractory Stable Vitiligo: A Randomized Clinical Trial,” was published online in Dermatology Research and Practice.