NCT05123911

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Investigational Shampoo	Parent/LAR will bathe the child participant with the investigational shampoo at least 3 times a week for up to 28 days.
OTHER	Investigational Conditioner	Parent/LAR will bathe the child participant with the investigational conditioner at least 3 times a week for up to 28 days.
OTHER	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.

Timeline

• Start date: 2021-11-13
• Primary completion: 2022-01-20
• Completion: 2022-03-18
• First posted: 2021-11-17
• Last updated: 2023-02-14

Locations

1 site across 1 country: Brazil