Trial | NCT01757613  Report issue

Title

Study Whose Purpose is to Find an Optimal Dose for the Treatment With AK 3012 in Patients With Actinic Keratosis
Three-armed, Randomized, Double-blind Dose-finding Trial on Efficiency and Safety of AK 3012 in 3 Different Concentrations in Patients With Actinic Keratosis Olsen Grade I/II

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ak 3012 ...

  • Study Participants

    150
In this three-armed dose-finding trial 3 AK 3012 topical formulations shall be investigated with respect to safety and efficacy in order to identify the optimal concentration in the topical formulation.

The main objective of the trial is to determine the optimal concentration of the active agent in the topical formulation as quantified by the change of the number of skin alterations in pre-defined areas in a time period from inclusion in the trial until the end of treatment (3 months) or prior complete healing.
Study Started
Dec 31
2012
Primary Completion
Jan 31
2014
Study Completion
Jan 31
2014
Last Update
May 14
2014
Estimate

Drug AK 3012

cutaneous use twice a day

AK 3012 a for topical use Active Comparator

AK 3012 b for topical use Active Comparator

AK 3012 c for topical use Active Comparator

Criteria 

Inclusion Criteria:

Age: ≥ 18 years
Gender: male and female
Actinic Keratosis (Olsen grade I/II)
at least 5 actinic keratoses on the scalp, forehead, face, extremities, and/ or decollete
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, Glutamate-Oxalacetate Transaminase (GOT),Glutamate-Pyruvate Transaminase (GPT), gamma-glutamyl transferase (GGT), Lactate dehydrogenase (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

Exclusion Criteria:

Known allergy against nonsteroidal antiphlogistics and/ or against excipients of the investigational medicinal product
Presence of immunosuppression
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
No Results Posted