NCT03573076

Brief Summary

This study investigates a non-ablative fractional thulium laser and a radio-frequency microneedling device as pre-treatment for combination photodynamic therapy in treatment of photoaged skin and actinic keratoses.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 10, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2018

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

June 6, 2018

Last Update Submit

July 8, 2020

Conditions

Photodamaged Skin

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement of photodamage

    5-point categorial scale of photodamage severity, measuring changes in skin texture, pigmentation, telangiectasia, and wrinkles. Scores are 0, 1, 2, 3, and 4, for none, mild, moderate, severe, and very severe, respectively. A reduction in score from initial scoring to post-treatment is desirable.

    12 weeks

Secondary Outcomes (6)

  • Treatment effect on actinic keratoses

    12 weeks

  • Severity of local skin reactions

    7 days

  • Presence of perceived pain during treatment

    0 days

  • Cosmetic results

    12 weeks

  • Protoporphyrin IX (PpIX) fluorescence uptake

    0 days

  • +1 more secondary outcomes

Study Arms (5)

Thulium laser + photodynamic therapy

EXPERIMENTAL

Non-ablative Thulium laser (NAFL) + Photodynamic therapy combination treatment

Combination Product: Photodynamic therapyDevice: Non-ablative Thulium laser (NAFL)

RF microneedles + photodynamic therapy

EXPERIMENTAL

Radio-frequency microneedles (RF-MN) + Photodynamic therapy combination treatment

Combination Product: Photodynamic therapyDevice: Radio-frequency microneedles (RF-MN)

Non-ablative Thulium laser

ACTIVE COMPARATOR

Non-ablative Thulium laser (NAFL) single treatment

Device: Non-ablative Thulium laser (NAFL)

RF microneedles

ACTIVE COMPARATOR

Radio-frequency microneedles (RF-MN) single treatment

Device: Radio-frequency microneedles (RF-MN)

Control

NO INTERVENTION

Control receiving no intervention

Interventions

Photodynamic therapyCOMBINATION_PRODUCT

Photodynamic therapy with Methyl Aminolevulinate creme and red light.

RF microneedles + photodynamic therapyThulium laser + photodynamic therapy
Non-ablative Thulium laser (NAFL)DEVICE

Non-ablative Thulium laser (NAFL).

Non-ablative Thulium laserThulium laser + photodynamic therapy
Radio-frequency microneedles (RF-MN)DEVICE

Radio-frequency microneedles (RF-MN).

RF microneedlesRF microneedles + photodynamic therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Décolleté with chronic field-change photodamaged skin.
  • Area with visually homogenous photodamage.
  • Provide informed written consent.

You may not qualify if:

  • Treatment of actinic keratoses in the décolleté area within the last 30 days.
  • Porphyria.
  • 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.
  • Allergies against Metvix creme solution, peanuts, or soy.
  • Considered unable to follow the study protocol, e.g. alcohol dependence syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg University Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Interventions

Photochemotherapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Merete Haedersdal, MD

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Physician Consultant

Study Record Dates

First Submitted

June 6, 2018

First Posted

June 29, 2018

Study Start

September 10, 2018

Primary Completion

December 18, 2018

Study Completion

December 18, 2018

Last Updated

July 10, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)