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Pigment-Tan-Safety Study of a Light-based Home Device for Hair Removal in Adult Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01763723
First Posted: January 9, 2013
Last Update Posted: July 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christina Haak, Bispebjerg Hospital
  Purpose

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.


Condition Intervention
Healthy Device: IPL-home use device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Further study details as provided by Christina Haak, Bispebjerg Hospital:

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 ]
    Redness, edema, pigment changes, texture changes, blisters and crusting


Secondary Outcome Measures:
  • Pain [ Time Frame: Immediately after IPL exposure (approx. 2 min) ]

Other Outcome Measures:
  • mRNA expression of pigment markers [ Time Frame: 16-24 hrs after the first IPL exposure ]

Enrollment: 21
Study Start Date: April 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, over 18 years, no childbearing potential, signed informed consent, no moles,tattoos, freckles or scars in the test-area, skin type II-IV

Exclusion Criteria:

  • disease in test-area, prior treatment to IPL, taking drugs interfering with the immune system
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763723


Locations
Denmark
Bispebjerg Hospital
Copenhagen, Bispebjerg, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
  More Information

Responsible Party: Christina Haak, MD., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01763723     History of Changes
Other Study ID Numbers: H-1-2012-025
First Submitted: December 20, 2012
First Posted: January 9, 2013
Last Update Posted: July 31, 2015
Last Verified: July 2015

Keywords provided by Christina Haak, Bispebjerg Hospital:
Intense pulsed light,
UV-exposure,
skin type,
safety,
pigment,
home-use
subjects