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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Actinic Keratosis Olsen Grade I/II	Drug: AK 3012	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	December 2012
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	January 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Change of skin alterations during treatment period [ Time Frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90) ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Dolorgiet GmbH & Co. KG

CenTrial GmbH

d.s.h. statistical services GmbH

Investigators

Principal Investigator:	Amir Yazdi, Dr. med	Eberhard-Karls-Universität Tübingen
Study Director:	Angelika Trapp	Dolorgiet GmbH & Co. KG

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dolorgiet GmbH & Co. KG
ClinicalTrials.gov Identifier:	NCT01757613 History of Changes
Other Study ID Numbers:	KER-001; 2012-002529-30 ( EudraCT Number )
First Posted:	December 31, 2012
Last Update Posted:	May 14, 2014
Last Verified:	May 2014

Additional relevant MeSH terms:

Keratosis; Keratosis, Actinic; Skin Diseases; Precancerous Conditions; Neoplasms