Photodynamic Therapy of Actinic Keratoses With Alacare® | NCT01571336

Studies
Photodynamic Therapy of Actinic Keratoses With Alacare®

NCT01571336

Sponsor

photonamic GmbH & Co. KG

Status

Completed

Last Update Posted

Sep 27, 2016Estimated

Enrollment

388Actual

Phase

Not provided

Conditions

Actinic Keratosis

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

May 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Apr 3, 2012

First Submission Date that Met QC Criteria

Apr 3, 2012

First Posted Date

Apr 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2016

Last Update Posted Date

Sep 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to collect data on the frequency of SCCs in the Alacare®-treated area during an interval of two years after Alacare®-PDT.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

388Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of SCCs in areas treated with Alacare®-PDT		Two years after Alacare®-PDT

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent
Patients with 3 to 6 mild AK lesions on the hairless areas of the head and face which were treated with Alacare®-PDT according to the SPC

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Community sample

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Radny, MD	Dermatological group practice, Charlottenstraße 12, D-88045 Friedrichshafen, Germany	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinisches Zentrum Bonn Friedensplatz		Bonn		53111	Germany
Hautarztpraxis Prof. Kurzen

Condition Browse Module

MeSH Terms

ID	Term
D055623	Keratosis, Actinic

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D007642	Keratosis
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided