Clinical trial NCT05123911: A Study of 3 Investigational Products on the Microbiome and Scalp Attributes in Children With Curly Hair
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2021-11-17
Enrollment: 35
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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)
* 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:

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
* 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

Primary outcomes:
measure: Change from Baseline to 28 +- 2 days in Score of Topical Tolerability of the Participant's Scalp
timeFrame: Baseline (Day 1) to 28 +- 2 days
measure: Change from Baseline to 28 +- 2 days in Score of Scalp Residue Through use of Affected Area Criteria
timeFrame: Baseline (Day 1) to 28 +- 2 days
measure: Change from Baseline to 28 +- 2 days in Score of Scalp Residue Through use of Severity Criteria
timeFrame: Baseline (Day 1) to 28 +- 2 days
measure: Change from baseline to 28 +- 2 days in Scalp Skin Barrier Evaluation
timeFrame: Baseline (Day 1) to 28 +- 2 days
measure: Change from Baseline to 28 +- 2 days in Scalp Sebumetry Evaluation
timeFrame: Baseline (Day 1) to 28 +- 2 days
measure: Change from Baseline to 28 +-2 days in Scalp Skin pH Evaluation
timeFrame: Baseline (Day 1) to Day 28 +-2 days
measure: Change from Baseline to 28 +- 2 days in Scalp Image Capture
timeFrame: Baseline (Day 1) to Day 28 +- 2 days
Secondary outcomes:
measure: Change from Baseline to 28 +- 2 days in Scalp Microbiome
timeFrame: Baseline (Day 1) and Day 28 +- 2 days
measure: Scalp Microbiome Collection and Metagenomic Analysis
timeFrame: Baseline (Day 1)
measure: Change from Baseline to 28 +- 2 days in Quality-of-life Questionnaire
timeFrame: Baseline (Day 1) and Day 28 +- 2 days
measure: Change from Baseline to 28 +- 2 days in Scalp Hydration Evaluation
timeFrame: Baseline (Day 1) and Day 28 +- 2 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa Pesquisa Dermato-Cosmética LTDA
state: São Paulo
Study officials:
affiliation: Allergisa Pesquisa Dermato-Cosmética Ltda
name: Mariane M Mosca, Bsc
role: PRINCIPAL_INVESTIGATOR
References:
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