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HealthyNCT05123911

A Study of 3 Investigational Products on the Microbiome and Scalp Attributes in Children With Curly Hair

A study testing Investigational Conditioner and Investigational Combing Cream in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the topical safety (tolerability/acceptability) of a kit of cosmetic products (shampoo, conditioner, and combing cream), the presence of residues on the scalp through visual assessment and image capture, the skin barrier, pH, and sebum level. Read more about this study

Who is it for?
Ages 3 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Investigational Conditioner and Investigational Combing Cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
1 siteBrazil
Study dates
13 Nov 2021to 18 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • For children
  • Female and male children participants
  • 3 to 6 years old
  • Fitzpatrick Skin Type IV to VI
  • Generally, in good health based on medical history reported by the parent/legally acceptable representative (LAR)
  • Intact skin in the test region, scalp, (except for the presence of mild seborrheic dermatitis, if applicable)
Show all 19Show fewer
  • Children participants with curly to kinky hair
  • Children participants with a minimum hair length of 5 cm (3 fingers)
  • Minors under the age of assent should be accompanied by a LAR who can read, write, speak, and understand Portuguese
  • For parent/LAR of participants
  • 18 to 65 years old
  • Generally, in good health based on medical history
  • Has presented proof of guardianship for the infant participant (that is, birth certificate along with valid Identity document [ID] of parents/LAR)
  • Able to read, write, speak, and understand Portuguese
  • Individual has signed the informed consent document (ICD) and ICID (Informed consent image document)
  • Be willing and able to participate and comply with the study that requires the use of the principal investigator (PIs) as indicated on the child throughout the study period
  • Agrees not to use the provided products on any other family member (other than the child participant) for the duration of the study
  • Agrees to bathe your child in the shower instead of the bathtub
  • Intends to complete the study and is willing and able to follow all study instructions

Who cannot join

  • For Children
  • Has known allergies or adverse reactions to common topical skincare products, including shampoo, conditioner and combing cream
  • Presents with a skin condition that may confound the study results (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema or active skin cancer)
  • Presents with primary/secondary lesions (example: scars, ulcers, vesicles) on test sites
  • Has parent/LAR reported Type 1 or Type 2 diabetes in the participant or is taking insulin or another anti-diabetic medication
  • Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including: a) Immunosuppressive or steroidal drugs within 2 months before Visit 1; b) Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; c) Antihistamines within 2 weeks before Visit 1; d) Topical or systemic antibiotics or antifungals within 30 days before Visit 1
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  • Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
  • Having had chemical treatments that transform the hair shaft (for example: straightening, hair relaxation, Et cetera [etc.])
  • Present folliculitis and/or hair loss disorders
  • Use anti-hair loss treatment for at least three months before the study start
  • Use anti-dandruff shampoos on the scalp and/or hair for at least three weeks before the study start
  • Be using or have used in the last 4 weeks long hairstyles, such as Nago braids made only on natural hair or with the addition of synthetic fiber threads (example: Kanekalon, Jumbo or wool)
  • Exposure or having been exposed in the last 7 days to the beach, swimming pool and intense sun during the study period
  • Simultaneously participating in any other clinical study
  • Be an immediate family member of the PI, Study Site, or Sponsor
  • Initiate probiotic treatment or supplementation (Culturelle, Provance, Colidis, Probioatop, Bifidobacterium, Lactobacillus, etc.) during the study
  • Change treatment with probiotics (Culturelle, Provance, Colidis, Probioatop, Bifidobacterium, Lactobacillus, etc.) if the participating child is already using them before the study begins
  • For parent/LAR of participants
  • Has known allergies or adverse reactions to common topical skincare products, including shampoo, conditioner and combing cream
  • Has reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
  • Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including: a) Immunosuppressive or steroidal drugs within 2 months before Visit 1; b) Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; c) Antihistamines within 2 weeks before Visit 1
  • Is self-reported to be pregnant or planning to become pregnant during the study
  • Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
  • Is simultaneously participating in any other clinical study
  • Is an employee/contractor or immediate family member of the PI, study site, or sponsor
  • Additional exclusion criteria during Coronavirus Disease 2019 (COVID-19) pandemic
  • History of a confirmed COVID-19 infection in the last 30 days
  • Contact with COVID-19-infected person within 14 days prior to enrollment
  • Any international travel within 14 days prior to enrollment including members in the same household
  • Participants with self-reported symptoms within the past 2 weeks: a) Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomachaches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever, or chest pain/tightness; b) Temperature greater than or equal to (>=) 38 degree Celsius (°C)/100 degree Fahrenheit (°F), measured; c) Use of fever reducers within 2 days prior to each on-site visit

