Treatment Study for Actinic Cheilitis Comparing Imiquimod... | NCT00849992

Studies
Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy

NCT00849992

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

May 15, 2017Actual

Enrollment

53Actual

Phase

Phase 4

Conditions

Actinic Cheilitis

Interventions

Imiquimod 5%
Photodynamic therapy

Countries

Norway

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

May 2017

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

Mar 2009Actual

Primary Completion Date

Mar 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Feb 23, 2009

First Submission Date that Met QC Criteria

Feb 23, 2009

First Posted Date

Feb 24, 2009Estimated

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

May 12, 2017

Last Update Posted Date

May 15, 2017Actual

Name	Class
St. Olavs Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data, histology (skin analysis), epidemiological data and follow-up data.

Detailed Description

Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis. Histological, efficacy, epidemiological and clinical data will be collected.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Imiquimod 5%	Other	Patients randomized to this arm will receive treatment with imiquimod 5%	Drug: Imiquimod 5%
Photodynamic therapy	Other	Patients will be randomized to receive photodynamic therapy twice at a 2 week interval to the affected area.	Procedure: Photodynamic therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imiquimod 5%	Drug	Imiquimod 5% cream used three days a week for 4 weeks	Imiquimod 5%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical and pathological complete cure rates.		3 and 12 months after therapy

Secondary Outcomes

Measure	Description	Time Frame
clinical, safety, epidemiological and histopathological data	Through collecting patient data and post-treatment biopsy	post-treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical findings of actinic cheilitis.
Histological findings demonstrating epithelial changes equal to or greater than mild epithelial dysplasia in severity (mild - moderate - severe).
Age above 18.
Willingness to take post-treatment biopsy.

Exclusion Criteria:

Disorders predisposing to photosensitivity (porphyria, SLE).
Pregnancy or nursing.
Known allergy to any excipients in the study creams.
prescribed topical retinoids, 5-fluorouracil, cryodestruction, surgical excision and curettage.

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
Stein H Sundstrøm, PhD	St. Olavs Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Olavs Hospital		Trondheim		7006	Norway

Condition Browse Module

MeSH Terms

ID	Term
C535669	Actinic cheilitis

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077271	Imiquimod
D010778	Photochemotherapy

Ancestor Terms

ID	Term
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided