## Protocol Section
### Identification Module
**NCT ID:** NCT05945979

**Brief Title:** 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

#### Organization Study ID Info
**ID:** FQM166-20
#### Organization
**Class:** INDUSTRY
**Full Name:** Farmoquimica S.A.
### Status Module
#### Completion Date
**Date:** 2022-06-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-14

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-06-01

**Type:** ACTUAL

#### Start Date
**Date:** 2022-03-07

**Type:** ACTUAL

**Status Verified Date:** 2023-06

#### Study First Post Date
**Date:** 2023-07-14
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-26
**Study First Submit QC Date:** 2023-07-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Kosmoscience Ciência e Tecnologia Cosmética Ltda

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Farmoquimica S.A.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Hair Loss

- Nails, Ingrown

**Keywords:**

- capillary density

- strengthening

- hair loss

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Dietary Supplement: A power supplement with biotin

**Label:** A power supplement with biotin

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A power supplement with biotin

**Description:** A power dietary supplement containing aminoacids and vitamins

**Name:** A power supplement with biotin

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Evaluate efficacy of a power supplement in reducing hair loss throgh thichogram analysis

**Time Frame:** Day 93

#### Secondary Outcomes

**Description:** 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.

**Measure:** Analysis of the biological cycle of hair growth- Trichogram

**Time Frame:** Three days before the beginning of product intake, Day 45 and Day 90

**Description:** 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.

**Measure:** Evaluation of hair growth kinetics- Phototrichogram

**Time Frame:** Three days before the beginning of product intake, Day 0, Day 45, Day 48, Day 90 and Day 93

**Description:** 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.

**Measure:** Monitoring of hair growth by photographic documentation

**Time Frame:** Day 0, Day 45 and Day 90

**Description:** 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.

**Measure:** Evaluation of the mechanical strength of the hair structure using EMIC DL 500

**Time Frame:** Three days before the beginning of product intake and Day 90

**Description:** 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.

**Measure:** Subjective efficacy of the participants by questionnaire

**Time Frame:** Day 45 and Day 90

### Eligibility Module

**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.

**Gender Based:** True

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 25 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Valinhos

**Country:** Brazil

**Facility:** Kosmoscience Ciência e Tecnologia Cosmética Ltda

**State:** São Paulo

**Zip:** 13270-180

### IPD Sharing Statement Module

**Info Types:**

- STUDY_PROTOCOL

- SAP

- CSR

**IPD Sharing:** YES

**Time Frame:** D93

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007039

- Term: Hypotrichosis

- ID: D000006201

- Term: Hair Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000009260

- Term: Nail Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3846

- Name: Alopecia

- Relevance: HIGH

- As Found: Hair Loss

- ID: M3847

- Name: Alopecia Areata

- Relevance: HIGH

- As Found: Hair Loss

- ID: M12214

- Name: Nails, Ingrown

- Relevance: HIGH

- As Found: Nails, Ingrown

- ID: M10089

- Name: Hypotrichosis

- Relevance: LOW

- As Found: Unknown

- ID: M9293

- Name: Hair Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M12211

- Name: Nail Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000505

- Term: Alopecia

- ID: D000000506

- Term: Alopecia Areata

- ID: D000009263

- Term: Nails, Ingrown

### Intervention Browse Module - Ancestors

- ID: D000014803

- Term: Vitamin B Complex

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M4992

- Name: Biotin

- Relevance: HIGH

- As Found: Perianal

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: T439

- Name: Biotin

- Relevance: HIGH

- As Found: Perianal

- ID: T473

- Name: Vitamin B7

- Relevance: LOW

- As Found: Unknown

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001710

- Term: Biotin

### Misc Info Module

- Version Holder: 2024-05-24
