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A pilot study evaluating the efficacy of the 204 LEDs helmet in men with initial vertex hair loss

A pilot study evaluating the efficacy of the 204 LEDs helmet in men with initial vertex Androgenetic Alopecia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6dn3mm
Enrollment
Unknown
Registered
2019-07-04
Start date
2019-05-06
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic alopecia

Interventions

Ten volunteers with clinical and tricoscopic diagnosis of androgenic alopecia grade III vertex and IV of Hamilton-Norwood will be selected. The volunteers will undergo medical anamnesis and physical e
In area "A", located more proximal to the nasal dorsum, 3 points will be demarcated with a minimum distance of 5 mm, with sterile ink
In area "B", following the most distal midline of the nasal dorsum in the transition line between the bald area and the less bald area, another area of interest will be demarcated. The volunteers sele
Device

Sponsors

Every Eletroeletrônica Importação e Exportação LTDA – EPP
Lead Sponsor
Every Eletroeletrônica Importação e Exportação LTDA – EPP
Collaborator

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1 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 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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactLeonardo Spagnol Abraham

Hospital Regional da Asa Norte

leosabraham@gmail.com55 61 3244-6734

Outcome results

None listed

Source: REBEC (via WHO ICTRP)