Treatment of sun-damaged skin in the chest region with lasers, microneedles, and light-based options

Phase 1

• Conditions: Photodamaged skin in the décolleté; MedDRA version: 20.0 Level: LLT Classification code 10065944 Term: Photodamaged skin System Organ Class: 100000004858; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2018-000189-12-DK
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-25
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

* > 18 years of age.
* Décolleté with chronic field-change photodamaged skin.
* An area with visually homogenous photodamage.
* Provide informed written consent.
* Fertile women must provide a negative U-hCG pregnancy test at the time of inclusion, and use safe anticontraceptive during the entire study period, e.g. oral hormonal contraceptives, intrauterine devices, subdermal implantation, or hormonal vaginal ring.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* Actinic keratoses treatment to the décolleté area within the last 30 days.
* Porphyria diagnoses.
* Pregnant or nursing women.
* Skin cancer (invasive, in situ), keratoacanthoma, or other infiltrating tumors in the study area.
* Known tendencies to produce hypertrophic scarring or keloids.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified