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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Christina Haak, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01763723
First received: December 20, 2012
Last updated: January 8, 2013
Last verified: January 2013
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Further study details as provided by 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 ] [ 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 ]

Estimated Enrollment: 21
Study Start Date: April 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763723

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

No publications provided

Responsible Party: Christina Haak, MD., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01763723     History of Changes
Other Study ID Numbers: H-1-2012-025
Study First Received: December 20, 2012
Last Updated: January 8, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on November 25, 2014