Pigment-Tan-Safety Study of a Light-based Home Device for Hair Removal in Adult Subjects
This studies was designed to investigate the importance of skin type and UV-exposure on side effects after exposure to an Intense Pulsed Light Home-use device.
21 healthy subjects will receive 8 UV-exposures on one buttock and subsequently three weekly IPL-exposures.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
- Changes in skin reaction development [ Time Frame: Immediately after, 1 hr after, 16-24 hrs after, 1 week and 4 weeks after IPL exposure ] [ Designated as safety issue: Yes ]Redness, edema, pigment changes, texture changes, blisters and crusting
- Pain [ Time Frame: Immediately after IPL exposure (approx. 2 min) ] [ Designated as safety issue: Yes ]
- mRNA expression of pigment markers [ Time Frame: 16-24 hrs after the first IPL exposure ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2012|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: IPL after UV-exposure
8 UV-exposures followed by 3 weekly IPL exposures
Device: IPL-home use device
A light based home use device for hair removal
Twenty-one healthy subjects will be exposed to UV-exposures 8 times over 3 weeks on a test-area (4 x 6cm) on one buttock to induce pigmentation. This will be followed by 3 weekly IPL (intense pulsed light) exposures. At 24 hours after the first IPL exposure, biopsies will be excised from the buttocks of the subjects (4 each).The skin will be evaluated after IPL exposure for: skin reactions, pain and mRNA expression of two pigment markers. Follow-up visits is planned at 1 and 4 weeks after the third and final IPL exposure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763723
|Copenhagen, Bispebjerg, Denmark, 2400|