NCT04007159

To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess irritant or allergic response of 3 developmental cosmetic facial products following a conventional human repeated insult patch test methodology for 6 weeks.

Detailed description

A randomized, single blind (evaluator), single-center, Human Repeat Insult Patch Test (HRIPT) study in healthy adult participants aged 18 to 65 years to evaluate the cutaneous irritation and contact sensitization potential of 3 cosmetic facial skincare products. The participants will undergo repeated cutaneous application of semi-occlusive patch of 3 cosmetic facial skincare products and a reference product as a negative control (saline solution). HRIPT is a long standing, standard method to determine whether exposure to a topical product will elicit a cutaneous (dermal) irritant or allergic response (sensitization) under exaggerated (occluded) conditions. Screening of the participants will be performed at Visit 1 (i.e. from Day 0 to Day 14). The study will progress in 3-phases: Induction phase, Rest Phase and Challenge Phase. The Induction phase will continue for 3 consecutive weeks (Visit 2 to Visit 10); at visit 2, the area for patch application will be designated between the scapula and waistline, away from the spinal mid-line. A controlled amount (0.02 milliliters per centimeters square \[mL/cm\^2\]) of each study product will be randomly assigned within the patch system of each participant into the appropriate separate cell (3 cells for each of the test products and 1 cell for the saline solution). Each patch will remain in place for 48 (± 4) hours on weekdays and 72 (± 4) hours on weekend. Induction phase will be followed by 2-week (Visit 11) Rest phase; where there will be no product or patch applications. Rest phase is further followed by Challenge phase at week 6 (Visit 12 to Visit 15) in which a naïve area of the skin will be selected and a new patch with each of the cells filled with study products will be applied. After 48 (±4) hours of patch application, participants will return to the site, the patch will be removed, and subsequent test-site evaluations will be performed.

Conditions

• Skin Care

Interventions

Type	Name	Description
OTHER	Serum	Participants will be topically applied serum to the dorsum, under a semi-occlusive patch (0.02 milliliters per centimeters square \[mL/cm\^2\] of serum in an individual cell of patch)
OTHER	Lotion	Participants will be topically applied lotion to the dorsum, under a semi-occlusive patch (0.02mL/cm\^2 of lotion in an individual cell of patch)
OTHER	Cream	Participants will be topically applied cream to the dorsum, under a semi-occlusive patch (0.02mL/cm\^2 of cream in an individual cell of patch)
OTHER	Normal Saline	Participants will be topically applied normal saline to the dorsum, under a semi-occlusive patch (0.02mL/cm\^2 of normal saline in an individual cell of patch)

Timeline

• Start date: 2019-08-30
• Primary completion: 2019-11-29
• Completion: 2019-11-29
• First posted: 2019-07-05
• Last updated: 2020-12-10
• Results posted: 2020-12-10

Locations

1 site across 1 country: Brazil