2.1. Patients and Study Design
RECRUITMENT, RECRUITMENT
The study protocol was scrutinized and approved by the local ethics committee (EC of Berbekov’s State Medical University, Nal’chik, Russia; 16 December 2021 protocol). The recruitment and clinical research were carried out in two centers—Dermatology Department, Berbekov’s State Medical University and in the Center for Innovative Biotechnological Investigations NANOLAB (CIBI-NANOLAB, Trichology unit). Informed consent was obtained from all participants prior to their enrollment and data collection. Collected data included: personal and anamnestic records, trichomicrophotographs of the scalp, scalp skin sebum, and plucked hairs. Recruitment, treatment, biological material collection, and the use of personal data were conducted in accord with the Helsinki Declaration on ethics in human experimentations.The tested cohort consisted of 154 adults (of both sexes aged from 21 to 71 years), who were clinically diagnosed as having either diffuse (The control cohort consisted of 27 adults of both sexes recruited from the laboratory staff and the University students, who kindly agreed to donate plucked hairs for biochemical tests.Eligibility criteria: (a) Study design: All participants were randomly placed into 3 groups: Group 1 experimental (Regular use of the products for 14 weeks;Avoid any other product with similar intended use;In the case of any side effects, they were instructed to immediately discontinue the products and consult a dermatologist.Visits and analyses: There were 2 visits to the principal investigators: the first visit (0 weeks) was at the beginning of the study, when a person received the products and was instructed about their use. The trichomicrophotographs were taken for the first time. Several hairs from different parts of the scalp (frontal, occipital, and two temporal areas) were plucked and a scalp skin sebum sample was collected from the same scalp areas and stored for the further analyses. The second visit (14 weeks) was at the cessation of the trial, when the dermatologists/trichologists expressed their independent opinion on the treatment efficacy by filling in the questionnaire, microphotography of the scalp was taken for the second time, several hairs were plucked, and the scalp sebum was collected as described above.