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

B

Bispebjerg Hospital

Status

Completed

Conditions

Healthy

Treatments

Device: IPL-home use device

Study type

Interventional

Funder types

Other

Identifiers

NCT01763723
H-1-2012-025

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

IPL after UV-exposure
Experimental group
Description:
8 UV-exposures followed by 3 weekly IPL exposures
Treatment:
Device: IPL-home use device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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