NCT03233009

To Investigate Primary Irritation Potential of Four Skin Serum Products on Human Subjects Assessed by 24 Hour Patch Test

A Human Subject 24 Hour Patch Test to Assess the Irritation Potential of Four Skin Serum Products

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To assess the irritation potential of four prototype daily defense serum formulations after 24 (± 2) hours under semi-occlusive patch application to the skin of healthy volunteers.

Detailed description

This is an evaluator (single) blind, test site randomized and intra-subject comparison patch test study to evaluate the cutaneous irritation potential of four experimental daily defense serum formulations, including a saline solution as a negative control.

Conditions

• Skin Care

Interventions

Type	Name	Description
OTHER	Experimental Daily Defense Serum A	Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
OTHER	Experimental Daily Defense Serum C	Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
OTHER	Experimental Daily Defense Serum G	Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
OTHER	Experimental Daily Defense Serum N	Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
OTHER	Saline Solution Sodium Chloride	Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).

Timeline

• Start date: 2017-05-22
• Primary completion: 2017-05-26
• Completion: 2017-05-26
• First posted: 2017-07-28
• Last updated: 2019-01-16
• Results posted: 2018-09-07

Locations

2 sites across 1 country: Brazil