A 96 Hour Patch Test Study Using Health Human Volunteers to Assess the Skin Irritation Potential of 11 Topically Applied Formulations

NCT04942496 Phase 4 UNKNOWN

This study is an evaluation of the irritation potential of 9 test products and 2 control materials applied to the backs of at least 44 volunteer human subjects over the course of a 96-hour period to determine and compare irritation scores. Subjects will be required to complete a 7-day pre-test conditioning period prior to the test period. Finn Chambers® on Scanpor® will be used to apply each test material to a designated site on the skin of the parascapular region of the upper back every 24 hours for 96 hours. The sites will be evaluated visually prior to the first patch application and immediately following each patch removal. Instrument measurements of transepidermal water loss (TEWL) will also be performed prior to the first patch application and will start between 15 to 30 minutes, following removal of each patch.

Details

Lead sponsor	Molnlycke Health Care AB
Phase	Phase 4
Status	UNKNOWN
Enrolment	44
Start date	2021-06
Completion	2021-07

Conditions

• Skin Irritancy Potential

Interventions

• Chlorhexidine Gluconate
• Hibi Universal Bathing System
• 0.1% SLS
• Distilled Water

Primary outcomes

• Visual Evaluation of Skin Condition — assessed every 24 hours for a total of 96 hours
  The grading scale for skin condition is from 0-7 (0 - no evidence of irritation and 7-a strong reaction spreading beyond the test site) Reapplication stopped for any grade above 3.

Countries

United States