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

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763723
• Other study ID #: H-1-2012-025
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: July 30, 2015
• Start date: April 2012
• Est. completion date: October 2013

Study information

• Verified date: July 2015
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• IPL-home use device
A light based home use device for hair removal

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Bispebjerg

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mRNA expression of pigment markers		16-24 hrs after the first IPL exposure	Yes
Primary	Changes in skin reaction development	Redness, edema, pigment changes, texture changes, blisters and crusting	Immediately after, 1 hr after, 16-24 hrs after, 1 week and 4 weeks after IPL exposure	Yes
Secondary	Pain		Immediately after IPL exposure (approx. 2 min)	Yes