Study Whose Purpose is to Find an Optimal Dose for the Treatment With AK 3012 in Patients With Actinic Keratosis
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ClinicalTrials.gov Identifier: NCT01757613 |
Recruitment Status
:
Completed
First Posted
: December 31, 2012
Last Update Posted
: May 14, 2014
|
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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 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 |
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
|
- Change of skin alterations during treatment period [ Time Frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90) ]
- 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) ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757613
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 |
Principal Investigator: | Amir Yazdi, Dr. med | Eberhard-Karls-Universität Tübingen | |
Study Director: | Angelika Trapp | Dolorgiet GmbH & Co. KG |
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 Key Record Dates |
Last Update Posted: | May 14, 2014 |
Last Verified: | May 2014 |
Additional relevant MeSH terms:
Keratosis Keratosis, Actinic Skin Diseases Precancerous Conditions Neoplasms |