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

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 Overview

• Status: Completed
• Conditions: Actinic Keratosis Olsen Grade I/II
• Intervention / Treatment: Drug: AK 3012

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Blaubeuren, Germany, 89143
  • Friedrichshafen, Germany, 88045
  • Hamburg, Germany, 22391
  • Langenau, Germany, 89129
  • Radolfzell, Germany, 78315
  • Stuttgart, Germany, 70178
  • Stuttgart, Germany, 70499
  • Stuttgart, Germany, 70190
  • Tuebingen, Germany, 72076

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AK 3012 a for topical use	Drug: AK 3012; cutaneous use twice a day
Active Comparator: AK 3012 b for topical use	Drug: AK 3012; cutaneous use twice a day
Active Comparator: AK 3012 c for topical use	Drug: AK 3012; cutaneous use twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of skin alterations during treatment period	90 days: Between Visit 0 (day 0) and Visit 3 (day 90)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of visible skin alterations during treatment period		90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Tolerability of the investigated medicinal product	Tolerability will be assessed on the basis of adverse events	90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Adverse events		90 days: Between Visit 0 (day 0) and Visit 3 (day 90)

Collaborators and Investigators

• Sponsor: Dolorgiet GmbH & Co. KG
• Collaborators: d.s.h. statistical services GmbH; CenTrial GmbH
• Investigators: Principal Investigator: Amir Yazdi, Dr. med, Eberhard-Karls-Universität Tübingen; Study Director: Angelika Trapp, Dolorgiet GmbH & Co. KG

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: December 21, 2012
• First Posted (Estimate): December 31, 2012

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 13, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: KER-001; 2012-002529-30 (EudraCT Number)