A Study of 3 Investigational Products on the Microbiome and Scalp Attributes in Children With Curly Hair
NCT ID: NCT05123911
Last Updated: 2023-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2021-11-13
2022-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Product Kit: Shampoo, Conditioner and Combining Cream (Investigational Products [IPs])
The 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.
Investigational Shampoo
Parent/LAR will bathe the child participant with the investigational shampoo at least 3 times a week for up to 28 days.
Investigational Conditioner
Parent/LAR will bathe the child participant with the investigational conditioner at least 3 times a week for up to 28 days.
Investigational Combing Cream
Parent/LAR will apply investigational combining cream to wet and previously moistened hair at least 3 times a week for up to 28 days.
Interventions
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Investigational Shampoo
Parent/LAR will bathe the child participant with the investigational shampoo at least 3 times a week for up to 28 days.
Investigational Conditioner
Parent/LAR will bathe the child participant with the investigational conditioner at least 3 times a week for up to 28 days.
Investigational Combing Cream
Parent/LAR will apply investigational combining cream to wet and previously moistened hair at least 3 times a week for up to 28 days.
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
Exclusion Criteria
* 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
* 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
* 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
3 Years
6 Years
ALL
Yes
Sponsors
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Johnson & Johnson Consumer Inc. (J&JCI)
INDUSTRY
Responsible Party
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Principal Investigators
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Mariane M Mosca, Bsc
Role: PRINCIPAL_INVESTIGATOR
Allergisa Pesquisa Dermato-Cosmética Ltda
Locations
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Allergisa Pesquisa Dermato-Cosmética LTDA
Campinas, São Paulo, Brazil
Countries
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References
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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.
International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50. No abstract available.
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.
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.
Related Links
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Other Identifiers
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CCSSKB004136
Identifier Type: OTHER
Identifier Source: secondary_id
CCSSKB004136
Identifier Type: -
Identifier Source: org_study_id
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