Double-blind, randomized, clinical trial to compare the efficacy and safety of diclofenc 3% gel vs. Solaraze 3% gel vs. vehicle for the treatment of patients with actinic keratosis.

• Conditions: actinic keratosis; MedDRA version: 14.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-003317-41-DE
• Lead Sponsor: Dermapharm AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-01
• Last Update Posted: 28 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) immunocompetent men or women, 18 years or older
2) written consent form
3) diagnosis: actinic keratosis
4) at least five (5) and no more than ten (10) clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions, each at least 4 mm in diameter, contained within a 25-cm² treatment area located on the face or bald scalp
5) women of child bearing potential: use of a highly effective method of contraception during the whole course of the study
6) women: negative pregnancy test prior to study start
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, sunburn or other possible confounding skin conditions in or near the treatment area
2) use within six months prior to randomization of oral retinoids
3) use within one month prior to randomization of immunomodulators or immunosuppressive therapies, interferon, oral corticosteroids or cytotoxic drugs
4) use within six months prior to randomization on the face or bald scalp of chemical peel, dermabrasion, laser abrasion, PUVA therapy, or UVB therapy
5) use within one month prior to randomization on the face or bald scalp of cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision, topical 5-fluorouracil, topical corticosteroids, topical diclofenac, topical imiquimod, topical retinoids, or other treatment for actinic keratosis
6) known allergy or hypersensitivity to diclofenac or other excipients in one of the test products
7) known hypersensitivity reactions like asthma, rhinitis or urticaria to acetyl salicylic acid or other NSAIDs in the past
8) active gastrointestinal ulceration or bleeding
9) severe renal or hepatic impairment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the efficacy and safety of a new diclofenac 3% gel formulation vs. the originator Solaraze (licensed) vs. vehicle in patients with actinic keratosis;Secondary Objective: The following parameters are defined as secondary in the study protocol:<br>Course of the cumulative lesion number score (CLNS) between beginning of treatment (day 0) and final examination or early termination.<br>Evaluation of the global improvement by the investigator (IGII) and by the patient (PGII) during the whole study course.<br>Proportion of patients with the IGII rating cured at final examination.;Primary end point(s): The primary endpoint of the study is the proportion of patients in the per protocol population with treatment success (100% clearance of all AK lesions within the treatment area) at the final examination (30 days after completion of 90 days of treatment).;Timepoint(s) of evaluation of this end point: Start of therapy (day 0) and end of study (day 120, visit 5).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Course of the cumulative lesion number score (CLNS) between beginning of treatment (day 0) and final examination or early termination.<br>2) Evaluation of the global improvement by the investigator (IGII) and by the patient (PGII) during the whole study course.<br>3) Proportion of patients with the IGII rating cured at final examination.<br>4) Evaluation of the tolerability of the treatment by the investigator and the patient<br>5) safety laboratory<br>6) assessment of adverse events in the course of the study<br>;Timepoint(s) of evaluation of this end point: 1) at every visit<br>2), 4), 6) every visit from visit 2 on<br>3) last visit (visit 5)<br>5) begin (visit 1) and end of therapy (visit 4)<br>