Pulsed Dye Laser in Treating Superficial Basal Cell Carci... | NCT02125669

Studies
Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

NCT02125669

Sponsor

Hautklinik Darmstadt

Status

Completed

Last Update Posted

Apr 29, 2014Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Basal Cell Carcinoma

Interventions

Laser treatment
SHAM-Treatment

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

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

Nov 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Apr 13, 2014

First Submission Date that Met QC Criteria

Apr 27, 2014

First Posted Date

Apr 29, 2014Estimated

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

Apr 27, 2014

Last Update Posted Date

Apr 29, 2014Estimated

Name	Class
University Medicine Greifswald	OTHER

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

Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking due to inconsistent design of available studies. The purpose of this study is to evaluate the PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low risk anatomical sites in an evidence based study setting.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laser Treatment	Active Comparator	Pulsed dye laser 595nm	Procedure: Laser treatment
SHAM Treatment	Sham Comparator	using the pulsed dye laser (PDL) laser without releasing a pulse	Device: SHAM-Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser treatment	Procedure	Pulsed dye laser 595nm	Laser Treatment
SHAM-Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complete response		9 months

Secondary Outcomes

Measure	Description	Time Frame
patients satisfaction	questionnaire	9 months
side effects	questionnaire	9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histologically confirmed unpigmented sBCC on the trunk and extremities
maximal tumour diameter 30 mm

Exclusion Criteria:

Fitzpatrick skin type >III
pregnancy
previous BCC treatment within 4 weeks
coagulation disorders
photo sensitizing medication
any indication of poor compliance

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maurizio Podda, Dr.	Hautklinik Darmstadt	Principal Investigator
Syrus Karsai, Dr.	Hautklinik Darmstadt	Study Director
Heiko Friedl	Hautklinik Darmstadt	Study Chair

Locations

Not provided

Type	Date	Date Unknown
Release	Aug 24, 2015
Reset	Sep 21, 2015

Submission Tracking

Estimated Results First Submitted Date

Aug 24, 2015

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 24, 2015			Sep 21, 2015

Condition Browse Module

MeSH Terms

ID	Term
D002280	Carcinoma, Basal Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053685	Laser Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided