Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Photosensitivity Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Solaraze(R) 2x/day for 3 months

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

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

B

Solaraze(R) 2x/day for 6 months

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

Solaraze® (Diclofenac sodium) 2x/day topical for 6 months

Interventions

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Diclofenac

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

Intervention Type DRUG

Diclofenac

Solaraze® (Diclofenac sodium) 2x/day topical for 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No