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Allergisa Pesquisa Dermato-Cosmética LTDA

    Campinas, São Paulo, 13084791

Other trials in Brazil

About this study

Official title: A Single Center, Open Label, Safety in Use Clinical Study to Assess the Topical Tolerability and Influence of Routine Use of 3 Investigational Products on the Microbiome and Scalp Attributes in Children With Curly Hair

The purpose of this study is to evaluate the topical safety (tolerability/acceptability) of a kit of cosmetic products (shampoo, conditioner, and combing cream), the presence of residues on the scalp through visual assessment and image capture, the skin barrier, pH, and sebum level. All these evaluations will be performed before and after 28 plus minus (+-) 2 days of use under normal conditions, under the supervision of dermatologist and pediatrician.

Conditions
Healthy
Being tested
Investigational Shampoo, Investigational Conditioner, Investigational Combing Cream

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Investigational ShampooOther

    Parent/LAR will bathe the child participant with the investigational shampoo at least 3 times a week for up to 28 days.

  • Investigational ConditionerOther

    Parent/LAR will bathe the child participant with the investigational conditioner at least 3 times a week for up to 28 days.

  • Investigational Combing CreamOther

    Parent/LAR will apply investigational combining cream to wet and previously moistened hair at least 3 times a week for up to 28 days.

Study groups in NCT05123911
Study groupRoleWhat they receive
Product Kit: Shampoo, Conditioner and Combining Cream (Investigational Products [IPs])ExperimentalThe parents/legally acceptable representative (LAR) of the participants will receive a product kit containing the 3 investigational products (shampoo, conditioner and combining cream) and will bathe the child participant with shampoo followed by conditioner and then apply combining cream to wet and previously moistened hair at least 3 times a week for up to 28 days.
Receives: Other: Investigational Shampoo; Other: Investigational Conditioner; Other: Investigational Combing Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline to 28 +- 2 days in Score of Topical Tolerability of the Participant's Scalp

    Change from baseline to 28 +- 2 days in score of topical tolerability of the participant's scalp will be reported. Topical tolerability of investigational products (shampoo, conditioner and combining cream) will be assessed by clinical assessment of the initial condition of the participant's scalp assessed by the dermatologist based on attributes such as: itching, stinging, burning, irritation, dryness, desquamation, and erythema. The attributes will be evaluated using a 5-point scale (0=none, 1=very mild, 2=mild, 3=moderate, 4=intense).

    Measured: Baseline (Day 1) to 28 +- 2 days

  2. Change from Baseline to 28 +- 2 days in Score of Scalp Residue Through use of Affected Area Criteria

    Change from baseline to 28 +- 2 days in score of scalp residues through use of affected area criteria will be reported. Scalp residue assessment will be performed by a trained technician using the scalp dandruff counting methodology, using a pre-defined seborrheic dermatitis severity scale, in which the amount of residue will be calculated for the four quadrants of the scalp, through the rating scale for the area affected by the residue (where score of 0=less than 10 percent [%] affected area; 1=10-30% affected area; 2=30-50% affected area; 3=50-70% affected area and 4= more than 70% affected area).

    Measured: Baseline (Day 1) to 28 +- 2 days

  3. Change from Baseline to 28 +- 2 days in Score of Scalp Residue Through use of Severity Criteria

    Change from baseline to 28 +- 2 days in score of scalp residues will be reported. Scalp residue assessment will be performed by a trained technician using the scalp dandruff counting methodology, using a pre-defined seborrheic dermatitis severity scale, in which the amount of residue will be calculated for the four quadrants of the scalp, through the rating scale for residual severity (where score of 1=small flakes reminding of a white powder; 2=intermediate; 3=large flakes adhering to the scalp, appearing as an irregular surface; 4=intermediate; 5=apparently frozen flakes in the form of yellowish plaques attached to the scalp, some with evidence of exudation or erythema).

    Measured: Baseline (Day 1) to 28 +- 2 days

  4. Change from baseline to 28 +- 2 days in Scalp Skin Barrier Evaluation

    Scalp skin barrier assessment will be performed by a trained technician through instrumental measurements with the Tewameter TM Nano equipment (Courage-Khazaka Electronic GmbH). The Tewameter TM probe measures the rate of water evaporation from the skin's surface. A decrease in transepidermal water loss (TEWL) values indicates an improvement in the scalp skin barrier.

    Measured: Baseline (Day 1) to 28 +- 2 days

  5. Change from Baseline to 28 +- 2 days in Scalp Sebumetry Evaluation

    The evaluation of scalp sebumetry will be performed by a trained technician through instrumental measurements with the Sebumeter SM 815 (Courage + Khazaka Electronic GmbH) equipment. The equipment principle is based on the change of a translucent membrane that becomes progressively more transparent as it absorbs substances of a lipidic nature.

    Measured: Baseline (Day 1) to 28 +- 2 days

  6. Change from Baseline to 28 +-2 days in Scalp Skin pH Evaluation

    Scalp pHmetry evaluation will be performed by a trained technician through instrumental measurements with the Mettler Toledo S8 Seven 2 Go Portable pH equipment. As the skin, with its excretions, is almost an aqueous solution, the pH measurement evaluates an important characteristic of any aqueous solution: acidity or alkalinity. The pH value lies on a point on the scale from 0 (strongly acidic) to 14 (strongly alkaline), with the value 7 representing neutrality.

    Measured: Baseline (Day 1) to Day 28 +-2 days

  7. Change from Baseline to 28 +- 2 days in Scalp Image Capture

    The scalp image will be captured by a trained technician, through the Fotofinder equipment, for registering the possible residues found on the scalp and evaluated by a trained technician.

    Measured: Baseline (Day 1) to Day 28 +- 2 days

Secondary outcomes (4)

  1. Change from Baseline to 28 +- 2 days in Scalp Microbiome

    The scalp microbiome is composed of a group of microorganisms, including bacteria and fungi, that play an important role on the scalp. To evaluate the type and number of bacteria and fungi present on the surface of the scalp, a sample will be collected on this area using a swab. We will analyze the type and number of microorganisms before and after the investigational products (IPs) regimen. This evaluation will be done through metagenomics, a technique that allow the determination of the different types and quantity of microorganisms present in a specific area. The microbiota reads generated from each participating individual are compared against existing public databases to classify the species present and the number of times each appears in the individual's microbiome in the collected area.

    Measured: Baseline (Day 1) and Day 28 +- 2 days

  2. Scalp Microbiome Collection and Metagenomic Analysis

    The scalp microbiome is composed of a group of microorganisms, including bacteria and fungi, that play an important role on the scalp. To evaluate the type and number of bacteria and fungi present on the surface of the scalp, a sample will be collected on this area using a swab. We will analyze the type and number of microorganisms before and after the IPs regimen. This evaluation will be done though metagenomics, a technique that allows the determination of the different types and quantity of microorganisms present in a specific area. The microbiota reads generated from each participating individual are compared against existing public databases to classify the species present and the number of times each appears in the individual's microbiome in the collected area.

    Measured: Baseline (Day 1)

  3. Change from Baseline to 28 +- 2 days in Quality-of-life Questionnaire

    Parents/legally acceptable representative (LAR) of children participants will complete a questionnaire consist of 5 questions to report on the quality of life, health, and other areas of the child's life.

    Measured: Baseline (Day 1) and Day 28 +- 2 days

  4. Change from Baseline to 28 +- 2 days in Scalp Hydration Evaluation

    The scalp hydration evaluation will be performed by a trained technician through instrumental measurements with the DermaLab USB Moisture Module equipment (Cortex Technology). The equipment is based on conductance principle. The higher the conductance, more amount of water, an increase in free electrons happens, therefore, the higher the hydration of the skin. An increase in conductance values indicates an improvement in hydration.

    Measured: Baseline (Day 1) and Day 28 +- 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2021
  2. Study start13 Nov 2021
  3. Primary completion20 Jan 2022
  4. Study completion18 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05123911
Sponsor's protocol ID
CCSSKB004136
Other IDs
CCSSKB004136
Status last verified
Jan 2023
First submitted
9 Nov 2021
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Publications

  • Agência Nacional De Vigilância Sanitária. Guia para Avaliação de Segurança de Produtos Cosméticos. 2a ed., 2012. Available on <http://www.anvisa.gov.br/cosmeticos/guia/guia_cosmeticos_final_2.pdf> Accessed by: 05 Jan 2017

  • ASSOCIAÇÃO MÉDICA MUNDIAL. Declaração de Helsinque. Princípios Éticos para Pesquisa Médica Envolvendo Participantes Humanos. Available on: <http://www.wma.net/en/30publications/10policies/b3/17c.pdf>. Accessed by: 05 Jan 2017.

  • BRASIL. Ministério da Saúde. RDC nº 466, de 12 de dezembro 2012. Aprova diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos. Available on: <http://conselho.saude.gov.br/resolucoes/2012/Reso466.pdf>. Accessed by: 05 Jan 2017.

  • Cortex Technology. DermaLab® Combo - technical specifications. Available on: https://cortex.dk/multi-parameter-dermalab-combo/.

  • Courage + Khazaka electronic GmbH. Skin-pH-Meter PH 905: The Measuring Principle. Available on: <http://www.courage-khazaka.de/index.php/en/artikel-work/59-products/scientific/132-skinphmeter.

  • Courage + Khazaka electronic GmbH. Sebumeter® SM 815. The Measuring Principle. Available on: https://courage-khazaka.de/en/scientific-products/efficacy-tests/16-wissenschaftliche-produkte/alle-produkte/151-sebumeter-e.

  • Courage + Khazaka electronic GmbH. Tewameter® TM Nano. The Measuring Principle. Available on: https://courage-khazaka.de/en/scientific-products/efficacy-tests/16-wissenschaftliche-produkte/alle-produkte/157-tewameter-nano-e.

  • De la Mettrie R, Saint-Leger D, Loussouarn G, Garcel A, Porter C, Langaney A. Shape variability and classification of human hair: a worldwide approach. Hum Biol. 2007 Jun;79(3):265-81. doi: 10.1353/hub.2007.0045.

    PubMed 18078200

  • ICH HARMONIZED TRIPARTITE GUIDELINE. Guideline for Good Clinical Practice E6 (R1). International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996. Available on: <http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf>. Accessed by: 05 Jan 2017.

  • OPAS. Organização Pan-Americana de Saúde. Boas Práticas Clínicas: Documento das Américas. IV Conferência Pan-Americana para Harmonização da Regulamentação Farmacêutica, 2005. Disponível em: http://www.anvisa.gov.br/medicamentos/pesquisa/boaspraticas_americas.pdf Acesso em: 10 18 MAR ABR 2016.

  • Saxena R, Mittal P, Clavaud C, Dhakan DB, Roy N, Breton L, Misra N, Sharma VK. Longitudinal study of the scalp microbiome suggests coconut oil to enrich healthy scalp commensals. Sci Rep. 2021 Mar 31;11(1):7220. doi: 10.1038/s41598-021-86454-1.

    PubMed 33790324

  • Oliveira, A. C. S. TRANÇANDO CABELO, IDENTIDADE, ESTIGMA E CONSUMO: um estudo sobre as maneiras de consumir relacionadas à manipulação capilar de mulheres de cabelos crespos e cacheados a partir da teoria da prática. Dissertação (mestrado) - Universidade Federal de Minas Gerais, Centro de Pós-Graduação e Pesquisas em Administração (2019). Disponível em: https://repositorio.ufmg.br/bitstream/1843/30441/1/Disserta%C3%A7%C3%A3o_finalizada%20-%20Ana%20Carolina%20Soares.pdf. Acesso em: 17 SET 2021.

Questions about this trial

What is this clinical trial studying?

A study testing Investigational Conditioner and Investigational Combing Cream in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline to 28 +- 2 days in Score of Topical Tolerability of the Participant's Scalp (time frame: Baseline (Day 1) to 28 +- 2 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05123911, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.

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