Clinical trial NCT05945979: Evaluation of the Efficacy of a New Supplement for Hair and Nails - in Vitro, Clinical, Subjective and Instrumental Study
Official title: Avaliação da eficácia de um Novo Suplemento Alimentar Para Cabelos e Unhas- Estudo in Vitro, clínico, Subjetivo e Instrumental
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Loss
Nails, Ingrown
Keywords: capillary density
strengthening
hair loss
Lead sponsor: Farmoquimica S.A.
Sponsor class: INDUSTRY
Collaborators: name: Kosmoscience Ciência e Tecnologia Cosmética Ltda
First posted: 2023-07-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Phototype (Fitzpatrick): I to VI.
* Have intact skin in the test region: scalp.
* Present a clinical diagnosis of telogen effluvium.
* Agree to adhere to the study procedures and requirements: study time, returns (D-3, D0, D45, D48,D90 and D93) to the laboratory to carry out the study procedures, administration of the product research, fill the use diary, fill the perceived efficacy questionnaire, carrying out the collection of hair samples (hair cut, close to the scalp - beginning of the study and after 90 days), not change hair habits during the study period.
* Agree not to carry out chemical hair treatments (hair coloring, straightening, among others) and/or treatment to control/reduce hair loss and/or dandruff, among others, until the end of the study (90 days).
* Agree with the procedure for collecting hair samples: trichogram and hair cut, close to the leather hairy.
* Agree to administer 01 capsule/day of the investigational product. Present a minimum length of hair (3 cm) to carry out the procedure for collecting samples of hair
* Present hair and brittleness for at least 3 months before the start of the study.
* Signature of the Free and Informed Consent Term (TCLE).

Exclusion Criteria:

* Pregnancy
* During the course of the study, the subject develops symptoms of COVID-19, such as: fever (temperature above 37.5°C), cough; dyspnoea (difficulty breathing characterized by rapid, short breaths, usually associated with heart or lung disease); myalgia (muscle pain); upper respiratory symptoms; fatigue and more rarely, gastrointestinal symptoms.
* Appearance of disease that requires the use of medications prohibited in this protocol: use of corticoids and anti-inflammatories for a period longer than 15 days and/or in high doses (above 1mg/kg).
* Use of immunosuppressants during the study period.
* Use of Vitamin A or its derivatives and other vitamins and minerals.
* Beginning or changing hormone treatments after signing the TCLE.
* Swallowing difficulty: dysphagia.
* Presence of dermatoses or active skin lesions (local and/or disseminated) in the study region.
* Hypersensitivity reactions (allergic reactions, irritation or feelings of discomfort) caused by actives or excipients from the investigational product.
* Vaccine use during the study period.
* Diagnosis of diabetes or nephropathies during the study period.

Primary outcomes:
measure: Evaluate efficacy of a power supplement in reducing hair loss throgh thichogram analysis
timeFrame: Day 93
Secondary outcomes:
measure: Analysis of the biological cycle of hair growth- Trichogram
timeFrame: Three days before the beginning of product intake, Day 45 and Day 90
measure: Evaluation of hair growth kinetics- Phototrichogram
timeFrame: Three days before the beginning of product intake, Day 0, Day 45, Day 48, Day 90 and Day 93
measure: Monitoring of hair growth by photographic documentation
timeFrame: Day 0, Day 45 and Day 90
measure: Evaluation of the mechanical strength of the hair structure using EMIC DL 500
timeFrame: Three days before the beginning of product intake and Day 90
measure: Subjective efficacy of the participants by questionnaire
timeFrame: Day 45 and Day 90
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Kosmoscience Ciência e Tecnologia Cosmética Ltda
state: São Paulo
Study officials:
References: