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Biotin in the treatment of female hair loss

A 24-week randomized, prospective, triple-blinded, placebo-controlled trial investigating the efficacy of 10 mg biotin in the treatment of chronic effluvium telogen in women

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-69qq9p
Enrollment
Unknown
Registered
2020-01-29
Start date
2019-07-01
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

Telogen effluvium

Interventions

One hundred participants will be randomly randomized into two groups (block randomization, second list provided by computer program). One group will be instructed to take two 2.5 mg biotin capsules ev
Dietary supplement
G07.203.300.456

Sponsors

Paulo Ramos
Lead Sponsor
Faculdade Medicina da Universidade Estadual Paulista - UNESP
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: women between the ages of 18 and 65 who complain of increased hair loss for more than six months; daily loss of yarn equivalent to at least level 5 of the Sinclair drop scale

Exclusion criteria

Exclusion criteria: Clinical or dermatoscopic signs of alopecia areata, trichotillomania or cicatricial alopecias; anemia (hemoglobin less than 11 mg / dl), thyroid changes (TSH> 4.0 or 1.5 or <0.7 ng/dl); history of any treatment for hair loss in the last 3 months; surgery, pregnancy, febrile infectious disease or suspension of contraceptive use in the last 4 months.

Design outcomes

Primary

MeasureTime frame
Variation in anagen phase density in the target area at the 24th week of treatment. Prior to initiation of treatment (week 0), a circular template 2 cm in diameter will be placed in the occipital region. The hairs inside the template will be scraped. After two days the patients will return to perform a 10-fold increase in dermatoscopic image (DermoGenious ultra; DermoScan GmgH, Germany). As only the anagen hairs show growth, the larger strands are identified as anagen. The number of hairs will be established in an automated manner by the TrichoScan® software.17 Every procedure will be repeated after 24 weeks of treatment. the anagen phase density in the target area at the 24th week of treatment. Prior to initiation of treatment (week 0), a circular template 2 cm in diameter will be placed in the occipital region. The hairs inside the template will be scraped. After two days the patients will return to perform a 10-fold increase in dermatoscopic image (DermoGenious ultra; DermoScan GmgH, Germany). As only the anagen hairs show growth, the larger strands are identified as anagen. The number of hairs will be established in an automated manner by the TrichoScan® software. Every procedure will be repeated after 24 weeks of treatment.

Secondary

MeasureTime frame
Variation in total hair density in the target area at the 24th week of treatment: prior to full scraping of the hairs in the target area for determination of anagen density, the hairs will be scraped to a length of 2 mm. The automated counting by Trichoscan® software will be used to determine the total hair density.;Daily amount of hair loss: it will be evaluated through the visual scale presented to patients at week 0 and 24.;Hair growth rate: Hairs scraped at week 0 will be measured at week 24. The length of the hair in centimeters divided by the number of days since the scraping will determine the average growth rate.;Clinical photos evaluation: photos will be taken with digital camera (Nikon D300) at 90 and 45 degree angles with hair distributed in half under standardized lighting. The photos will be evaluated by 3 blind dermatologists regarding the treatment. Each dermatologist will compare the initial photo with that of 24 weeks and will use a 7 point comparison scale: major worsening (- 3), moderate worsening (- 2), slight worsening (- 1), no change (0), slight improvement +1), moderate improvement (+2) and great improvement (+3).;Satisfaction evaluation with treatment: at week 24 participants will be questioned about their perception of improvement / worsening of their hair according to the following criteria: brightness, resistance and volume. The response will be indicated on a scale of 1 to 5 where: 1 - major improvement; 2 - slight improvement; 3 - indifferent; 4 - slight worsening and 5 - major worsening.

Countries

Brazil

Contacts

Public ContactPaulo Ramos

Faculdade Medicina da Universidade Estadual Paulista - UNESP

dermato.paulo@gmail.com+55 (43) 3256 9898

Outcome results

None listed

Source: REBEC (via WHO ICTRP)