Comparative clinical study on the efficacy and safety of an already approved medicinal product for treatment of actinic keratosis (disease/impairment of the skin by UV light) with a new medicinal product that contains the same active substance and a product without the active substance (vehicle)

• Conditions: Actinic keratosis; MedDRA version: 17.0Level: 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: EUCTR2014-001621-33-DE
• Lead Sponsor: Dermapharm AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-03
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

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

Inclusion Criteria

1. Immunocompetent women or men at least 18 years of age
2. Informed consent (signed)
3. Diagnosis: actinic keratosis
4. Area requiring treatment of about 50 cm2 in total located on the face and/or (hairless) scalp. The area should be chosen that a continuous surface forms.
5. Within the area requiring treatment: not less than 7 distinct lesions that should be identifiable with the following characteristics: clinical mild to moderate degree, at least 4 mm in diameter, nonhypertrophic, not severe hyperkeratotic
6. Women of child bearing potential: use of a highly effective method of contraception during the whole duration of the clinical trial
7. Women: negative pregnancy test prior to start of treatment

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 426
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Presence of the following skin diseases at the treatment area: carcinoma (e.g. basal cell carcinoma, squamous cell carcinoma), eczema like atopic dermatitis, psoriasis vulgaris, Rosacea papulopustulosa or other possible confounding conditions
2. Hypertrophic, severe hyperkeratotic actinic keratosis lesions within the treatment area that have to be characterized as severe actinic keratosis
3. Systemic retinoid therapy within six months prior to treatment start
4. Systemic therapy with immunomodulators, immunosuppressive drugs, interferon, glucocorticoids or cytotoxic drugs within 28 days prior to treatment start
5. Therapies or use of chemical peel, dermabrasion, PUVA or UVB therapy at the treatment area within six months prior to treatment start
6. Cryodestruction, curettage, laser abrasion, photodynamic therapy, 5-fluorouracil, diclofenac, imiquimod, retinoid or other treatment of the actinic keratosis or topical glucocorticoid treatment at the treatment area 28 days prior to treatment start
7. Known allergy or hypersensitivity to diclofenac or one of the other excipient of the test products
8. Pseudoallergic reactions like asthma, rhinitis or urticarial to acetyl salicylic acid or other NSAIDs in medical history
9. Presence of gastrointestinal ulceration or bleeding
10. 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. <br>See also E5 (endpoints);Secondary Objective: See E5 (endpoints);Primary end point(s): The primary endpoint of the study is the proportion of patients in the per protocol population with reduction of the Target Lesion Number Score (TLNS) of = 75% at the final examination;Timepoint(s) of evaluation of this end point: Start of therapy (day 0) and end of study (day 120)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Proportion of patients with a TLNS reduction of = 75% at the end of treatment<br>- Changes of the severity of the target lesions in comparison to the situation before Treatment <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<br>- 100 % clearance of all AK lesions at the final examination (CLNS =0) and proportion of patients with 100 % reduction of the TLNS;Timepoint(s) of evaluation of this end point: Different, depending on the end Point, see E.5.2