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

Purpose

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	Intervention	Phase
Actinic Keratosis Olsen Grade I/II	Drug: AK 3012	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Tylosis

U.S. FDA Resources

Further study details as provided by Dolorgiet GmbH & Co. KG:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	150
Study Start Date:	December 2012
Study Completion Date:	January 2014
Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757613

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


Responsible Party:	Dolorgiet GmbH & Co. KG
ClinicalTrials.gov Identifier:	NCT01757613 History of Changes
Other Study ID Numbers:	KER-001 2012-002529-30 ( EudraCT Number )
Study First Received:	December 18, 2012
Last Updated:	May 13, 2014

Additional relevant MeSH terms:


Keratosis Keratosis, Actinic Skin Diseases Precancerous Conditions Neoplasms

ClinicalTrials.gov processed this record on September 21, 2017