Evaluation of the Efficacy of a New Supplement for Hair and Nails - in Vitro, Clinical, Subjective and Instrumental Study

NCT05945979 | Completed

• 1 other identifier: FQM166-20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Hair Loss; Nails, Ingrown

Keywords

capillary density; strengthening; hair loss

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 93

Secondary Outcomes (5)

• Analysis of the biological cycle of hair growth- Trichogram

  Three days before the beginning of product intake, Day 45 and Day 90

• Evaluation of hair growth kinetics- Phototrichogram

  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

  Day 0, Day 45 and Day 90

• Evaluation of the mechanical strength of the hair structure using EMIC DL 500

  Three days before the beginning of product intake and Day 90

• Subjective efficacy of the participants by questionnaire

  Day 45 and Day 90

Study Arms (1)

A power supplement with biotin

EXPERIMENTAL

40 participants using the product for 90 days. Aims to evaluate the clinical, subjective and instrumental usage

Dietary Supplement: A power supplement with biotin

Interventions

A power supplement with biotin DIETARY_SUPPLEMENT

A power dietary supplement containing aminoacids and vitamins

A power supplement with biotin

Eligibility Criteria

• Age: 25 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Farmoquimica S.A.: lead
• Kosmoscience Ciência e Tecnologia Cosmética Ltda: collaborator

Study Sites (1)

Kosmoscience Ciência e Tecnologia Cosmética Ltda

Valinhos, São Paulo, 13270-180, Brazil

Location

MeSH Terms

Conditions

Alopecia; Nails, Ingrown

Interventions

Biotin

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Nail Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: July 14, 2023
• Study Start: March 7, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 14, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: D93

Locations

BR (1)