Multicenter, randomised, double-blind clinical trial on the efficacy and safety of medicinal products containing Diclofenac in patients with actinic keratosis

Dermapharm AG0 个研究点开始时间: 2014年6月3日最近更新: 2016年3月14日

适应症

试验速览

暂无简介。

•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

•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

发起方