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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00204542

Enrollment

418

Registered

2005-09-20

Start date

2005-06-30

Completion date

2010-12-31

Last updated

2011-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Photosensitivity Disorders

Keywords

actinic keratosis, diclofenac sodium

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.

Interventions

DRUGDiclofenac

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Histologically controlled complete clearance of the actinic keratosis	6 weeks after end of treatment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026