NCT00308854

Brief Summary

The aim of this study is to investigate whether PD P 506 A-PDT is effective in treating mild to moderate AK lesions located on the head.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

7 active sites

Status
completed

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, 2006

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 11, 2008

Status Verified

April 1, 2008

Enrollment Period

1.4 years

First QC Date

March 29, 2006

Last Update Submit

April 10, 2008

Conditions

Actinic Keratosis

Keywords

AKPDT

Outcome Measures

Primary Outcomes (1)

  • Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after PDT

    12 weeks

Secondary Outcomes (4)

  • CCR on patient basis 12 weeks, 6, 9 and 12 months after PDT

    12 months

  • CCR of treated actinic keratosis lesions 6, 9 and 12 months after PDT

    12 months

  • Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy

    12 months

  • Satisfaction and independent cosmetic rating of the cleared study lesions by patient and investigator in case of successful clearance and no recurrence of the lesion

    12 months

Study Arms (2)

1

ACTIVE COMPARATOR

PD P 506 A-PDT

Procedure: Photodynamic Therapy

2

PLACEBO COMPARATOR

Placebo-PDT

Procedure: Photodynamic Therapy

Interventions

Photodynamic TherapyPROCEDURE
12

Eligibility Criteria

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

You may qualify if:

  • Written informed consent
  • Caucasian patients
  • Diagnosis of actinic keratosis (AK) with at least three locally separated lesions located on head and/or face (hairless areas)
  • Selected AK study lesions have clearly defined margins and are mild to moderate
  • The distance between the study lesion borders is \> 1.0 cm
  • Maximum diameter of each study lesion is 1.8 cm
  • Skin sun sensitivity type I to IV according to Fitzpatrick

You may not qualify if:

  • PDT Non-responder
  • Pre-treatment of the AK lesions eligible for study procedures with pharmaceuticals approved for the treatment of AK during the 4 weeks preceding PDT
  • Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding PDT with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
  • Pre-treatment with hypericin during the 2 weeks preceding PDT
  • Treatment with systemic retinoids during the 3 months preceding PDT
  • Treatment with cytostatics or radiation during the 3 months preceding PDT
  • Female patients of childbearing potential
  • Patients with clinically relevant suppression of the immune system
  • Diagnosis of Porphyria
  • Skin diseases that might interfere with response evaluation of study PDT
  • Skin sun sensitivity type V or VI according to Fitzpatrick
  • Known intolerance to one or more of the ingredients of the study medication
  • Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
  • Suspected lack of compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Praxis Dr. Popp Dipl.-Med. Weber

Augsburg, 86179, Germany

Location

Dermatologisches Zentrum Berlin

Berlin, 14129, Germany

Location

Praxisklinik Professor Dr. Uwe Reinhold

Bonn, 53225, Germany

Location

Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin

Frankfurt a.M., 60590, Germany

Location

SciDerm

Hamburg, 20354, Germany

Location

Dermatologisches Ambulatorium Hamburg-Alstertal

Hamburg, 22391, Germany

Location

Gemeinschaftspraxis Dres. Scholz/Sebastian/Schilling

Mahlow, 15831, 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 Officials

  • Axel Hauschild, Professor MD

    Christian-Albrechts-Universität zu Kiel, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 29, 2006

First Posted

March 30, 2006

Study Start

March 1, 2006

Primary Completion

August 1, 2007

Study Completion

December 1, 2007

Last Updated

April 11, 2008

Record last verified: 2008-04

Locations

DE(7)