Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT04019795
Brief Summary:
The REVIAN study is designed as a prospective, randomized, controlled, double-blind, parallel study to evaluate the efficacy and safety of the REVIAN System in male participants with androgenic alopecia. An Active modulated light therapy REVIAN System will be compared to a Placebo Comparator non-active REVIAN System in participants using the device for a daily 10-minute treatment over the course of 26-weeks. At each follow-up visit, participants will be interviewed to determine if any adverse events (AEs) were experienced since the previous follow-up visit. All participants will be required to complete self-administering scalp hair growth and life quality questionnaires at each follow-up visit. Investigators will be required to complete global assessments of scalp hair growth for each enrolled participant at each follow-up visit. Macrophotography evaluations will be performed at baseline, 8-, 16-, and 26 weeks for all participants using standard Canfield blinded reviewer. Global photographs of superior and vertex scalp will be taken by participants and by PI to be assessed by a blinded reviewer once all photos have been captured for each participant per visit.
Study:
NCT04019795
Study Brief:
Protocol Section:
NCT04019795