A unicentric, exploratory, prospective clinical an in vitro study to evaluate efficacy and safety of a Supplement in improving the quality and general aspects of hair and nails in female participants through clinical,in vitro, subjective and instrumental evaluations
A unicentric, exploratory, prospective clinical an in vitro study to evaluate efficacy and safety of a Supplement in improving the quality and general aspects of hair and nails in female participants through clinical, in vitro, subjective and instrumental evaluations. It will be necessary 40 female participants aged between 25 and 55 years old with a clinical and in vitro diagnosis of telogen effluvium presenting at least one of the following characteristics: hair loss problems caused by stress, poor diet and excess of tinctures and chemicals procedures applied to hair, and menopausal women. The participants will remain in the study for 93 days using the product. Visits will be scheduled in D-3, D0, D45, D48, D90, D93. Instrumental evaluations: Evaluated on each visit: * To analyze the biological cycle of hair growth using Trichogram test - D-3, D45, D90; * Evaluation of hair growth kinetics using phototrichogram - D-3,D0, D45, D48, D90, D93; * Evaluation of the mechanical strength of the hair structure using EMIC DL 500- D-3, D90 * Evaluation of the dermal density of the scalp using the high-frequency ultrasound- D-3, D45, D90 * Participants will respond to a subjective assessment using a questionnaire to capture a subjective efficacy- D45, D90
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A power dietary supplement containing aminoacids and vitamins
Kosmoscience Ciência e Tecnologia Cosmética Ltda
Valinhos, São Paulo, Brazil
Evaluate efficacy of a power supplement in reducing hair loss throgh thichogram analysis
Evaluate the effectiveness of the product investigational in providing reduction of hair loss through thrichogram analysis. If the ratio between anagen/telogen hairs strands is \> 4, it indicates improvement in reducing hair loss after daily and continuous use for a period of up to 90 days.
Time frame: Day 93
Analysis of the biological cycle of hair growth- Trichogram
Evaluate the phase of the biological cycle of hair growth (anagen, telogen or catagen) and determine the ratio between anagen/telogen hair strands. If the ratio between anagen/telogen hairs strands is ≤ 4, it indicates positive symptoms for androgenetic alopecia or telogen effluvium and the partipant will be included in the study.The trichogram was performed three days before the beginning of product intake, and after 45 days and 90 days of continuous use.
Time frame: Three days before the beginning of product intake, Day 45 and Day 90
Evaluation of hair growth kinetics- Phototrichogram
Evaluate the growth kinetics of hair strands after shaving a standardized area of 1 cm² of the scalp and taking images on the same day and three days after. In total, three scrapings were performed on three days before intervention, day 45 and day 90, totaling six image collections. A microscope (i-Scope USB, Moritex, JP) with a 30x lens and polarized light was used to obtain the images. In each collection, three microimages of the evaluated area on the head of each participant were recorded.
Time frame: Three days before the beginning of product intake, Day 0, Day 45, Day 48, Day 90 and Day 93
Monitoring of hair growth by photographic documentation
Evaluation of the dermal thickness of hair strands through specific software. Patients will be submitted to the Ultrascan UC 22 MHz equipment (Courage + Khazaka electronic GmbH), on day 0 and after 45 days and 90 days of continuous use of the investigational product.
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Time frame: Day 0, Day 45 and Day 90
Evaluation of the mechanical strength of the hair structure using EMIC DL 500
Evaluation of the mechanical resistance of the hair. 50 hairs strands were collected from each participant and cut with the aid of scissors to avoid possible damage to the hair shaft resulting from traction for pulling out. The test was performed three days before the beginning of product intake and after 90 days of continuous use.
Time frame: Three days before the beginning of product intake and Day 90
Subjective efficacy of the participants by questionnaire
Evaluate the perceived efficacy of the product from the participant's point of view through a subjective questionnaire after 45 days e 90 days of continuous use of the product. The questionnaire uses a 7-point scale, where 1 meaning poor and 7 means excellent.
Time frame: Day 45 and Day 90