Pigment-Tan-Safety Study of a Light-based Home Device for Hair Removal in Adult Subjects
This study has been completed.
Information provided by (Responsible Party):
Christina Haak, Bispebjerg Hospital
First received: December 20, 2012
Last updated: July 30, 2015
Last verified: July 2015
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.
Device: IPL-home use device
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- Pain [ Time Frame: Immediately after IPL exposure (approx. 2 min) ] [ Designated as safety issue: Yes ]
Other Outcome Measures:
- mRNA expression of pigment markers [ Time Frame: 16-24 hrs after the first IPL exposure ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Healthy, over 18 years, no childbearing potential, signed informed consent, no moles,tattoos, freckles or scars in the test-area, skin type II-IV
- disease in test-area, prior treatment to IPL, taking drugs interfering with the immune system
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01763723
|Copenhagen, Bispebjerg, Denmark, 2400 |
||Christina Haak, MD., Bispebjerg Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 20, 2012
||July 30, 2015
||Denmark: The Danish National Committee on Biomedical Research Ethics
Keywords provided by Bispebjerg Hospital:
ClinicalTrials.gov processed this record on July 25, 2016
Intense pulsed light,