Association of Laser and Microneedling in Female Baldness.

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-76vccv
• Date of registration: 20/12/2018
• Prospective Registration: Yes
• Primary sponsor: Universidade Nove de Julho
• Public title: Association of Laser and Microneedling in Female Baldness.
• Scientific title: Association Fotobiomodulation and Microagulhamento Hair Loss in Female Pattern (FPHL): clinical study, randomized, double-blind
• Date of first enrolment: 11/02/2019
• Recruitment status: Not yet recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-76vccv
• Study type: Intervention
• Study design: Clinical trial of a randomized-controlled, parallel, double-blind, three-arm treatment trial
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: SUZANA Polonca da Silveira
• Affiliation: Universidade Nove de Julho

• Name: Suzana Polonca da Silveira
• Affiliation: Universidade Nove de Julho

Key inclusion & exclusion criteria

Inclusion criteria: This study will be conducted in women; aged between 18 and 60 years; who present the female capillary fall; telogen effluvium profile; and androgenetic alopecia; Women with capillary rarefaction; Great hair loss in the last five years; gradually in the last year; they are able to perform no chemical procedure for the period of 3 months.
Exclusion criteria: Scalp scarring; wear wigs; use appliqués that cause weight on the stem; use drugs continuously as anti-inflammatories; anxiolytics; antifungals; hormonal inhibitors; Have fungal or inflammatory conditions; women undergoing hormonal gynecological treatment; Uncontrolled chronic diseases such as Arterial Hypertension; diabetes; Participants unable to understand and sign the TCLE.

Age minimum: 18Y
Age maximum: 60Y
Gender: F

Health Condition(s) or Problem(s) studied

Androgenic alopecia; Telogen effluvium

L65.0

Intervention(s)

E02.774

Device

All patients will have their scalp anesthetized with 5% lidocaine and sanitized with 2% chlorhexidine antiseptic and will receive protection in the eye area.
Data collection will be done before the first procedure, in the middle and at the end of the 36 phototherapy session.
Group 1: Microamination and sham photobiomodulation - 22 patients will receive 36 sham photobiomodulation sessions and 3 effective microinjection sessions totaling 3 months of treatment.
Group 2: Shou Photobiomodulation and Microaggregation - 22 patients will receive during the treatment 36 sessions of photobiomodulation and 3 effective sessions of electronic microagulation totaling 3 months of treatment.
Group 3: Microaggregation and Photobiomodulation Association - 22 patients will receive during the treatment 36 sessions of photobiomodulation and 3 effective sessions of electronic microagulation, totaling 3 months of treatment.

E07.612

Primary Outcome(s)

Expected outcome 1: As a primary end point, it is expected to identify if there is an increase in yarn density (number of yarns per area in cm2) when combining Photoboomodulation with red laser 660 nm and Microagulation in Female Pattern Capillary Loss (FPHL) by means of tricoscopy dinolite equipment and global photography, measurements will be taken before, in the middle and after the 36 treatment sessions.

Secondary Outcome(s)

Expected outcome 3: As expected, the increase in capillary hair growth rate (mm / day) is expected to occur when photobiomodulation with red laser 660 nm and Microaggregation in Female Pattern Capillary Loss (FPHL) is associated with the dynamite equipment and of global photography, measurements will be taken before, in the middle and after the 36 treatment sessions.

Expected outcome 2: As a secondary endpoint, hair fiber density (n / cm2) quantification is expected to be improved when photobiomodulation is combined with red laser 660 nm and Microaggregation in female hair loss pattern (FPHL) through triscopy equipment dynolite and global photography, measurements will be taken before, in the middle and after the 36 treatment sessions.

Expected outcome 4: As a secondary endpoint, it is expected to show an improvement in the Anagena / Telogen ratio when it is associated with Red Laser Photobiomodulation 660 nm and Microaggregation in Female Capillary Loss (FPHL), through the dinolite equipment and global photography, measurements will be performed before, in the middle and after the 36 treatment sessions.

Source(s) of Monetary Support

Universidade Nove de Julho

Secondary Sponsor(s)

Universidade Nove de Julho