NCT01481155

Brief Summary

The purpose of this study is to determine whether photodynamic therapy or CO2 laser therapy is superior in the treatment of actinic keratoses with respect to efficacy and side effects.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

December 8, 2011

Status Verified

December 1, 2011

Enrollment Period

9 months

First QC Date

November 24, 2011

Last Update Submit

December 7, 2011

Conditions

Actinic Keratosis

Keywords

actinic keratosisfield cancerisation

Outcome Measures

Primary Outcomes (1)

  • Number of actinic keratoses 3 months after treatment

    3 months

Secondary Outcomes (2)

  • Histologic features

    1 month after therapy

  • Epidermal thickness in optical coherence tomography

    1 month after therapy

Interventions

ablative CO2 laser therapyPROCEDURE

CO2 laser therapy

photodynamic therapyPROCEDURE

Treatment with 5-ALA cream, application time at least 4 h, red light radiation with 76 J/cm²

Eligibility Criteria

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

You may qualify if:

  • men and women with clinical and histological diagnosed, symmetrical distributed actinic keratoses
  • at least 2 actinic keratoses, on each of both treatment areas at least one
  • Patients must be 18 years or older.

You may not qualify if:

  • Age 17 years or younger
  • lack of patient's informed consent for any of the two treatments
  • contraindication for Co2 therapy or for photodynamic therapy
  • skin infection in the treatment area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Venereology and Allergology, Ruhr University

Bochum, 44791, Germany

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Nina Scola, consultant in Ruhr University of Bochum

Study Record Dates

First Submitted

November 24, 2011

First Posted

November 29, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Last Updated

December 8, 2011

Record last verified: 2011-12

Locations

DE(1)