Actinic keratosis Olsen grade I/II MedDRA version: 16.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Ibuprofen 5% Gel
Pharmaceutical Form: Gel
INN or Proposed INN: IBUPROFEN
CAS Number: 15687-27-1
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number:
Sponsors
Dolorgiet GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change of visible keratosis during treatment period as assessed by the Investigator Global Improvement Index (IGII) and the Patient Global Improvement Index (PGII) - Tolerance of the investigated medicinal product - Adverse events ;Timepoint(s) of evaluation of this end point: During treatment period (90 days) | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this three-armed dose-finding trial 3 ibuprofen-gels (5%, 7.5% and 10% concentration of the active agent) shall be investigated with respect to safety and efficacy in order to identify the optimal ibuprofen concentration in the gel formulation. The main objective of the trial is to determine the optimal concentration of the active agent in the gel formulation as quantified by the change of the number of keratosis (assessed by the target lesion number score - TLNS) in pre-defined areas in a time period from inclusion in the trial until the end of treatment (3 months) or prior complete healing. ;Secondary Objective: Secondary objectives are the change of visible keratosis during the treatment period as assessed by the investigator global improvement index (IGII) and the patient global improvement index (PGII) using a scale ranging from -2 (serious worsening) to +4 (healed) as well as the local skin/ dermal tolerance of the IMP and, if so, adverse events.;Primary end point(s): Change of Target Lesion Number Score (mean) during treatment period;Timepoint(s) of evaluation of this end point: During treatment period (90 days) | — |
Countries
Germany
Contacts
Public ContactAngelika Trapp, Medical Sciences
Dolorgiet GmbH & Co. KG
Outcome results
None listed