NCT03175562

To Assess the Cutaneous Irritation and Sensitization Potential of a Cosmetic Facial Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Participants

A Human Repeat Insult Patch Test (HRIPT) in Healthy Subjects to Assess the Cutaneous Irritation and Sensitization Potential of a Cosmetic Facial Product

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of this clinical study is to assess the irritation and sensitisation potential of a cosmetic test product after repeated semi-occlusive patch applications to healthy human participants by following a conventional HRIPT methodology under supervision of a dermatologist.

Detailed description

The first phase of the study is an Induction Phase; a known amount of each product (test and control) is applied, under a semi-occlusive patch. Patches will remain on the skin for 48 (±2) (weekdays) or 72 (±2) (including inclusive weekends) hours during this phase. Induction phase lasts for 3 weeks. After the Induction Phase participants will enter a Rest Phase of 2 weeks duration, during which no patches are applied. After the Rest Phase, participants will return to the clinical site for the Challenge Phase. In this phase a challenge patch containing the test and control products is applied to virgin skin for 48 (±2) hours then assessed 30 minutes (maximum 1 hour) following removal, 24 (± 2) and 48 (±2) hours later.

Conditions

• Skin Care

Interventions

Type	Name	Description
OTHER	Facial micellar cleanser	Participant will have each product applied topically via semi occlusive patch, on site by the technician. Each patch will remain in place for 48 (± 2) hours on weekdays and 72 (± 2) hours on weekends.
OTHER	Saline Solution: Sodium Chloride (NaCl; 0.9%)	Participant will have each product applied topically via semi occlusive patch, on site by the technician. Each patch will remain in place for 48 (± 2) hours on weekdays and 72 (± 2) hours on weekends.

Timeline

• Start date: 2017-03-27
• Primary completion: 2017-05-19
• Completion: 2017-05-19
• First posted: 2017-06-05
• Last updated: 2019-02-15
• Results posted: 2019-02-15

Locations

1 site across 1 country: Brazil