NCT00204542

Brief Summary

Topical treatment of mild to moderate actinic keratosis located on the face and head with Solaraze® is known to be a safe and efficient treatment option. However, it is unclear if an expansion of the treatment period to 6 months will increase the rate of complete responses. Therefore the investigators will evaluate the efficacy and safety of the treatment of actinic keratosis with Solaraze® applied twice daily to the face and head over 3 or 6 months of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
418

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_4

Geographic Reach
1 country

4 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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 19, 2011

Status Verified

March 1, 2009

Enrollment Period

3.8 years

First QC Date

September 13, 2005

Last Update Submit

August 18, 2011

Conditions

Photosensitivity Disorders

Keywords

actinic keratosisdiclofenac sodium

Outcome Measures

Primary Outcomes (1)

  • Histologically controlled complete clearance of the actinic keratosis

    6 weeks after end of treatment

Study Arms (2)

A

ACTIVE COMPARATOR

Solaraze(R) 2x/day for 3 months

Drug: Diclofenac

B

ACTIVE COMPARATOR

Solaraze(R) 2x/day for 6 months

Drug: Diclofenac

Interventions

DiclofenacDRUG

Solaraze® (Diclofenac sodium) 2x/day topical for 3 months

A

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Visible and histologically proven actinic keratosis
  • Prepared and able to give written informed consent
  • ≥ 18 -80 years of age
  • Prepared and comply with all study requirements, including the following: application of gel on the treatment area twice a day, 5 / 7 clinic visits during the prestudy, treatment, posttreatment, and follow-up period
  • Pre- and posttreatment biopsy for histological confirmation (of clearance) of actinic keratosis diagnosis

You may not qualify if:

  • Data of clinically significant, unstable, cardiovascular or haematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or diseases
  • Known allergies to any excipient in the study drug
  • Any dermatological disease and/or condition in the treatment or surrounding area (3 cm distances from treatment area) that may be exacerbated by treatment with diclofenac or cause difficulty with examination
  • Active chemical dependency or alcoholism, as assessed by the investigator
  • Currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 30 days
  • Received topical treatment at the treatment area with imiquimod or 5-FU within a time period of 1 month
  • Invasive tumours within the treatment area, e.g. merkel cell carcinoma, squamous cell carcinoma, basal cell carcinoma, the latter is accepted if completely surgically removed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Klinik fuer Dermatologie, Venerologie und Allergologie der Charite

Berlin, 10117, Germany

Location

Dept. of Dermatology

Freiburg im Breisgau, 79104, Germany

Location

Praxis Priv.-Doz. Dr. med. Dirschka

Wuppertal, Germany

Location

Related Publications (2)

  • Nelson C, Rigel D, Smith S, Swanson N, Wolf J. Phase IV, open-label assessment of the treatment of actinic keratosis with 3.0% diclofenac sodium topical gel (Solaraze). J Drugs Dermatol. 2004 Jul-Aug;3(4):401-7.

    PMID: 15303784BACKGROUND

  • Rivers JK. Topical 3% diclofenac in 2.5% hyaluronan gel for the treatment of actinic keratoses. Skin Therapy Lett. 2004 Jan;9(1):1-3.

    PMID: 14716439BACKGROUND

Related Links

MeSH Terms

Conditions

Photosensitivity DisordersKeratosis, Actinic

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPrecancerous ConditionsNeoplasmsKeratosis

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Claus Garbe, MD

    Skin Cancer Program, Department of Dermatology, University Hospital Tübingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

June 1, 2005

Primary Completion

March 1, 2009

Study Completion

December 1, 2010

Last Updated

August 19, 2011

Record last verified: 2009-03

Locations

DE(4)