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| ID | Type | Description | Link |
|---|---|---|---|
| CCSSKB004136 | Other Identifier | Johnson & Johnson Consumer Inc. (J&JCI) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product Kit: Shampoo, Conditioner and Combining Cream (Investigational Products [IPs]) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Shampoo | Other | Parent/LAR will bathe the child participant with the investigational shampoo at least 3 times a week for up to 28 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (Day 1) to 28 +- 2 days |
| 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). | Baseline (Day 1) to 28 +- 2 days |
| 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). | Baseline (Day 1) to 28 +- 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
For children
For parent/LAR of participants
Exclusion Criteria:
For Children
For parent/LAR of participants
Additional exclusion criteria during Coronavirus Disease 2019 (COVID-19) pandemic
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| Name | Affiliation | Role |
|---|---|---|
| Mariane M Mosca, Bsc | Allergisa Pesquisa Dermato-Cosmética Ltda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergisa Pesquisa Dermato-Cosmética LTDA | Campinas | São Paulo | 13084791 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | 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. | ||
| Background | 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. | ||
| Background | Cortex Technology. DermaLab® Combo - technical specifications. Available on: https://cortex.dk/multi-parameter-dermalab-combo/. | ||
| Background | 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. | ||
| Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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| Investigational Conditioner | Other | 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 | Other | Parent/LAR will apply investigational combining cream to wet and previously moistened hair at least 3 times a week for up to 28 days. |
|
| 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. | Baseline (Day 1) to 28 +- 2 days |
| 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. | Baseline (Day 1) to 28 +- 2 days |
| 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. | Baseline (Day 1) to Day 28 +-2 days |
| 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. | Baseline (Day 1) to Day 28 +- 2 days |
| Baseline (Day 1) and Day 28 +- 2 days |
| 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. | Baseline (Day 1) |
| 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. | Baseline (Day 1) and Day 28 +- 2 days |
| 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. | Baseline (Day 1) and Day 28 +- 2 days |
| Background | 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. |
| 18078200 | Background | 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. |
| Background | 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. |
| Background | 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. |
| 33790324 | Background | 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. |
| Background | 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. |