Efficacy and Tolerability of Microneedling on Facial and Neck Fine Lines and Wrinkles of Male and Female Subjects
With advancements in device technology, non-surgical and minimally invasive options have gained increasing popularity for improving the appearance of skin fine lines and wrinkles. While laser resurfacing and peeling agents remain the gold standard, several alternative treatments are under investigation. Microneedling is a minimally invasive technique in which several small needles are applied to the skin in a repetitive motion, resulting in controlled microinjury. This process may stimulate the tissue rejuvenation with the formation of new tissue and blood vessels. This study used a microneedling device currently FDA-approved to improve the appearance of acne scars in adults aged 22 and older. The purpose of this study was to assess the efficacy and tolerability of the microneedling device on men and women with fine lines and wrinkles of the face and neck.
Methods/Technique:
This single-center, prospective study enrolled 35 male and female subjects between the ages of 44 and 65. Each subject received a microneedling (Bellus Medical) treatment over the entire face and neck once every month for four months (four treatments total) at microneedle depths between 1.0 and 2.5mm. Subjects followed up one month and three months post-treatment. At every visit, both standard photography and VISIA Complexion Analysis were performed. Additional non-invasive skin measurements, namely, high-resolution ultrasonography, optical coherence tomography (OCT) 3D imaging, transepidermal water loss (TEWL) and BTC 2000, were taken. Microbiopsies, 0.33mm in diameter, were collected near the left alar base prior to the first treatment, before the fourth treatment and three months post-treatment to evaluate the effect of microneedling on tissue histology and gene expression. Subjects completed the Subject Global Aesthetic Improvement Scale and a satisfaction questionnaire based on a live assessment of his or her face compared to pre-treatment photographs.
Results/Complications:
32 subjects (93.75% female, 6.25% male) completed four treatments and the one- and three-month post-treatment follow-up visits. One patient was withdrawn from the study due to non-compliance and two subjects were lost to follow-up. All subjects experienced pinpoint bleeding during treatment and moderate erythema post-treatment. However, these reactions are anticipated and resolved within days of treatment.
Dermal and epidermal density in the cheek was increased 101.86% and 19.28%, respectively, at three months post-treatment (dermal density- p<0.001, epidermal density- p=0.0078). Elasticity in the face increased 28.2% from baseline at three months post-treatment (p= 0.0039). In the face, attenuation coefficient increased 15.65% and 17.33% from baseline one month (p<0.001) and three months (p=0.0012) post-treatment, respectively. In the neck, only a 7.99% increase at one month post-treatment was statistically significant (p= 0.014). Blood flow was significantly increased in the face and neck 100 uM below the skin surface at three months post-treatment, but significantly decreased at a depth of 500 uM.
At three months post-treatment, the relative intensity of dermal collagen type 3 was increased nearly three-fold compared to baseline (p=0.02). Additionally, 7 of 12 samples extracted at the three-month follow-up visit showed an increase in dermal muscle formation on trichrome staining. TNF-alpha expression was increased immediately prior to the final microneedling treatment (p=0.01), but no statistically significant change was noted three months post-treatment.
At three months post-treatment, 71.9% of subjects saw an improvement in at least one of the following parameters in the treatment area- number of fine lines and wrinkles, size of fine lines and wrinkles, size of pores, skin texture, skin tone, or skin clearness. When asked three months post-treatment, 65.6% of subjects would recommend microneedling to others.
Conclusion:
The results from this study illustrate the safety and tolerability of four treatments using a microneedling device to improve the appearance of fine lines and wrinkles on the face and neck. Both non-invasive skin measurements and microbiopsy data demonstrated changes in skin architecture in both the face and neck after treatment. The treatments were well-tolerated by all subjects, with only slight discomfort reported by a few patients, particularly when treating over the nose and forehead. There were no adverse events related to the device or treatment during the course of the study. Additionally, subject satisfaction was high, and a majority of participants would recommend this treatment to others. Further studies will evaluate the feasibility and efficacy of these treatments on other body regions, including the dorsal hand.