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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 2
18 Years
N/A
Open (Enrolling)
Both
Actinic Keratosis Olsen Grade I/II

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Trial Information

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


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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Change of skin alterations during treatment period

Outcome Time Frame:

90 days: Between Visit 0 (day 0) and Visit 3 (day 90)

Safety Issue:

No

Principal Investigator

Amir Yazdi, Dr. med

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eberhard-Karls-Universität Tübingen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

KER-001

NCT ID:

NCT01757613

Start Date:

December 2012

Completion Date:

June 2013

Related Keywords:

  • Actinic Keratosis Olsen Grade I/II
  • Keratosis
  • Keratosis, Actinic

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