The role of photobiomodulation when associated with microneedling in female pattern hair loss: A randomized, double blind, parallel group, three arm, clinical study protocol

ABSTRACT: The female hair loss pattern was originally described as a synonym for androgenetic alopecia. It has been defined as progressive miniaturizations of the hair follicles, with a great impact on the quality of life of affected patients, causing significant psychosocial limitations. It was recently proven that photobiomodulation is a safe and effective way to treat the different types of hair loss. It was also known that microneedling is a minimally invasive dermatological procedure that is applied to a wide range of dermatological conditions, including androgenic alopecia, telogen effluvium, as well as other facial and bodily conditions. GOAL: The aim of this study is to verify if there is an increase in the capillary density of strands of hair, when combining 660 nm red laser photobiomodulation and microneedling in addressing female pattern hair loss (FPHL). METHODS: There will be 66 patients divided into 3 treatment groups. G1: microneedling and 660 nm red laser photobiomodulation sham; G2: 660 nm red laser photobiomodulation and microneedling sham; G3: microneedling and 660 nm red laser photobiomodulation. The treatment will consist in 36 sessions, 3 times a week for 3 consecutive months, with an insertion of microneedling every 30 days. The patients and the researchers will be blinded. The patients will be evaluated before, during, and after the treatments, by digital photography and the trichoscopy method (dermoscopic imaging of the scalp and hair). EXPECTED RESULTS: It is expected that differences will be found in the growth rates of a strand of hair in mm/d, in the density of a strand of hair in n/cm(2), in the diameter of a strand of hair, as well as in the anagen/telogen ratio. ETHICS AND DISSEMINATION: This protocol was approved by the Research Ethics Committee of the Nove de Julho University, São Paulo, Brazil, on the date of November 28, 2018 (CAAE: 01381718.0.0000.5511 - Acceptance Number: 3044061). This trial has been registered with the Brazilian Registry of Clinical Trials (REBEC TRIAL RBR-76VCCV). This study is not yet recruiting. Issue date: February 20, 2019.