Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT03183518
Brief Summary:
To evaluate the skin irritation and sensitization potential of a cosmetic facial product, under exaggerated conditions of use with controlled product application and under supervision of a dermatologist.
Detailed Description:
In this three-phase phototoxicity-photosensitisation (PT-PA) study, the test material and a positive control are applied under a semi-occlusive patch to the upper back of each subject. The first phase of the study is an Induction Phase; a controlled amount of each product is applied under a semi-occlusive patch. The patch will remain on the skin for 24 (±2) hours during this phase. Following patch removal the patch site will be exposed to ultraviolet - A (UVA) radiation and re-assessed 24 hours later prior to re-application of another semi-occlusive patch (with both the products) to the same site. The Induction phase will last 3 weeks. After a subject completes the Induction Phase they will enter a Rest Phase of 2 weeks duration, during which no patches will be applied. After the Rest Phase, subjects will return to the clinical site for the Challenge Phase. In the Challenge phase two test patches will be applied to virgin skin areas on each subjects' upper back for 24 hours. Following removal of both patches, one of the Challenge patch test sites will be exposed to UVA radiation. Both Challenge patch test sites will be assessed up until 72 (±2) hours later.
Study:
NCT03183518
Study Brief:
Protocol Section:
NCT03183518