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.

Dermapharm AG0 sitesSeptember 1, 2011

Overview

No summary available.

Registry

who.int

Start Date

September 1, 2011

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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