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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01763723

Enrollment

Registered

2013-01-09

Start date

2012-04-30

Completion date

2013-10-31

Last updated

2015-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Intense pulsed light,, UV-exposure,, skin type,, safety,, pigment,, home-use, subjects

Brief summary

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.

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.

Interventions

DEVICEIPL-home use device

A light based home use device for hair removal

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in skin reaction development	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

Measure	Time frame
Pain	Immediately after IPL exposure (approx. 2 min)

Other

Measure	Time frame
mRNA expression of pigment markers	16-24 hrs after the first IPL exposure

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026