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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
Sponsor:
Collaborators:
CenTrial GmbH
d.s.h. statistical services GmbH
Information provided by (Responsible Party):
Dolorgiet GmbH & Co. KG

December 18, 2012
December 31, 2012
May 14, 2014
December 2012
January 2014   (Final data collection date for primary outcome measure)
Change of skin alterations during treatment period [ Time Frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90) ]
Same as current
Complete list of historical versions of study NCT01757613 on ClinicalTrials.gov Archive Site
  • 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) ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Actinic Keratosis Olsen Grade I/II
Drug: AK 3012
cutaneous use twice a day
  • Active Comparator: AK 3012 a for topical use
    Intervention: Drug: AK 3012
  • Active Comparator: AK 3012 b for topical use
    Intervention: Drug: AK 3012
  • Active Comparator: AK 3012 c for topical use
    Intervention: Drug: AK 3012
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
Same as current
January 2014
January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01757613
KER-001
2012-002529-30 ( EudraCT Number )
No
Not Provided
Not Provided
Dolorgiet GmbH & Co. KG
Dolorgiet GmbH & Co. KG
  • CenTrial GmbH
  • d.s.h. statistical services GmbH
Principal Investigator: Amir Yazdi, Dr. med Eberhard-Karls-Universität Tübingen
Study Director: Angelika Trapp Dolorgiet GmbH & Co. KG
Dolorgiet GmbH & Co. KG
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP