Study Whose Purpose is to Find an Optimal Dose for the Treatment With AK 3012 in Patients With Actinic Keratosis

Dolorgiet

Status and phase

Completed

Phase 2

Conditions

Actinic Keratosis Olsen Grade I/II

Treatments

Drug: AK 3012

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01757613

KER-001

2012-002529-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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