EUCTR2014-001621-33-DE
Active, not recruiting
Not Applicable
Multicenter, randomised, double-blind clinical trial on the efficacy and safety of medicinal products containing Diclofenac in patients with actinic keratosis
ConditionsActinic keratosisMedDRA version: 17.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsSolaraze 3% Gel
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Actinic keratosis
- Sponsor
- Dermapharm AG
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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