EUCTR2012-002529-30-DEActive, not recruitingNot Applicable
Three-armed, randomized, double-blind dose-finding trial on efficiency and safety of Ibuprofen 5% gel, Ibuprofen 7,5% gel und Ibuprofen 10% gel in patients with actinic keratosis Olsen grade I/II
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Dolorgiet GmbH & Co. KG
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Age: = 18 years
- •- Gender: male and female
- •- Actinic Keratosis (Olsen grade I/II)
- •- at least 5 aktinic keratoses on the scalp, forehead, face, extremities, and/ or decolleté
- •- no treatment of the actinic keratoses within the previous 3 months before inclusion in the study
- •- histologic confirmation of the diagnosis actinic keratosis by biopsy
- •- good general condition
- •- normal laboratory values (creatinine, urea, GOT, GPT, GGT, LDH) and blood count at study start not higher than 1.5 x upper norm limit
- •- Female patients must be tested negative for pregnancy before inclusion in the trial. During the trial, female patients have to apply a generally accepted form of birth control (i.e. oral estrogen- and gestagen-containing contraceptives; estrogen containing skin plaster/ tape, hormone implant, hormone contraceptive coil, sterilisation; sexual abstinence) or being post-menopausal for at least 2 years.
- •- Willing and able to participate in the screening and all trial specific procedures in compliance with the protocol
- •- Signed written informed consent
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
Exclusion Criteria
- •- Known allergy against nonsteriodal antiphlogistics and/ or against excipients of the IMP
- •- Presence of immunsuppression
- •- Treatment with 5-fluorouracil, cyclosporine, retinoids, glycolic acid, imiquimod, trichloroacetic acid during the trial or 12 weeks before inclusion in the trial
- •- Continuous treatment with nonsteroidal antiphlogistics with the exception of low-dose acetylsalicylic acid (100 mg) for inhibition of thrombocyte aggregation
- •- Planned treatment with photodynamic therapy during participation in the trial
- •- Pregnancy or lactation
- •- Participation in another clinical trial within 3 months before inclusion in the current trial
Investigators
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