A pilot study evaluating the efficacy of the 204 LEDs helmet in men with initial vertex hair loss
- Conditions
- Androgenetic alopecia
- Registration Number
- RBR-6dn3mm
- Lead Sponsor
- Every Eletroeletrônica Importação e Exportação LTDA – EPP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Male volunteers; with shaved hair or who agree to shave the hair for maximum 1 mm length in all interest areas for tricoscopy analyzes; Age between 18 and 65 years, with clinical and tricoscopic diagnosis of androgenic alopecia grade III vertex and IV of Hamilton-Norwood; who attended at the dermatology clinic of the Hospital Regional da Asa Norte”; Have signed the free and informed consent form; Have signed the authorization for use of image for research, medical publication and dissemination purposes.
Carriers of: uncompensated thyroid disease; anemia or ferritin below 20 mcg/L; FAN with titration greater than 1/320 of any pattern except nuclear fine dot pattern; VDRL with titration greater than 1/8; Carriers of other forms of non-androgenetic alopecia, such as: telogen effluvium, alopecia areata, lichen planopilaris, discoid lupus of the scalp, trichotillomania, among others; Scar at the site of the tricoscopy; Individuals with white or very light hair in color that make difficult the tricoscopic analysis and that do not accept to dye all their hair for the global and tricoscopic pictures; Individuals with hair dye allergy when necessary to use it; Individuals who are using drugs with androgenic or anti-androgenic properties, chemotherapeutic agents, finasteride or others 5-alpha-reductase inhibitors; Individuals who have performed any type of treatment for androgenetic alopecia in the last 6 months, such as finasteride, minoxidil, corticosteroids, 17-alpha-estradiol, ketoconazole, laser/LED, microneedling; Individuals who have had any flavivirus disease in the last 6 months have undergone any type of major surgery requiring anesthesia with sedation, large weight loss or other known cause of telogen effluvium; as well as at any time have undergone bariatric surgery or hair transplantation at the tricoscopy site; Individual has not used the device under study for at least 4 different days per week or if it has not been used for more than 7 consecutive days and also used more than 7 times per week.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expected outcome 1<br>2-point improvement after intervention, based on 7-point intensity scale [(-3) considerable decrease, (-2) moderate decrease, (-1) discrete decrease, (0) no change, (1) (2) moderate increase and (3) significant increase] by comparing clinical and trichoscopic images based on the evaluation of capillary density and yarn thickness. This analysis will be performed by 2 blind and experienced researchers.;Expected outcome 2<br>Increase of approximately 10-20% in the quantitative tricoscopic analysis, considering: the average number of hairs / cm2, the average thickness of the hair excluding new hairs, the accumulated thickness of all yarns and the wire-to-wire comparison of capillary thickness change .
- Secondary Outcome Measures
Name Time Method Improvement after 3 months of treatment in at least 1 point on the 7 points intensity scale [(-3) considerable decrease, (-2) moderate decrease, (-1) discrete decrease, (0) no change, (1) increase (2) moderate increase and (3) significant increase] comparing the clinical and tricoscopic images based on capillary density and the thickness of the hairs shafts. This analysis will be performed by 2 blind and experienced researchers. ;Increase of approximately of approximately 5-10% in the quantitative tricoscopic analysis, considering: the average number of hairs/cm2, the average hair thickness excluding the new hairs, the accumulated thickness of all hairs and the comparison hair to hair of the thickness change.