Study whose purpose is to find an optimal dose for the treatment with ibuprofen gel in patients with actinic keratosis

• Conditions: Actinic keratosis Olsen grade I/II; MedDRA version: 16.1Level: 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: EUCTR2012-002529-30-DE
• Lead Sponsor: Dolorgiet GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-04
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified